Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract

Mahesh Kumar Goenka, Gajanan Ashokrao Rodge and Usha Goenka

#### Abstract

Leak, perforation, and fistula are the three main types of transmural defects in the gastrointestinal (GI) tract. Evolution of interventional endoscopic\ techniques as well as widespread use of laparoscopic and bariatric surgical procedures has contributed to the rising incidence of GI defects. The basic principle for management of leaks and fistula is to provide a barricade to the flow of luminal contents across the defect. This can be achieved either by a surgical or endoscopic method. Minimally invasive closure techniques such as clipping, stenting, suturing, and endoscopic vacuum therapy have revolutionized the management of GI defects. This chapter deals with endoscopic techniques and their present status in the management of luminal GI leaks and fistula.

Keywords: leaks, fistula, endoscopic management, through-the-scope clip, over-the-scope clip, suture, sealants, stents

#### 1. Introduction

Leak, perforation, and fistula are the three main types of transmural defects in the gastrointestinal (GI) tract. Evolution of interventional endoscopic techniques as well as widespread use of laparoscopic and bariatric surgical procedures has contributed to the rising incidence of GI defects [1–3]. Some of these defects may be serious and life-threatening and require emergency interventions. Successful endoscopic closure of gastrointestinal (GI) leaks and fistulae has shifted the management from surgery to a more conservative endoscopic approach.

Minimally invasive closure techniques such as clipping, stenting, suturing, and endoscopic vacuum therapy have revolutionized the management of GI defects [4–6]. These techniques provide a more affordable alternative to surgery with less morbidity and hospital stay. Innovations in interventional endoscopy like over-thescope clips (OTSCs) have shown promising results in closing GI defects with good safety and efficacy [7]. This chapter deals with endoscopic techniques and their present status in the management of luminal GI leaks and fistula. Pancreatic and biliary leaks, which have somewhat different approaches, are not covered in this review.


EVL: endoscopic variceal ligation; ESD: endoscopic submucosal dissection; EMR: endoscopic mucosal resection; POEM: peroral endoscopic myotomy; PEG: percutaneous endoscopic gastrostomy.

managed with fibrin glue injection and endoscopic clip closure. An esophageal stent should be placed across the fistula site following the closure for diversion of the luminal stream. Table 2 (adapted [20]) lists the different modalities which can be

Diversion Closure

• Endoclips

• Suture devices

‐ Through-the-scope clips ‐ Over-the-scope clips

• Injection of fibrin glue/cyanoacrylate

Stent placement for managing leaks and fistulae has been commonly used in the upper GI tract. The basic purpose of stenting is to cover the luminal disruption and divert the GI secretions/GI content away from the point of defect. This provides a temporary barricade to the region and prevents influx of enzymatic fluid through the opening. Therefore, preferred stents are the covered one's (at least partially covered) which can be removed once the defect is sealed. Figure 1 (adapted [20])

All of these stents are self-expanding metallic stent except for a single design of plastic stent (Polyflex, Boston, MA, USA). Fully covered stents are generally preferred in benign conditions as they can be removed easily later on. Figure 2 (adapted [20]) shows a patient with leak following gastrojejunostomy managed

Table 3 compares the different studies on esophageal stent placement for management of leaks/fistulae [21–23]. The overall stent migration rate was between 28 and 33% and is one of the major issues with use of covered stent for closing of the GI

defects. Large diameter stents (Mega stents by Niti or Danis stents by Ella;

used for endoscopic management of GI leaks and fistula.

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract

shows the different stents available to close GI defects.

successfully with a covered stent placed across the leak [20].

3.1 Luminal stenting

• Luminal stents

‐ Plastic stents

Table 2.

Figure 1.

47

Stents for GI leaks and fistula.

‐ Covered self-expandable stents

DOI: http://dx.doi.org/10.5772/intechopen.87144

Endoscopic modalities for management of leaks/fistula.

#### Table 1.

Etiology of GI leaks and fistula.

#### 2. Definitions and etiology

While the terms perforation, leak, and fistula are often used interchangeably, they in strict terms can be defined as follows:

Perforation—Acute full thickness defect in GI tract [8]. Leak—Disruption at a surgical anastomosis resulting in a fluid collection [9]. Fistula—Abnormal communication between two epithelialized surfaces [9].

Perforation occurs spontaneously or more commonly after an injury, iatrogenic or traumatic [8]. GI leaks are most commonly seen at the site of surgical anastomosis and depending on the site of anastomosis can be either intra-peritoneal or extraperitoneal. GI fistula can be internal (between GI organs) or external (between GI tract and body surface). Table 1 enumerates the various etiologies of GI leaks and fistula [10–18].

#### 3. Approach to management

The basic principle for management of leaks and fistula is to provide a barricade to the flow of luminal contents across the defect. This can be achieved either by a surgical or endoscopic method. Regardless of the chosen technique, the management requires a multi-disciplinary approach. The general measures which must be involved include: bowel rest, intravenous fluid as clinically indicated, appropriate antibiotic coverage, maintenance of nutrition, drainage of associated collection, and close hemodynamic monitoring. Proton pump inhibitors should be added in upper GI tract leaks. Contrast radiological studies help in defining and delineating the site of leak. European Society of Gastrointestinal Endoscopy (ESGE) position statement [19] recommends that endoscopic closure should be considered depending on the type of perforation, its size, and the endoscopist expertise available at the center.

Different techniques are combined together for successful closure of leaks and fistulae in many cases. For example, an esophagogastric fistula may be initially


Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract DOI: http://dx.doi.org/10.5772/intechopen.87144

Table 2.

2. Definitions and etiology

Etiology of GI leaks and fistula.

• Iatrogenic:

Advanced Endoscopy

‐ EVL ‐ Dilatation ‐ ESD/EMR ‐ POEM ‐ Trauma

• Spontaneous ‐ Boerhaave'<sup>s</sup> • Foreign body • Tuberculosis • Crohn's • Malignancy

Table 1.

‐ Diagnostic endoscopy

‐ PEG and feeding tubes ‐ Post-stenting

‐ Postsurgical anastomotic dehiscence

3. Approach to management

fistula [10–18].

46

they in strict terms can be defined as follows:

peroral endoscopic myotomy; PEG: percutaneous endoscopic gastrostomy.

Perforation—Acute full thickness defect in GI tract [8].

While the terms perforation, leak, and fistula are often used interchangeably,

EVL: endoscopic variceal ligation; ESD: endoscopic submucosal dissection; EMR: endoscopic mucosal resection; POEM:

Leak—Disruption at a surgical anastomosis resulting in a fluid collection [9]. Fistula—Abnormal communication between two epithelialized surfaces [9].

Perforation occurs spontaneously or more commonly after an injury, iatrogenic or traumatic [8]. GI leaks are most commonly seen at the site of surgical anastomosis and depending on the site of anastomosis can be either intra-peritoneal or extraperitoneal. GI fistula can be internal (between GI organs) or external (between GI tract and body surface). Table 1 enumerates the various etiologies of GI leaks and

The basic principle for management of leaks and fistula is to provide a barricade to the flow of luminal contents across the defect. This can be achieved either by a surgical or endoscopic method. Regardless of the chosen technique, the management requires a multi-disciplinary approach. The general measures which must be involved include: bowel rest, intravenous fluid as clinically indicated, appropriate antibiotic coverage, maintenance of nutrition, drainage of associated collection, and close hemodynamic monitoring. Proton pump inhibitors should be added in upper GI tract leaks. Contrast radiological studies help in defining and delineating the site of leak. European Society of Gastrointestinal Endoscopy (ESGE) position statement [19] recommends that endoscopic closure should be considered depending on the type of perforation, its size, and the endoscopist expertise available at the center. Different techniques are combined together for successful closure of leaks and fistulae in many cases. For example, an esophagogastric fistula may be initially

Endoscopic modalities for management of leaks/fistula.

managed with fibrin glue injection and endoscopic clip closure. An esophageal stent should be placed across the fistula site following the closure for diversion of the luminal stream. Table 2 (adapted [20]) lists the different modalities which can be used for endoscopic management of GI leaks and fistula.

#### 3.1 Luminal stenting

Stent placement for managing leaks and fistulae has been commonly used in the upper GI tract. The basic purpose of stenting is to cover the luminal disruption and divert the GI secretions/GI content away from the point of defect. This provides a temporary barricade to the region and prevents influx of enzymatic fluid through the opening. Therefore, preferred stents are the covered one's (at least partially covered) which can be removed once the defect is sealed. Figure 1 (adapted [20]) shows the different stents available to close GI defects.

All of these stents are self-expanding metallic stent except for a single design of plastic stent (Polyflex, Boston, MA, USA). Fully covered stents are generally preferred in benign conditions as they can be removed easily later on. Figure 2 (adapted [20]) shows a patient with leak following gastrojejunostomy managed successfully with a covered stent placed across the leak [20].

Table 3 compares the different studies on esophageal stent placement for management of leaks/fistulae [21–23]. The overall stent migration rate was between 28 and 33% and is one of the major issues with use of covered stent for closing of the GI defects. Large diameter stents (Mega stents by Niti or Danis stents by Ella;

Figure 1. Stents for GI leaks and fistula.

#### Figure 2.

(A) Contrast introduced through the surgical drain site shows site of the leak (arrow); (B and C) fully covered stent being deployed; (D) post-stenting contrast showing closure of the leak.


used successfully to close leaks following endoscopic mucosal resection (EMR) [26] and endoscopic submucosal dissection (ESD) [27]. TTSCs are usually less effective for defects of >1 cm, where another technique should be combined with TTSC. The TTSCs available from different manufacturers differ in size and mechanical properties. The most commonly used TTSCs (Figure 5) (adapted [20]) are the Quick clip (Olympus, America Inc., Center Valley, PA, USA), Instinct clip (Cook Medical Inc., Bloomington, IN, USA), and Resolution clip (Boston Scientific Inc., Natick, MA, USA). Most of the recent versions of TTSC are re-operable and rotatable; these properties allow the clips to be placed accurately and improve the clinical success. The recently introduced OTSCs can close full thickness GI defects up to 2–3 cm in diameter. The design of OTSC is different and is mounted over-the-scope tip on a

Modified stent design with extra covering or dumb-bell shape.

Through-the-scope clips from different manufacturers.

Danis stent; length—135 mm; end diameter—30 mm; mid diameter—25 mm; provided with a loop at the end

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract

DOI: http://dx.doi.org/10.5772/intechopen.87144

Figure 3.

Figure 4.

Figure 5.

49

for removal.

#### Table 3.

Comparison of studies on esophageal stent placement for management of leaks/fistulae.

Figure 3) and the modified stent designs (Figure 4) (adapted [20]) reduce the chances of stent migration [20].

#### 3.2 Endoclip closure

Endoclips, which are more commonly used for controlling GI bleed, can also be used for closing the GI wall disruptions [24]. For the first time in 1993, endoclips were used successfully for closure of a GI perforation after endoscopic removal of gastric leiomyoma [25]. Endoclips are of two types, through-the-scope clips (TTSCs) and over-the-scope clips (OTSCs). In TTSCs, the clip is loaded on the clip applicator which is introduced through the biopsy channel of the endoscope. TTSCs have been

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract DOI: http://dx.doi.org/10.5772/intechopen.87144

#### Figure 3.

Danis stent; length—135 mm; end diameter—30 mm; mid diameter—25 mm; provided with a loop at the end for removal.

#### Figure 4. Modified stent design with extra covering or dumb-bell shape.

used successfully to close leaks following endoscopic mucosal resection (EMR) [26] and endoscopic submucosal dissection (ESD) [27]. TTSCs are usually less effective for defects of >1 cm, where another technique should be combined with TTSC. The TTSCs available from different manufacturers differ in size and mechanical properties. The most commonly used TTSCs (Figure 5) (adapted [20]) are the Quick clip (Olympus, America Inc., Center Valley, PA, USA), Instinct clip (Cook Medical Inc., Bloomington, IN, USA), and Resolution clip (Boston Scientific Inc., Natick, MA, USA). Most of the recent versions of TTSC are re-operable and rotatable; these properties allow the clips to be placed accurately and improve the clinical success.

The recently introduced OTSCs can close full thickness GI defects up to 2–3 cm in diameter. The design of OTSC is different and is mounted over-the-scope tip on a

Figure 5. Through-the-scope clips from different manufacturers.

Figure 3) and the modified stent designs (Figure 4) (adapted [20]) reduce the

Comparison of studies on esophageal stent placement for management of leaks/fistulae.

(A) Contrast introduced through the surgical drain site shows site of the leak (arrow); (B and C) fully covered

Total patients included 35 31 54 Patients with leaks/fistulae 12 15 44 Stent type(s) used AliMaxx-E FCSEMS Wallflex FCSEMS SEPS, PCSEMS,

Overall technical success rate (%) 100 100 100 Closure of leak/fistula (%) 44 80 (short-term closure) 83 Overall stent migration rate (%) 33 33 28 FCSEMS: fully covered self-expandable metal stents; SEPS: self-expandable plastic stents; PCSEMS: partially covered

Eloubeidi et al. [21] Buscaglia et al. [22] El Hajj et al. [23]

FCSEMS

stent being deployed; (D) post-stenting contrast showing closure of the leak.

Endoclips, which are more commonly used for controlling GI bleed, can also be used for closing the GI wall disruptions [24]. For the first time in 1993, endoclips were used successfully for closure of a GI perforation after endoscopic removal of gastric leiomyoma [25]. Endoclips are of two types, through-the-scope clips (TTSCs) and over-the-scope clips (OTSCs). In TTSCs, the clip is loaded on the clip applicator which is introduced through the biopsy channel of the endoscope. TTSCs have been

chances of stent migration [20].

3.2 Endoclip closure

self-expandable metal stents.

Table 3.

48

Figure 2.

Advanced Endoscopy

endoscopically accessible areas of anastomotic leakage after esophagectomy and gastrectomy or after bariatric surgical procedures. The glue is applied via a double lumen catheter after removal of secretions or pus so that the targeted area becomes dry and it helps to form a fibrin clot. The underlying epithelium around the opening of the fistula is denuded with the aim of development of reactive inflammatory response around the opening. After application, the glue polymerizes on contact with moisture, causing tissue necrosis and an inflammatory response. Kotzampassi et al. used endoscopic tissue sealants (fibrin and cyanoacrylate glue) for anastomotic leakage after gastrointestinal operation and the success rate was 96.8% [33]. However, repeated sessions and large volumes of sealants may be necessary in many cases.

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract

DOI: http://dx.doi.org/10.5772/intechopen.87144

Endoscopic suturing can be used for stent fixation and closure of larger defects including fistula and perforations, although the technique is more demanding and requires expertise. The Apollo Overstitch (Apollo Endosurgery, Austin, TX, USA) is US Food and Drug Administration (FDA) approved endoscopic suture device which offers full thickness plication. It is a single unit disposable device allowing continuous or intermittent suturing with a cinching device. The device is front loaded onto a double channel endoscope (Figure 8). The major advantage of Apollo Overstitch is that it can be reloaded inside the body without any need of removing it between stitches and allows one endoscopic channel to be free. In a large multicenter retrospective study by Sharaiha et al., endoscopic suturing used for management of GI defects and/or stent anchorage was found to be safe and efficacious [34]. The technical and clinical success rates achieved were 97 and 79%, respectively. Clinical success was high for perforations (93%) and fistulas (83%), however the results were disappointing for closure of anastomotic leaks (27%) [34]. Overstitch has also been used successfully in closure of iatrogenic esophageal perforations [35], endoscopic submucosal dissection (ESD) [36], and mucosal defect after Peroral Endoscopic Myotomy (POEM) [37] and stoma reduction post-bariatric surgery [38, 39].

Vacuum-assisted closure (VAC) device is a widely used treatment modality for management of cutaneous wounds [40]. It applies negative pressure to the wound through a vacuum-sealed sponge and helps in drainage of wound secretion which

3.4 Sutures

3.5 Other techniques

Figure 8.

51

Apollo overstitch device (Apollo Endosurgery, Austin,TX, USA).

Figure 6. (A) Ovesco clip and (B) ovesco loaded on tip of endoscope.

transparent cylinder somewhat akin to variceal band ligator device. OTSCs (Figure 6A and B) from Ovesco Endoscopy (Tübingen, Germany) are nitinol, biocompatible clips with teeth ends designed in the shape of a bear trap which can produce a full thickness closure. OTSCs have a greater tissue capture and compressive strength which gives it advantage over TTSCs to close chronic leaks and fistulae even in the case of inflamed or fibrotic tissue surrounding the defect. Accessories like anchor and twin grasper, which can pull the defective mucosa into the OTS cylinder or reduce the gap of the defect, can be used for larger defects. In a large muticenter study by Chavez et al. [28], 188 patients with GI leaks and fistula were treated with OTSCs. OTS was used as primary treatment in 97 patients and as rescue therapy in 64 patients (27 patients were lost on follow-up). The success rate was 75% in first group and 47% in second group with an overall success rate of 64%.

Padlock clip (Aponos Medical Corp., Kingston, NH, USA) is a recently introduced OTSC which uses somewhat different technique and design than Ovesco (Figure 7A). The six needles on the inner aspect point toward each other help in circumferential tissue approximation at 360° due to its radial compression technology. The Padlock clip is preassembled in an open position over the tip of endoscope and is deployed by its Lock-It delivery system with a trigger wire located parallel to the scope connected to a handle (Figure 7B). Recent studies have shown Padlock clip to be safe and effective in closing GI wall defects [29, 30]. However, data regarding its clinical use is still limited.

#### 3.3 Sealants

Sealants have been used for a long time to close GI leaks and fistula, however the results are mixed with limited data. The most commonly used tissue sealants are cyanoacrylate and fibrin glue [31, 32]. The frequent sites of application include

Figure 7. (A) Padlock clip and (B) preassembled padlock clip.

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract DOI: http://dx.doi.org/10.5772/intechopen.87144

endoscopically accessible areas of anastomotic leakage after esophagectomy and gastrectomy or after bariatric surgical procedures. The glue is applied via a double lumen catheter after removal of secretions or pus so that the targeted area becomes dry and it helps to form a fibrin clot. The underlying epithelium around the opening of the fistula is denuded with the aim of development of reactive inflammatory response around the opening. After application, the glue polymerizes on contact with moisture, causing tissue necrosis and an inflammatory response. Kotzampassi et al. used endoscopic tissue sealants (fibrin and cyanoacrylate glue) for anastomotic leakage after gastrointestinal operation and the success rate was 96.8% [33]. However, repeated sessions and large volumes of sealants may be necessary in many cases.

#### 3.4 Sutures

transparent cylinder somewhat akin to variceal band ligator device. OTSCs (Figure 6A and B) from Ovesco Endoscopy (Tübingen, Germany) are nitinol, biocompatible clips with teeth ends designed in the shape of a bear trap which can produce a full thickness closure. OTSCs have a greater tissue capture and compressive strength which gives it advantage over TTSCs to close chronic leaks and fistulae even in the case of inflamed or fibrotic tissue surrounding the defect. Accessories like anchor and twin grasper, which can pull the defective mucosa into the OTS cylinder or reduce the gap of the defect, can be used for larger defects. In a large muticenter study by Chavez et al. [28], 188 patients with GI leaks and fistula were treated with OTSCs. OTS was used as primary treatment in 97 patients and as rescue therapy in 64 patients (27 patients were lost on follow-up). The success rate was 75% in first group and 47% in second group with an overall success rate of 64%. Padlock clip (Aponos Medical Corp., Kingston, NH, USA) is a recently introduced OTSC which uses somewhat different technique and design than Ovesco (Figure 7A). The six needles on the inner aspect point toward each other help in circumferential tissue approximation at 360° due to its radial compression technology. The Padlock clip is preassembled in an open position over the tip of endoscope and is deployed by its Lock-It delivery system with a trigger wire located parallel to the scope connected to a handle (Figure 7B). Recent studies have shown Padlock clip to be safe and effective in closing GI wall defects [29, 30]. However, data regarding its clinical use is still limited.

(A) Ovesco clip and (B) ovesco loaded on tip of endoscope.

Sealants have been used for a long time to close GI leaks and fistula, however the results are mixed with limited data. The most commonly used tissue sealants are cyanoacrylate and fibrin glue [31, 32]. The frequent sites of application include

3.3 Sealants

Figure 7.

50

(A) Padlock clip and (B) preassembled padlock clip.

Figure 6.

Advanced Endoscopy

Endoscopic suturing can be used for stent fixation and closure of larger defects including fistula and perforations, although the technique is more demanding and requires expertise. The Apollo Overstitch (Apollo Endosurgery, Austin, TX, USA) is US Food and Drug Administration (FDA) approved endoscopic suture device which offers full thickness plication. It is a single unit disposable device allowing continuous or intermittent suturing with a cinching device. The device is front loaded onto a double channel endoscope (Figure 8). The major advantage of Apollo Overstitch is that it can be reloaded inside the body without any need of removing it between stitches and allows one endoscopic channel to be free. In a large multicenter retrospective study by Sharaiha et al., endoscopic suturing used for management of GI defects and/or stent anchorage was found to be safe and efficacious [34]. The technical and clinical success rates achieved were 97 and 79%, respectively. Clinical success was high for perforations (93%) and fistulas (83%), however the results were disappointing for closure of anastomotic leaks (27%) [34]. Overstitch has also been used successfully in closure of iatrogenic esophageal perforations [35], endoscopic submucosal dissection (ESD) [36], and mucosal defect after Peroral Endoscopic Myotomy (POEM) [37] and stoma reduction post-bariatric surgery [38, 39].

#### 3.5 Other techniques

Vacuum-assisted closure (VAC) device is a widely used treatment modality for management of cutaneous wounds [40]. It applies negative pressure to the wound through a vacuum-sealed sponge and helps in drainage of wound secretion which

Figure 8. Apollo overstitch device (Apollo Endosurgery, Austin,TX, USA).

#### Advanced Endoscopy

promotes wound healing by increasing tissue vascularity and fresh granulation tissue. Endoscopic vacuum-assisted closure (EVAC) is a minimally invasive method which is mainly used in management of anastomotic leakage post-surgery [41, 42]. The sponge allows drainage of the leak by providing a gentle, continuous suction over tissue in contact with the sponge surface leading to a gradual reduction in the size of the wound cavity [43].

Atrial septal occluders (ASO) developed for the closure of atrial septal defects have been shown in case reports to be effective in treating GI fistulas including TEF [44, 45]. It consists of two self-expandable disks which are covered by polyester fabric and attached by a short connector that has various diameters. The other endoscopic methods used in management of GI leaks and fistula include fistula plugs [46], surgisis soft tissue grafts [47], and biodegradable stents [48]. However, more experience and data are required with these modalities to be included in routine clinical practice.

#### 3.6 Limitations

The main limitations of endoscopic management are in situations with large perforation, difficult or inaccessible endoscopic location, fibrosis at the margins of the defect, presence of abscess or fecal contamination, etc. [49]. In these conditions,

an additional procedure or surgical alternative should be considered. In cases with technical failure, where clip closure is unsuccessful, surgical intervention should be immediately considered to avoid sepsis [50]. Other complications such as perfora-

Figures 9 and 10 (adapted [51]) give a systematic approach toward management

The incidence of leaks and fistula involving the GI tract has increased in our routine practice. Only a small group of patient will respond to conservative management, while most of them will require either surgery or endoscopic manage-

endotherapy modalities to treat GI leaks and fistula. The small leaks (<10 mm) can be managed by traditional TTSCs, while the larger leaks require covered stents or OTSCs. In general, if the leak is located in proximal esophagus, distal-most esophagus, stomach, or in the right colon, clips are preferred over stents [52]. Results of

ment. Endoclips (TTSC and OTSC) and covered stents are the preferred

tion and bleeding are known with the endoscopic modalities.

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract

DOI: http://dx.doi.org/10.5772/intechopen.87144

3.7 Algorithm for management of leaks and fistula

of leaks and fistula.

Algorithm for management of fistula.

Figure 10.

4. Conclusion

53

Figure 9. Algorithm for management of leaks.

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract DOI: http://dx.doi.org/10.5772/intechopen.87144

Figure 10. Algorithm for management of fistula.

promotes wound healing by increasing tissue vascularity and fresh granulation tissue. Endoscopic vacuum-assisted closure (EVAC) is a minimally invasive method which is mainly used in management of anastomotic leakage post-surgery [41, 42]. The sponge allows drainage of the leak by providing a gentle, continuous suction over tissue in contact with the sponge surface leading to a gradual reduction in the

Atrial septal occluders (ASO) developed for the closure of atrial septal defects have been shown in case reports to be effective in treating GI fistulas including TEF [44, 45]. It consists of two self-expandable disks which are covered by polyester fabric and attached by a short connector that has various diameters. The other endoscopic methods used in management of GI leaks and fistula include fistula plugs [46], surgisis soft tissue grafts [47], and biodegradable stents [48]. However, more experience and data are required with these modalities to be included in

The main limitations of endoscopic management are in situations with large perforation, difficult or inaccessible endoscopic location, fibrosis at the margins of the defect, presence of abscess or fecal contamination, etc. [49]. In these conditions,

size of the wound cavity [43].

Advanced Endoscopy

routine clinical practice.

3.6 Limitations

Figure 9.

52

Algorithm for management of leaks.

an additional procedure or surgical alternative should be considered. In cases with technical failure, where clip closure is unsuccessful, surgical intervention should be immediately considered to avoid sepsis [50]. Other complications such as perforation and bleeding are known with the endoscopic modalities.

#### 3.7 Algorithm for management of leaks and fistula

Figures 9 and 10 (adapted [51]) give a systematic approach toward management of leaks and fistula.

#### 4. Conclusion

The incidence of leaks and fistula involving the GI tract has increased in our routine practice. Only a small group of patient will respond to conservative management, while most of them will require either surgery or endoscopic management. Endoclips (TTSC and OTSC) and covered stents are the preferred endotherapy modalities to treat GI leaks and fistula. The small leaks (<10 mm) can be managed by traditional TTSCs, while the larger leaks require covered stents or OTSCs. In general, if the leak is located in proximal esophagus, distal-most esophagus, stomach, or in the right colon, clips are preferred over stents [52]. Results of

Endovac, Plugs and Grafts, and Biodegradable stents are promising. However, larger clinical studies are required before they can be used in routine clinical practice.

In view of availability of multiple endoscopic techniques, management according to the algorithm guides the endoscopist to select the best modality based on the location, size, and associated features.

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### Author details

Mahesh Kumar Goenka<sup>1</sup> \*, Gajanan Ashokrao Rodge<sup>1</sup> and Usha Goenka<sup>2</sup>

1 Institute of Gastrosciences and Liver, Apollo Gleneagles Hospital, Kolkata, India

2 Department of Interventional Radiology and Clinical Imaging, Apollo Gleneagles Hospital, Kolkata, India

\*Address all correspondence to: mkgkolkata@gmail.com

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract DOI: http://dx.doi.org/10.5772/intechopen.87144

#### References

Endovac, Plugs and Grafts, and Biodegradable stents are promising. However, larger clinical studies are required before they can be used in routine clinical

In view of availability of multiple endoscopic techniques, management according to the algorithm guides the endoscopist to select the best modality based

\*, Gajanan Ashokrao Rodge<sup>1</sup> and Usha Goenka<sup>2</sup>

1 Institute of Gastrosciences and Liver, Apollo Gleneagles Hospital, Kolkata, India

2 Department of Interventional Radiology and Clinical Imaging, Apollo Gleneagles

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium,

\*Address all correspondence to: mkgkolkata@gmail.com

provided the original work is properly cited.

on the location, size, and associated features.

practice.

Advanced Endoscopy

Author details

Mahesh Kumar Goenka<sup>1</sup>

Hospital, Kolkata, India

54

[1] Sato H, Inoue H, Ikeda H, et al. Clinical experience of esophageal perforation occurring with endoscopic submucosal dissection. Diseases of the Esophagus. 2014;27:617-622

[2] Thirumurthi S, Raju GS. Management of polypectomy complications. Gastrointestinal Endoscopy Clinics of North America. 2015;25:335-357

[3] Zhang LP, Chang R, Matthews BD, et al. Incidence, mechanisms, and outcomes of esophageal and gastric perforation during laparoscopic foregut surgery: A retrospective review of 1,223 foregut cases. Surgical Endoscopy. 2014; 28:85-90

[4] Tringali A, Bove V, Perri V, et al. Endoscopic treatment of postlaparoscopic sleeve gastrectomy leaks using a specifically designed metal stent. Endoscopy. 2017;49:64-68

[5] Shehab H, Abdallah E, Gawdat K, et al. Large bariatric specific stents and over-the-scope clips in the management of post-bariatric surgery leaks. Obesity Surgery. 2018;28:15-24

[6] Bludau M, Fuchs HF, Herbold T, et al. Results of endoscopic vacuumassisted closure device for treatment of upper GI leaks. Surgical Endoscopy. 2018;32:1906-1914

[7] Haito-Chavez Y, Law JK, Kratt T, et al. International multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video). Gastrointestinal Endoscopy. 2014;80:610-622

[8] Singh RR, Nussbaum JS, Kumta NA. Endoscopic management of perforations, leaks and fistulas. Translational Gastroenterology and Hepatology. 2018;3:85

[9] Kumar N, Thompson CC. Endoscopic therapy for postoperative leaks and fistulae. Gastrointestinal Endoscopy Clinics of North America. 2013;23:123-136

[10] Raju GS. Endoscopic clip closure of gastrointestinal perforations, fistulae, and leaks. Digestive endoscopy. 2014;26 (Suppl 1):95-104

[11] Raymer GS, Sadana A, Campbell DB, Rowe WA. Endoscopic clip application as an adjunct to closure of mature esophageal perforation with fistulae. Clinical Gastroenterology and Hepatology. 2003;1:44-50

[12] Yoshikane H, Hidano H, Sakakibara A, Ayakawa T, Mori S, Kawashima H, et al. Endoscopic repair by clipping of iatrogenic colonic perforation. Gastrointestinal Endoscopy. 1997;46: 464-466

[13] Kim HS, Lee DK, Jeong YS, et al. Successful endoscopic management of a perforated gastric dysplastic lesion after endoscopic mucosal resection. Gastrointestinal Endoscopy. 2000;51: 613-615

[14] Rosés LL, Ramirez AG, Seco AL, et al. Clip closure of a duodenal perforation secondary to a biliary stent. Gastrointestinal Endoscopy. 2000;51: 487-489

[15] Shimamoto C, Hirata I, Umegaki E, Katsu K. Closure of an esophageal perforation due to fish bone ingestion by endoscopic clip application. Gastrointestinal Endoscopy. 2000;51: 736-739

[16] Lee SO, Jeong YJ. Colonoscopic clipping of fecal fistula that occurred as a postoperative complication in patients with perforated appendicitis: Two case reports. Gastrointestinal Endoscopy. 2001;54:245-247

[17] Cipolletta L, Bianco MA, Rotondano G, Marmo R, Piscopo R, Meucci C. Endoscopic clipping of perforation following pneumatic dilation of esophagojejunal anastomotic strictures. Endoscopy. 2000;32:720-722

[18] Rodella L, Laterza E, De Manzoni G, et al. Endoscopic clipping of anastomotic leakages in esophagogastric surgery. Endoscopy. 1998;30:453-456

[19] Paspatis GA, Dumonceau JM, Barthet M, et al. Diagnosis and management of iatrogenic endoscopic perforations: European Society of Gastrointestinal Endoscopy (ESGE) position statement. Endoscopy. 2014; 46:693-711

[20] Goenka MK, Goenka U. Endotherapy of leaks and fistula. World journal of gastrointestinal endoscopy. 2015;7:702-713

[21] Eloubeidi MA, Talreja JP, Lopes TL, et al. Success and complications associated with placement of fullycovered removable self-expandable metal stents for benign esophageal diseases. Gastrointestinal Endoscopy. 2011;73:673-681

[22] Buscaglia JM, Ho S, Sethi A, et al. Fully-covered self expandable metal stents for benign esophageal disease: A multicenter retrospective case series of 31 patients. Gastrointestinal Endoscopy. 2011;74:207-211

[23] El Hajj II, Imperiale TF, Rex DK, et al. Treatment of esophageal leaks, fistulae, and perforations with temporary stents: Evaluation of efficacy, adverse events, and factors associate with successful outcomes. Gastrointestinal Endoscopy. 2014;79: 589-598

[24] Gevers AM, De Goede E, Simoens M, Hiele M, Rutgeerts P. A randomized trial comparing injection therapy with hemoclip and with injection combined

with hemoclip for bleeding ulcers. Gastrointestinal Endoscopy. 2002;55: 466-469

[32] Pramateftakis MG, Vrakas G, Kanellos I, et al. Endoscopic application

DOI: http://dx.doi.org/10.5772/intechopen.87144

Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract

after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013;145:129-137

Kuukasjärvi P, Malmivaara A. Negative pressure wound therapy: A systematic review on effectiveness and safety. European Journal of Vascular and Endovascular Surgery. 2008;36:438-448

[41] Holle G, Riedel K, von Gregory H, Gazyakan E, Raab N, Germann G. Vacuum-assisted closure therapy. Current status and basic research [in German]. Der Unfallchirurg. 2007;

[42] Loske G, Schorsch T, Müller C. Intraluminal and intracavitary vacuum therapy for esophageal leakage: A new

approach. Endoscopy. 2011;43:540-544

[43] Weidenhagen R, Gruetzner KU, Wiecken T, Spelsberg F, Jauch KW. Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: A new method. Surgical Endoscopy. 2008;22(8):

[44] Coppola F, Boccuzzi G, Rossi G, et al. Cardiac septal umbrella for closure

Endoscopy. 2010;42(Suppl 2):E318-E319

[46] Toussaint E, Eisendrath P, Kwan V, Dugardeyn S, Devière J, Le Moine O. Endoscopic treatment of postoperative enterocutaneous fistulas after bariatric surgery with the use of a fistula plug: Report of five cases. Endoscopy. 2009;

[47] Tringali A, Daniel FB, Familiari P, et al. Endoscopic treatment of a

[45] Repici A, Presbitero P, Carlino A, et al. First human case of esophagustracheal fistula closure by using a cardiac septal occluder (with video). Gastrointestinal Endoscopy. 2010;71:

of a tracheoesophageal fistula.

endoscopic minimally invasive

110(6):490-504

1818-1825

867-869

41:560-563

[40] Vikatmaa P, Juutilainen V,

[33] Kotzampassi K, Eleftheriadis E. Tissue sealants in endoscopic applications for anastomotic leakage during a 25-year period. Surgery. 2015;

[34] Haraiha RZ, Kumta NA, DeFilippis

experience with endoscopic suturing for management of gastrointestinal defects and stent anchorage in 122 patients: A retrospective review. Journal of Clinical Gastroenterology. 2016;50:388-392

[35] Henderson JB, Sorser SA, Atia AN, Catalano MF. Repair of esophageal perforations using a novel endoscopic suturing system. Gastrointestinal Endoscopy. 2014;80:535-537

[36] Kantsevoy SV, Bitner M, Mitrakov AA, Thuluvath PJ. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointestinal Endoscopy.

[37] Stavropoulos SN, Modayil R, Friedel D. Current applications of endoscopic

Gastrointestinal Endoscopy. 2015;7:

[38] Jirapinyo P, Slattery J, Ryan MB, Abu Dayyeh BK, Lautz DB, Thompson CC. Evaluation of an endoscopic suturing device for transoral outlet reduction in patients with weight regain following Roux-en-Y gastric bypass.

[39] Thompson CC, Chand B, Chen YK, et al. Endoscopic suturing for transoral outlet reduction increases weight loss

2014;79:503-507

777-789

57

suturing. World Journal of

Endoscopy. 2013;45:532-536

EM, et al. A large multicenter

of n-butyl-2-cyanoacrylate on esophagojejunal anastomotic leak: A case report. Journal of Medical Case

Reports. 2011;5:96

157:79-86

[25] Binmoeller KF, Grimm H, Soehendra N. Endoscopic closure of a perforation using metallic clips after snare excision of a gastric leiomyoma. Gastrointestinal Endoscopy. 1993;39: 172-174

[26] Minami S, Gotoda T, Ono H, Oda I, Hamanaka H. Complete endoscopic closure of gastric perforation induced by endoscopic resection of early gastric cancer using endoclips can prevent surgery (with video). Gastrointestinal Endoscopy. 2006;63:596-601

[27] Jeon SW, Jung MK, Kim SK, et al. Clinical outcomes for perforations during endoscopic submucosal dissection in patients with gastric lesions. Surgical Endoscopy. 2010;24: 911-916

[28] Chavez YH, Kratt T, Law JK, et al. A large international multicenter experience with an over-the-scope clipping device for endoscopic management of gastrointestinal perforations, fistulae, and leaks in 188 Patients. Gastrointestinal Endoscopy. 2013;77:AB148-AB149

[29] Armellini E, Crinò SF, Orsello M, et al. Novel endoscopic over-the-scope clip system. World Journal of Gastroenterology. 2015;21:13587

[30] Dinelli M, Omazzi B, Andreozzi P, Zucchini N, Redaelli A, Manes G. First clinical experiences with a novel endoscopic over-the-scope clip system. Endoscopy international open. 2017;5: E151

[31] Rábago LR, Ventosa N, Castro JL, Marco J, Herrera N, Gea F. Endoscopic treatment of postoperative fistulas resistant to conservative management using biological fibrin glue. Endoscopy. 2002;34:632-638

#### Endoscopic Management of Leaks and Fistula in Gastrointestinal Tract DOI: http://dx.doi.org/10.5772/intechopen.87144

[32] Pramateftakis MG, Vrakas G, Kanellos I, et al. Endoscopic application of n-butyl-2-cyanoacrylate on esophagojejunal anastomotic leak: A case report. Journal of Medical Case Reports. 2011;5:96

[17] Cipolletta L, Bianco MA, Rotondano G, Marmo R, Piscopo R, Meucci C. Endoscopic clipping of perforation following pneumatic dilation of

with hemoclip for bleeding ulcers. Gastrointestinal Endoscopy. 2002;55:

[25] Binmoeller KF, Grimm H,

Endoscopy. 2006;63:596-601

[27] Jeon SW, Jung MK, Kim SK, et al. Clinical outcomes for perforations during endoscopic submucosal dissection in patients with gastric lesions. Surgical Endoscopy. 2010;24:

[28] Chavez YH, Kratt T, Law JK, et al. A

[29] Armellini E, Crinò SF, Orsello M, et al. Novel endoscopic over-the-scope

[30] Dinelli M, Omazzi B, Andreozzi P, Zucchini N, Redaelli A, Manes G. First clinical experiences with a novel endoscopic over-the-scope clip system. Endoscopy international open. 2017;5:

[31] Rábago LR, Ventosa N, Castro JL, Marco J, Herrera N, Gea F. Endoscopic treatment of postoperative fistulas resistant to conservative management using biological fibrin glue. Endoscopy.

clip system. World Journal of Gastroenterology. 2015;21:13587

large international multicenter experience with an over-the-scope clipping device for endoscopic management of gastrointestinal perforations, fistulae, and leaks in 188 Patients. Gastrointestinal Endoscopy.

2013;77:AB148-AB149

Soehendra N. Endoscopic closure of a perforation using metallic clips after snare excision of a gastric leiomyoma. Gastrointestinal Endoscopy. 1993;39:

[26] Minami S, Gotoda T, Ono H, Oda I, Hamanaka H. Complete endoscopic closure of gastric perforation induced by endoscopic resection of early gastric cancer using endoclips can prevent surgery (with video). Gastrointestinal

466-469

172-174

911-916

E151

2002;34:632-638

esophagojejunal anastomotic strictures.

[18] Rodella L, Laterza E, De Manzoni G,

anastomotic leakages in esophagogastric surgery. Endoscopy. 1998;30:453-456

[19] Paspatis GA, Dumonceau JM, Barthet M, et al. Diagnosis and management of iatrogenic endoscopic perforations: European Society of Gastrointestinal Endoscopy (ESGE) position statement. Endoscopy. 2014;

Endoscopy. 2000;32:720-722

Advanced Endoscopy

et al. Endoscopic clipping of

[20] Goenka MK, Goenka U.

Endotherapy of leaks and fistula. World journal of gastrointestinal endoscopy.

[21] Eloubeidi MA, Talreja JP, Lopes TL,

[22] Buscaglia JM, Ho S, Sethi A, et al. Fully-covered self expandable metal stents for benign esophageal disease: A multicenter retrospective case series of 31 patients. Gastrointestinal Endoscopy.

[23] El Hajj II, Imperiale TF, Rex DK, et al. Treatment of esophageal leaks, fistulae, and perforations with

with successful outcomes.

temporary stents: Evaluation of efficacy, adverse events, and factors associate

Gastrointestinal Endoscopy. 2014;79:

[24] Gevers AM, De Goede E, Simoens M, Hiele M, Rutgeerts P. A randomized trial comparing injection therapy with hemoclip and with injection combined

et al. Success and complications associated with placement of fullycovered removable self-expandable metal stents for benign esophageal diseases. Gastrointestinal Endoscopy.

46:693-711

2015;7:702-713

2011;73:673-681

2011;74:207-211

589-598

56

[33] Kotzampassi K, Eleftheriadis E. Tissue sealants in endoscopic applications for anastomotic leakage during a 25-year period. Surgery. 2015; 157:79-86

[34] Haraiha RZ, Kumta NA, DeFilippis EM, et al. A large multicenter experience with endoscopic suturing for management of gastrointestinal defects and stent anchorage in 122 patients: A retrospective review. Journal of Clinical Gastroenterology. 2016;50:388-392

[35] Henderson JB, Sorser SA, Atia AN, Catalano MF. Repair of esophageal perforations using a novel endoscopic suturing system. Gastrointestinal Endoscopy. 2014;80:535-537

[36] Kantsevoy SV, Bitner M, Mitrakov AA, Thuluvath PJ. Endoscopic suturing closure of large mucosal defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointestinal Endoscopy. 2014;79:503-507

[37] Stavropoulos SN, Modayil R, Friedel D. Current applications of endoscopic suturing. World Journal of Gastrointestinal Endoscopy. 2015;7: 777-789

[38] Jirapinyo P, Slattery J, Ryan MB, Abu Dayyeh BK, Lautz DB, Thompson CC. Evaluation of an endoscopic suturing device for transoral outlet reduction in patients with weight regain following Roux-en-Y gastric bypass. Endoscopy. 2013;45:532-536

[39] Thompson CC, Chand B, Chen YK, et al. Endoscopic suturing for transoral outlet reduction increases weight loss

after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013;145:129-137

[40] Vikatmaa P, Juutilainen V, Kuukasjärvi P, Malmivaara A. Negative pressure wound therapy: A systematic review on effectiveness and safety. European Journal of Vascular and Endovascular Surgery. 2008;36:438-448

[41] Holle G, Riedel K, von Gregory H, Gazyakan E, Raab N, Germann G. Vacuum-assisted closure therapy. Current status and basic research [in German]. Der Unfallchirurg. 2007; 110(6):490-504

[42] Loske G, Schorsch T, Müller C. Intraluminal and intracavitary vacuum therapy for esophageal leakage: A new endoscopic minimally invasive approach. Endoscopy. 2011;43:540-544

[43] Weidenhagen R, Gruetzner KU, Wiecken T, Spelsberg F, Jauch KW. Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: A new method. Surgical Endoscopy. 2008;22(8): 1818-1825

[44] Coppola F, Boccuzzi G, Rossi G, et al. Cardiac septal umbrella for closure of a tracheoesophageal fistula. Endoscopy. 2010;42(Suppl 2):E318-E319

[45] Repici A, Presbitero P, Carlino A, et al. First human case of esophagustracheal fistula closure by using a cardiac septal occluder (with video). Gastrointestinal Endoscopy. 2010;71: 867-869

[46] Toussaint E, Eisendrath P, Kwan V, Dugardeyn S, Devière J, Le Moine O. Endoscopic treatment of postoperative enterocutaneous fistulas after bariatric surgery with the use of a fistula plug: Report of five cases. Endoscopy. 2009; 41:560-563

[47] Tringali A, Daniel FB, Familiari P, et al. Endoscopic treatment of a

recalcitrant esophageal fistula with new tools: Stents, surgisis, and nitinol staples (with video). Gastrointestinal Endoscopy. 2010;72:647-650

[48] Černá M, Köcher M, Válek V, et al. Covered biodegradable stent: New therapeutic option for the management of esophageal perforation or anastomotic leak. Cardiovascular and Interventional Radiology. 2011;34: 1267-1271

[49] Dişibeyaz S, Köksal AŞ, Parlak E, Torun S, Şaşmaz N. Endoscopic closure of gastrointestinal defects with an overthe-scope clip device. A case series and review of the literature. Clinics and Research in Hepatology and Gastroenterology. 2012;36:614-621

[50] Cho SB, Lee WS, Joo YE, et al. Therapeutic options for iatrogenic colon perforation: Feasibility of endoscopic clip closure and predictors of the need for early surgery. Surgical Endoscopy. 2012;26:473-479

[51] Devaraj P, Gavini H. Endoscopic management of postoperative fistulas and leaks. Gastrointestinal Intervention. 2017;6:54-62

[52] Fischer A, Schrag HJ, Goos M, von Dobschuetz E, Hopt UT. Nonoperative treatment of four esophageal perforations with hemostatic clips. Diseases of the Esophagus. 2007;20: 444-448

**59**

ated literature.

**Chapter 5**

**Abstract**

conditions.

**1. Introduction**

EUS-Guided Biliary Drainage

**Keywords:** EUS-guided biliary drainage, EUS-BD, EUS, endoscopic ultrasound-guided biliary drainage, ERCP, endoscopic retrograde

cholangiopancreatography, PTBD, percutaneous transhepatic biliary drainage

Biliary drainage under endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard and is an established technique for malignant biliary obstruction. However, successful selective biliary cannulation is not always obtained. In addition, if the case is complicated by malignant gastroduodenal obstruction or surgically altered anatomy preventing advance of the endoscope into the ampulla of Vater, ERCP itself may not be indicated. As an alternative biliary drainage technique, percutaneous transhepatic biliary drainage (PTBD) is another established technique. However, this alternative may also be contraindicated for patients with massive ascites and shows several disadvantages such as risk of selftube removal or cosmetic problems. Endoscopic ultrasound (EUS)-guided biliary drainage (BD) has recently been developed as a novel alternative biliary drainage technique. EUS-BD can be divided into two main approach routes: transgastric and transduodenal. In addition, EUS-guided hepaticogastrostomy (HGS), choledochoduodenostomy (CDS), and gallbladder drainage (GBD) have been reported. In this chapter, we provide technical tips for each basic technique and review the associ-

Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been developed as an alternative method for failed endoscopic retrograde cholangiopancreatography (ERCP). EUS-BD can be divided into two main approach routes, such as transgastric or transduodenal approach. Also, EUS-guided hepaticogastrostomy, choledochoduodenostomy (CDS), and gallbladder drainage (GBD) have been reported. In this chapter, we described technical tips for each basic technique, including literature review. As advanced technique of EUS-BD, antegrade stone removal has been reported. More recently, electrohydraulic lithotripsy for bile duct stones under transluminal cholangioscopy guidance, hepaticojejunostomy stricture dilation through EUS-hepaticogastrostomy (HGS) route, or EUS-guided gastrojejunostomy has been reported. Although EUS-BD has various potential as treatment technique, treatment method should be selected for each patient's

*Takeshi Ogura and Kazuhide Higuchi*

## **Chapter 5** EUS-Guided Biliary Drainage

*Takeshi Ogura and Kazuhide Higuchi*

#### **Abstract**

recalcitrant esophageal fistula with new tools: Stents, surgisis, and nitinol staples

[48] Černá M, Köcher M, Válek V, et al. Covered biodegradable stent: New therapeutic option for the management

anastomotic leak. Cardiovascular and Interventional Radiology. 2011;34:

[49] Dişibeyaz S, Köksal AŞ, Parlak E, Torun S, Şaşmaz N. Endoscopic closure of gastrointestinal defects with an overthe-scope clip device. A case series and review of the literature. Clinics and

(with video). Gastrointestinal Endoscopy. 2010;72:647-650

Advanced Endoscopy

of esophageal perforation or

Research in Hepatology and Gastroenterology. 2012;36:614-621

2012;26:473-479

2017;6:54-62

444-448

58

[50] Cho SB, Lee WS, Joo YE, et al. Therapeutic options for iatrogenic colon perforation: Feasibility of endoscopic clip closure and predictors of the need for early surgery. Surgical Endoscopy.

[51] Devaraj P, Gavini H. Endoscopic management of postoperative fistulas and leaks. Gastrointestinal Intervention.

[52] Fischer A, Schrag HJ, Goos M, von Dobschuetz E, Hopt UT. Nonoperative

treatment of four esophageal perforations with hemostatic clips. Diseases of the Esophagus. 2007;20:

1267-1271

Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been developed as an alternative method for failed endoscopic retrograde cholangiopancreatography (ERCP). EUS-BD can be divided into two main approach routes, such as transgastric or transduodenal approach. Also, EUS-guided hepaticogastrostomy, choledochoduodenostomy (CDS), and gallbladder drainage (GBD) have been reported. In this chapter, we described technical tips for each basic technique, including literature review. As advanced technique of EUS-BD, antegrade stone removal has been reported. More recently, electrohydraulic lithotripsy for bile duct stones under transluminal cholangioscopy guidance, hepaticojejunostomy stricture dilation through EUS-hepaticogastrostomy (HGS) route, or EUS-guided gastrojejunostomy has been reported. Although EUS-BD has various potential as treatment technique, treatment method should be selected for each patient's conditions.

**Keywords:** EUS-guided biliary drainage, EUS-BD, EUS, endoscopic ultrasound-guided biliary drainage, ERCP, endoscopic retrograde cholangiopancreatography, PTBD, percutaneous transhepatic biliary drainage

#### **1. Introduction**

Biliary drainage under endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard and is an established technique for malignant biliary obstruction. However, successful selective biliary cannulation is not always obtained. In addition, if the case is complicated by malignant gastroduodenal obstruction or surgically altered anatomy preventing advance of the endoscope into the ampulla of Vater, ERCP itself may not be indicated. As an alternative biliary drainage technique, percutaneous transhepatic biliary drainage (PTBD) is another established technique. However, this alternative may also be contraindicated for patients with massive ascites and shows several disadvantages such as risk of selftube removal or cosmetic problems. Endoscopic ultrasound (EUS)-guided biliary drainage (BD) has recently been developed as a novel alternative biliary drainage technique. EUS-BD can be divided into two main approach routes: transgastric and transduodenal. In addition, EUS-guided hepaticogastrostomy (HGS), choledochoduodenostomy (CDS), and gallbladder drainage (GBD) have been reported. In this chapter, we provide technical tips for each basic technique and review the associated literature.

#### **2. EUS-guided biliary drainage**

#### **2.1 EUS-guided CDS**

#### *2.1.1 Indications*

EUS-CDS is mainly attempted for patients with failed endoscopic balloon dilation (EBD) excluded prospective clinical trial, as previously described [1, 2]. This procedure can be performed for obstructions in the middle and lower bile duct. This indicates that pancreatobiliary carcinoma is the main indication for EUS-CDS. EUS-CDS is contraindicated in patients with surgically altered anatomy, such as a Roux-en-Y anastomosis or tumor invasion-associated duodenal obstruction through which an endoscope cannot be passed. In such cases, EUS-guided hepaticogastrostomy may be indicated. However, if the duodenal bulb is not involved, EUS-CDS can be performed in combination with duodenal stenting. Optimal indications regarding EUS-CDS versus ERCP for benign disease have not been defined, completely. Prospective randomized controlled studies between ERCP and EUS-CDS are therefore needed to assess the clinical efficacy of the procedure. Indications for EUS-CDS are the following: (1) failed EBD including inaccessibility of the Vater, such as that caused by malignant duodenal obstruction, (2) contraindications for percutaneous transhepatic cholangiography drainage (PTCD), and (3) middle or lower bile duct obstruction. EUS-CDS has recently been attempted as a first-line drainage technique. According to randomized controlled trials [3, 4], EUS-CDS offers similar safety to ERCP. In addition, EUS-CDS may result in fewer cases of tumor ingrowth but may also be associated with greater frequencies of food impaction or stent migration. Further high-quality randomized trials are needed.

#### *2.1.2 Technical tips*

The EUS scope is introduced into the duodenum, turned slightly to the left, and angled downward to identify the common bile duct (CBD) on EUS. To avoid any intervening vessels, the CBD should be punctured using a 19-G needle under color Doppler guidance. Then, bile juice is aspirated to be ensure the biliary tract, and the contrast medium is injected to obtain image of the CBD. During this step, avoiding puncture of the duodenal mucosa [5, 6] and cystic duct is important. When a double duodenal mucosal line is visualized on EUS, the CBD should not be punctured to avoid puncture and stenting through the double duodenal mucosa. To prevent this adverse event, a water-filling technique may be impactful [5]. After guidewire insertion, to insert the stent delivery system, dilation for the duodenal and CBD wall is sometimes needed. Various devices have been described for dilatation of the fistula after puncturing the CBD. The most common devices for transmural tract dilation are the dilator (6 to 10 Fr), balloon catheter (4–8 mm), and needle knife. Park et al. described that the overall complication rate for EUS-CDS and EUS-HGS was 27% (15/55) [7]. As risk factor for complication associated with EUS-BD (P = 0.01, HR 12.4, 95%CI, 1.83–83.5), the use of a needle knife for fistula dilation is identified. Because of the acute angulation of the scope, following deployment of the catheter at the duodenum, the needle knife points tangentially when deployed. This can lead to accidental incision with a chance of pneumoperitoneum or bleeding. Therefore, the author's conclusion is that fistula dilation should be avoided to prevent procedural complication. The next step is stent deployment (**Figures 1**–**3**).

Endoscopist can select both plastic and metallic stents during EUS-CDS as drainage device. Plastic stents with diameters ranging from 5 to 10 Fr were commonly used according to previous reports. A 7- or 8.5-Fr plastic stent is used,

**61**

stents.

**Figure 2.**

*EUS-Guided Biliary Drainage*

**Figure 1.**

*DOI: http://dx.doi.org/10.5772/intechopen.87970*

*The common bile duct is punctured using 19-G needle from the duodenal bulb.*

because the diameter of the working channel is 3.7 mm. However, bile leakage can occur with plastic stent placement (**Figure 6**). This patient experienced high fever and abdominal pain for up to 3 days after EUS-CDS, and bile leakage was seen according to computed tomography and duodenoscopy. If a large fistula is created before stent deployment, bile leakage from the gap between fistula and the stent is likely to occur because plastic stent is fine gauge compared with metal stent. On the other hand, although no comparative studies appear to have been conducted, metallic stents are expected to offer several clinical benefits. First, because of their large diameter, metallic stents tend to remain in the patent longer than plastic

*The covered metal stent deployment is performed from the common bile duct to the duodenum.*

Second, bile leakage is less likely because of the close proximity between the metallic stent and duodenal and bile duct wall. If an uncovered metallic stent is used, however, bile leakage can easily occur, which sometimes proves fatal. Therefore, covered self-expandable metal stents (SEMSs) should be used. However, although SEMSs can prevent bile leakage, the side branch of biliary tract may be occluded. This suggests that if the distance between the puncture site and hepatic

*EUS-Guided Biliary Drainage DOI: http://dx.doi.org/10.5772/intechopen.87970*

#### **Figure 1.**

*Advanced Endoscopy*

**2.1 EUS-guided CDS**

*2.1.1 Indications*

*2.1.2 Technical tips*

**2. EUS-guided biliary drainage**

EUS-CDS is mainly attempted for patients with failed endoscopic balloon dilation (EBD) excluded prospective clinical trial, as previously described [1, 2]. This procedure can be performed for obstructions in the middle and lower bile duct. This indicates that pancreatobiliary carcinoma is the main indication for EUS-CDS. EUS-CDS is contraindicated in patients with surgically altered anatomy, such as a

Roux-en-Y anastomosis or tumor invasion-associated duodenal obstruction through which an endoscope cannot be passed. In such cases, EUS-guided hepaticogastrostomy may be indicated. However, if the duodenal bulb is not involved, EUS-CDS can be performed in combination with duodenal stenting. Optimal indications regarding EUS-CDS versus ERCP for benign disease have not been defined, completely. Prospective randomized controlled studies between ERCP and EUS-CDS are therefore needed to assess the clinical efficacy of the procedure. Indications for EUS-CDS are the following: (1) failed EBD including inaccessibility of the Vater, such as that caused by malignant duodenal obstruction, (2) contraindications for percutaneous transhepatic cholangiography drainage (PTCD), and (3) middle or lower bile duct obstruction. EUS-CDS has recently been attempted as a first-line drainage technique. According to randomized controlled trials [3, 4], EUS-CDS offers similar safety to ERCP. In addition, EUS-CDS may result in fewer cases of tumor ingrowth but may also be associated with greater frequencies of food impac-

tion or stent migration. Further high-quality randomized trials are needed.

The EUS scope is introduced into the duodenum, turned slightly to the left, and angled downward to identify the common bile duct (CBD) on EUS. To avoid any intervening vessels, the CBD should be punctured using a 19-G needle under color Doppler guidance. Then, bile juice is aspirated to be ensure the biliary tract, and the contrast medium is injected to obtain image of the CBD. During this step, avoiding puncture of the duodenal mucosa [5, 6] and cystic duct is important. When a double duodenal mucosal line is visualized on EUS, the CBD should not be punctured to avoid puncture and stenting through the double duodenal mucosa. To prevent this adverse event, a water-filling technique may be impactful [5]. After guidewire insertion, to insert the stent delivery system, dilation for the duodenal and CBD wall is sometimes needed. Various devices have been described for dilatation of the fistula after puncturing the CBD. The most common devices for transmural tract dilation are the dilator (6 to 10 Fr), balloon catheter (4–8 mm), and needle knife. Park et al. described that the overall complication rate for EUS-CDS and EUS-HGS was 27% (15/55) [7]. As risk factor for complication associated with EUS-BD (P = 0.01, HR 12.4, 95%CI, 1.83–83.5), the use of a needle knife for fistula dilation is identified. Because of the acute angulation of the scope, following deployment of the catheter at the duodenum, the needle knife points tangentially when deployed. This can lead to accidental incision with a chance of pneumoperitoneum or bleeding. Therefore, the author's conclusion is that fistula dilation should be avoided to prevent procedural complication. The next step is stent deployment (**Figures 1**–**3**). Endoscopist can select both plastic and metallic stents during EUS-CDS as drainage device. Plastic stents with diameters ranging from 5 to 10 Fr were commonly used according to previous reports. A 7- or 8.5-Fr plastic stent is used,

**60**

*The common bile duct is punctured using 19-G needle from the duodenal bulb.*

#### **Figure 2.** *The covered metal stent deployment is performed from the common bile duct to the duodenum.*

because the diameter of the working channel is 3.7 mm. However, bile leakage can occur with plastic stent placement (**Figure 6**). This patient experienced high fever and abdominal pain for up to 3 days after EUS-CDS, and bile leakage was seen according to computed tomography and duodenoscopy. If a large fistula is created before stent deployment, bile leakage from the gap between fistula and the stent is likely to occur because plastic stent is fine gauge compared with metal stent. On the other hand, although no comparative studies appear to have been conducted, metallic stents are expected to offer several clinical benefits. First, because of their large diameter, metallic stents tend to remain in the patent longer than plastic stents.

Second, bile leakage is less likely because of the close proximity between the metallic stent and duodenal and bile duct wall. If an uncovered metallic stent is used, however, bile leakage can easily occur, which sometimes proves fatal. Therefore, covered self-expandable metal stents (SEMSs) should be used. However, although SEMSs can prevent bile leakage, the side branch of biliary tract may be occluded. This suggests that if the distance between the puncture site and hepatic

**Figure 3.** *Metal stent is placed in the duodenum bulb.*

hilar portion is short, a partially covered SEMS should be selected to prevent occlusion of the intrahepatic bile duct. However, if EUS-CDS is performed using by a partially covered SEMS, bile leakage can occur from the uncovered site, particularly between the bile duct and duodenum. A challenging complication is stent migration during EUS-BD. In the use of a standard metallic stent in EUS-CDS, some authors have found that a double-pigtail plastic stent should be placed inside the metal stent to prevent stent migration. To prevent stent migration, standard SEMSs with a wide flange should be used, and stent shortening to a length of 60 mm may be preferable. Recently, a novel SEMS has been available. The lumen-apposing metal stent (LAMS) (NAGI Stent; Taewoong Medical Co., Seoul, Korea) is a 10.5-Fr delivery system and consists of a fully covered, 20-mm-long, 16-mm-diameter stent. The hot AXIOS stent (Xlumena, Inc., Mountain View, CA, USA) is a fully covered, 10-mm-diameter delivery system, with 10-mm-long braided stent with bilateral 20-mm-diameter anchor flanges. These novel SEMSs are mainly used for EUS-guided pseudocystic drainage and EUS-guided cholecystogastrostomy [8–10]. These SEMSs also seem useful for EUS-CDS, although clinical trials are needed to confirm their utility.

#### *2.1.3 Clinical results*

According to a recent meta-analysis including 572 patients [11], the pooled rate of all adverse events was 0.136 (95% CI, 0.097–0.188; P = 0.01) with moderate heterogeneity (I = 56.9), and pooled rates were 4.2% for cholangitis, 4.1% for bleeding, 3.7% for bile leakage, and 2.9% for perforation. On subgroup analysis, the pooled rate of adverse events with the use of lumen-apposing metal stents was 9.3% (95%CI, 4.8–17.3%). On the other hand, the rate of adverse events such as cholangitis, bleeding, and bile leakage was 13.4%.

#### **2.2 EUS-guided HGS**

#### *2.2.1 Indications*

EUS-HGS should be indicated for failed ERCP due to surgical anatomy or inaccessible ampulla of Vater, because adverse events such as stent migration can sometimes prove fatal. However, although EUS-CDS cannot be attempted in patients complicated with surgical anatomy, such as Roux-en-Y anastomosis or

**63**

*2.2.2 Technical tips*

*EUS-Guided Biliary Drainage*

*DOI: http://dx.doi.org/10.5772/intechopen.87970*

malignant duodenal obstruction, EUS-HGS can be attempted because the access route of EUS-HGS is the stomach. Regarding biliary stricture sites, EUS-HGS may be challenging in case of hepatic hilum stricture because stent deployment is performed from the left intrahepatic bile duct. Therefore, the right hepatic bile duct cannot drain. As expanding indication, EUS-BD for right hepatic bile duct obstruction has been developed [12, 13]. Park et al. [12] reported that EUS-guided biliary access is successfully performed in antegrade bypass stenting (n = 2), antegrade transanastomotic stenting (n = 1), antegrade transanastomotic balloon dilation (n = 1), and the use of the cholangiogram as a roadmap (n = 1) among six patients with isolated right hepatic bile duct obstruction. We also conducted that EUS-BD was successfully performed using bridging method (n = 7) and locking stent method (n = 4) among 11 patients with right hepatic bile duct obstruction [13]. No severe adverse events were identified in either study. EUS-HGS has potential as indication for hepatic hilar stricture. However, because it is technically challenging, the right hepatic approach under EUS guidance should be performed for selected patients. Recently, Khashab et al. [14] reported a comparative evaluation of PTCD and EUS-BD in patients who were complicated with distal malignant biliary obstruction. According to this study, although the technical success rate was higher in the PTCD than in EUS-BD (100% vs. 86.4%, P = 0.007), clinical success and stent patency were not different. Rates of adverse event (70.6% vs. 18.2%, P < 0.001) and total charges were significantly higher in the PTCD (\$9.072 ± 3.817 vs. \$18.261 ± 16.021, P = 0.003). Therefore, their conclusion is that EUS-BD might be preferred if EUS-BD can be performed by experienced endoscopists. However, there are several limitations such as small number of patients, a single-center study, and a single operator. Therefore, to determine whether EUS-HGS or PTCD should be performed in a multicenter, prospective randomized controlled study is needed. The current indications for EUS-HGS are the following: (1) failed ERCP, (2) inaccessibility of the Vater due to surgical anatomy or duodenal obstruction caused by the tumor, and (3) contraindications for PTCD due to massive ascites and risk of self-tube removal. Compared with PTCD, metallic stent placement can be used in EUS-HGS in primary session. Therefore, EUS-HGS may be indicated even if a small amount of ascites is present in the access route. However, if massive ascites is present, preventing the formation of fistula between the stomach and liver, EUS-HGS is not indicated. The contraindications for EUS-HGS are the following: (1) massive

ascites between the stomach and liver and (2) unresectable gastric cancer.

The EUS device is introduced into the stomach. Then, using counterclockwise rotation, the left hepatic lobe can be identified. A 19-G FNA needle may be better than a 22-G. A stiffer guidewire is inserted into the biliary tract through the EUS-fine needle aspiration (FNA) needle because fistula dilation is an important point to insert the stent delivery system compared with EUS-CDS. If segment 2 (B2) is punctured, because devices can be passed across the mediastinum, when puncturing from the esophagus, severe adverse events such as mediastinitis or pneumomediastinum may occur. Therefore, segment 3 (B3) should be initially punctured. There are two important points regarding the intrahepatic bile duct puncture. The first point is the angle of the bile duct, and the second point is the volume of the liver parenchyma. The bile duct that runs from the upper left to the lower right based on EUS imaging should be punctured to advance the guidewire toward the hepatic hilum. Furthermore, avoiding stent migration into the abdominal cavity requires a sufficient volume of liver parenchyma to obtain anchoring function, like PTCD procedure**.** Therefore, B3 is better as puncturing site. The next

#### *EUS-Guided Biliary Drainage DOI: http://dx.doi.org/10.5772/intechopen.87970*

*Advanced Endoscopy*

**Figure 3.**

*Metal stent is placed in the duodenum bulb.*

hilar portion is short, a partially covered SEMS should be selected to prevent occlusion of the intrahepatic bile duct. However, if EUS-CDS is performed using by a partially covered SEMS, bile leakage can occur from the uncovered site, particularly between the bile duct and duodenum. A challenging complication is stent migration during EUS-BD. In the use of a standard metallic stent in EUS-CDS, some authors have found that a double-pigtail plastic stent should be placed inside the metal stent to prevent stent migration. To prevent stent migration, standard SEMSs with a wide flange should be used, and stent shortening to a length of 60 mm may be preferable. Recently, a novel SEMS has been available. The lumen-apposing metal stent (LAMS) (NAGI Stent; Taewoong Medical Co., Seoul, Korea) is a 10.5-Fr delivery system and consists of a fully covered, 20-mm-long, 16-mm-diameter stent. The hot AXIOS stent (Xlumena, Inc., Mountain View, CA, USA) is a fully covered, 10-mm-diameter delivery system, with 10-mm-long braided stent with bilateral 20-mm-diameter anchor flanges. These novel SEMSs are mainly used for EUS-guided pseudocystic drainage and EUS-guided cholecystogastrostomy [8–10]. These SEMSs also seem useful for EUS-CDS, although clinical trials are needed to

According to a recent meta-analysis including 572 patients [11], the pooled rate of all adverse events was 0.136 (95% CI, 0.097–0.188; P = 0.01) with moderate heterogeneity (I = 56.9), and pooled rates were 4.2% for cholangitis, 4.1% for bleeding, 3.7% for bile leakage, and 2.9% for perforation. On subgroup analysis, the pooled rate of adverse events with the use of lumen-apposing metal stents was 9.3% (95%CI, 4.8–17.3%). On the other hand, the rate of adverse events such as cholangi-

EUS-HGS should be indicated for failed ERCP due to surgical anatomy or inaccessible ampulla of Vater, because adverse events such as stent migration can sometimes prove fatal. However, although EUS-CDS cannot be attempted in patients complicated with surgical anatomy, such as Roux-en-Y anastomosis or

**62**

confirm their utility.

*2.1.3 Clinical results*

**2.2 EUS-guided HGS**

*2.2.1 Indications*

tis, bleeding, and bile leakage was 13.4%.

malignant duodenal obstruction, EUS-HGS can be attempted because the access route of EUS-HGS is the stomach. Regarding biliary stricture sites, EUS-HGS may be challenging in case of hepatic hilum stricture because stent deployment is performed from the left intrahepatic bile duct. Therefore, the right hepatic bile duct cannot drain. As expanding indication, EUS-BD for right hepatic bile duct obstruction has been developed [12, 13]. Park et al. [12] reported that EUS-guided biliary access is successfully performed in antegrade bypass stenting (n = 2), antegrade transanastomotic stenting (n = 1), antegrade transanastomotic balloon dilation (n = 1), and the use of the cholangiogram as a roadmap (n = 1) among six patients with isolated right hepatic bile duct obstruction. We also conducted that EUS-BD was successfully performed using bridging method (n = 7) and locking stent method (n = 4) among 11 patients with right hepatic bile duct obstruction [13]. No severe adverse events were identified in either study. EUS-HGS has potential as indication for hepatic hilar stricture. However, because it is technically challenging, the right hepatic approach under EUS guidance should be performed for selected patients. Recently, Khashab et al. [14] reported a comparative evaluation of PTCD and EUS-BD in patients who were complicated with distal malignant biliary obstruction. According to this study, although the technical success rate was higher in the PTCD than in EUS-BD (100% vs. 86.4%, P = 0.007), clinical success and stent patency were not different. Rates of adverse event (70.6% vs. 18.2%, P < 0.001) and total charges were significantly higher in the PTCD (\$9.072 ± 3.817 vs. \$18.261 ± 16.021, P = 0.003). Therefore, their conclusion is that EUS-BD might be preferred if EUS-BD can be performed by experienced endoscopists. However, there are several limitations such as small number of patients, a single-center study, and a single operator. Therefore, to determine whether EUS-HGS or PTCD should be performed in a multicenter, prospective randomized controlled study is needed. The current indications for EUS-HGS are the following: (1) failed ERCP, (2) inaccessibility of the Vater due to surgical anatomy or duodenal obstruction caused by the tumor, and (3) contraindications for PTCD due to massive ascites and risk of self-tube removal. Compared with PTCD, metallic stent placement can be used in EUS-HGS in primary session. Therefore, EUS-HGS may be indicated even if a small amount of ascites is present in the access route. However, if massive ascites is present, preventing the formation of fistula between the stomach and liver, EUS-HGS is not indicated. The contraindications for EUS-HGS are the following: (1) massive ascites between the stomach and liver and (2) unresectable gastric cancer.

#### *2.2.2 Technical tips*

The EUS device is introduced into the stomach. Then, using counterclockwise rotation, the left hepatic lobe can be identified. A 19-G FNA needle may be better than a 22-G. A stiffer guidewire is inserted into the biliary tract through the EUS-fine needle aspiration (FNA) needle because fistula dilation is an important point to insert the stent delivery system compared with EUS-CDS. If segment 2 (B2) is punctured, because devices can be passed across the mediastinum, when puncturing from the esophagus, severe adverse events such as mediastinitis or pneumomediastinum may occur. Therefore, segment 3 (B3) should be initially punctured. There are two important points regarding the intrahepatic bile duct puncture. The first point is the angle of the bile duct, and the second point is the volume of the liver parenchyma. The bile duct that runs from the upper left to the lower right based on EUS imaging should be punctured to advance the guidewire toward the hepatic hilum. Furthermore, avoiding stent migration into the abdominal cavity requires a sufficient volume of liver parenchyma to obtain anchoring function, like PTCD procedure**.** Therefore, B3 is better as puncturing site. The next step is guidewire insertion. During EUS-HGS, one of the most important procedures is the guidewire insertion. If the guidewire is introduced into the peripheral biliary tract, the next step may not be attempted. The biliary tract running from the upper left to the lower right on EUS imaging should be punctured to successfully advance the guidewire toward the hepatic hilum, as described in the above section. If the guidewire is advanced into the periphery of the biliary tract, the guidewire should be pulled, and then advance of the guidewire into the hepatic hilum should be attempted. However, during this procedure, the guidewire is sometimes kinked with the FNA needle. To avoid this adverse event, the liver impaction method appears clinically impactful [15]. Various types of guidewire are available. A 0.025-inch guidewire with a highly flexible tip, sufficient stiffness, and easy seeking ability is preferable for EUS-guided procedures. After the guidewire is inserted along with other devices, continued visualization of the other devices on EUS imaging is important during various EUS-guided procedures to fit the alignment. To perform stent deployment, the bile duct and stomach wall must be dilated. Various techniques for dilating a fistula have been reported to date [16–20]. A graded dilation technique using a dilator or a 4-mm balloon catheter is used by many authors according to previous studies. The mechanical dilator (6 to 10 Fr), balloon catheter (4–8 mm), and needle knife are mainly selected by many authors. Park et al. [16] described that, among the total of 57 patients who underwent EUS-BD, post-procedural adverse events such as bile peritonitis (n = 2), mild bleeding (n = 2), and self-limited pneumoperitoneum (n = 7) were observed. According to multivariate analysis, the use of a needle knife was the only risk factor for post-procedure adverse events of EUS-BD (P = 0.01, HR 12.4, 95%CI, 1.83– 83.5). Therefore, their conclusion is that a needle knife should not be selected as a dilation device. To avoid this risk, an electrocautery dilator, which was coaxial with the guidewire, has been developed. Although this device is clinically useful as a dilation device, this device has disadvantages such as burning effect. When the bile duct is punctured while avoiding small vessels using color Doppler, bleeding can occur due to the burning effect of the electrocautery dilator. To reduce burning effects, a novel electrocautery dilator has become available in Japan (Fine 025; Medico's Hirata Inc., Japan, Osaka) [17]. Further study is needed to evaluate this device. On the other hand, a graded dilation technique using a balloon or mechanical dilator may be safe because burning effect does not occur. Park et al. [18] reported that graded dilation using a 4-Fr catheter and 6- or 7-Fr bougie dilator device is safe. In this study, technical success rate of EUS-CDS was high, with a low rate of adverse events. According to our previous report [19], we reported successful EUS-HGS using an ERCP catheter and a 4-mm balloon catheter without using electrocautery devices. This technique may be associated with a lower frequency of bleeding caused by the burning, although bile leakage might easily occur during graded dilation because procedure time is longer. Recently, novel techniques and dilation devices for EUS-BD have been reported. Paik et al. [20] reported a simplified fistula dilation technique. After the biliary tract was punctured using a 19-G FNA needle, direct insertion using a 4-mm balloon catheter was performed. In 28 patients, the technical success rate was 96% (27/28). In addition, early adverse events were not seen in any patients. We also described a simplified fistula dilation technique using a fine-gauge balloon catheter [21, 22]. As an even more novel technique, a one-step stent placement technique has been described [23]. According to this study, 32 patients, who were complicated with malignant biliary stricture, were enrolled. EUS-BD was performed using a novel metallic stent. The introducer for this novel stent has only a 3-Fr-tip-4-Fr tapered. The technical success rate of one-step stent deployment was 88% (14/16). In addition, the procedure time was short in the one-step stent placement group. The risk of bile

**65**

(**Figures 4**–**6**).

*EUS-Guided Biliary Drainage*

*DOI: http://dx.doi.org/10.5772/intechopen.87970*

leakage may be increased, if procedure time is longer. In fact, in their reports, although significant differences were not seen, early adverse events were uncommon in the one-step dilation group compared with the graded dilation group (31.3% vs. 6.3%, P = 0.172). Although randomized, clinical trials and additional cases are needed to clarify which dilation technique or devices are more suitable in EUS-HGS, these techniques have potentials of decreasing the frequency of adverse events such as bile leakage. The final step is stent deployment. A fully covered self-expanding metal stent (FCSEMS) with strong radial force may be suitable for EUS-HGS compared with a plastic stent for the following reasons: (1) if a large fistula is created before inserting the stent delivery system, bile leakage from the gap between the stent and fistula the fistula is less likely; (2) longer stent patency may be obtained due to large diameter compared with plastic stent; and (3) a tamponade effect of stent expansion may occur if bleeding from the stomach wall is present. However, the following disadvantages are seen for FCSEMS: (1) the stent is expensive; (2) stent shortening must be considered during stent deployment, especially in the luminal portion to prevent stent migration into the abdominal cavity; and (3) side branches may be obstructed by covered site of the metal stent [24]. A novel metallic stent and several efforts to prevent stent migration have been recently reported. Some authors have described that a double-pigtail plastic stent can be placed inside the metal stent, when standard metallic stents are used. Prevention of stent dislocation requires sufficient stent length. We have also described that EUS-HGS can be safely performed using a partially covered metallic stent with long length [25]. More recently, Song et al. [26] described a preliminary study on a newly hybrid metal stent in EUS-BD procedure. The distal portion of this stent, which is 3.5-mm long, comprises silicone-covered nitinol wire to prevent bile leakage through the mesh. Also, anti-migration flaps are present proximal and distal to the covered site to prevent stent migration into the abdominal cavity. This novel stent, on the proximal site, has the uncovered site. This uncovered site is 1.5- to 5.5-mm long. This fact can prevent bile duct branch obstruction. In their study using this novel hybrid stent, EUS-HGS was successfully attempted for all 10 patients. In addition, no bile leakage or stent migration was seen in any patients. On the other hand, EUS-HGS using a newly designed plastic stent has been described by Umeda and Itoi et al. [27] that report using an 8-Fr single-pigtail plastic stent, which is a push-type stent that is usually not possible to retract (total length, 20 cm; effective length, 15 cm; four flanges). Also, the proximal end has a pigtail structure, and the distal end is strongly tapered. EUS-HGS using this plastic stent was successfully attempted in all 23 patients. Although bleeding or abdominal pain was seen in four patients (17.4%), no severe adverse events such as stent migration into the abdominal cavity or stent dislocation were observed during follow-up (median 5.0 months). Median stent patency was 4.0 months, and therefore, this result was clinically encouraging. However, as the author described in this report, additional long-term studies with a larger number of cases are needed to clarify the clinical benefit of using this stent for EUS-HGS. To prevent stent migration, technical tips for stent deployment are also extremely important. One of the consensus techniques in Japan is the intra-scope channel release technique [28]. The following steps were followed for stent release under the intrascope channel technique. The stent delivery system was inserted into the

confluence of B2 and B3. Next, stent release was performed from the intrahepatic bile duct to the hepatic parenchyma. Thereafter, the EUS scope was stabilized until the stent was deployed up to 1 cm within the EUS scope. The EUS scope was then withdrawn slightly while simultaneously pushing the stent delivery system. In that procedure, stent release was performed completely under endoscopic guidance

#### *EUS-Guided Biliary Drainage DOI: http://dx.doi.org/10.5772/intechopen.87970*

*Advanced Endoscopy*

step is guidewire insertion. During EUS-HGS, one of the most important procedures is the guidewire insertion. If the guidewire is introduced into the peripheral biliary tract, the next step may not be attempted. The biliary tract running from the upper left to the lower right on EUS imaging should be punctured to successfully advance the guidewire toward the hepatic hilum, as described in the above section. If the guidewire is advanced into the periphery of the biliary tract, the guidewire should be pulled, and then advance of the guidewire into the hepatic hilum should be attempted. However, during this procedure, the guidewire is sometimes kinked with the FNA needle. To avoid this adverse event, the liver impaction method appears clinically impactful [15]. Various types of guidewire are available. A 0.025-inch guidewire with a highly flexible tip, sufficient stiffness, and easy seeking ability is preferable for EUS-guided procedures. After the guidewire is inserted along with other devices, continued visualization of the other devices on EUS imaging is important during various EUS-guided procedures to fit the alignment. To perform stent deployment, the bile duct and stomach wall must be dilated. Various techniques for dilating a fistula have been reported to date [16–20]. A graded dilation technique using a dilator or a 4-mm balloon catheter is used by many authors according to previous studies. The mechanical dilator (6 to 10 Fr), balloon catheter (4–8 mm), and needle knife are mainly selected by many authors. Park et al. [16] described that, among the total of 57 patients who underwent EUS-BD, post-procedural adverse events such as bile peritonitis (n = 2), mild bleeding (n = 2), and self-limited pneumoperitoneum (n = 7) were observed. According to multivariate analysis, the use of a needle knife was the only risk factor for post-procedure adverse events of EUS-BD (P = 0.01, HR 12.4, 95%CI, 1.83– 83.5). Therefore, their conclusion is that a needle knife should not be selected as a dilation device. To avoid this risk, an electrocautery dilator, which was coaxial with the guidewire, has been developed. Although this device is clinically useful as a dilation device, this device has disadvantages such as burning effect. When the bile duct is punctured while avoiding small vessels using color Doppler, bleeding can occur due to the burning effect of the electrocautery dilator. To reduce burning effects, a novel electrocautery dilator has become available in Japan (Fine 025; Medico's Hirata Inc., Japan, Osaka) [17]. Further study is needed to evaluate this device. On the other hand, a graded dilation technique using a balloon or mechanical dilator may be safe because burning effect does not occur. Park et al. [18] reported that graded dilation using a 4-Fr catheter and 6- or 7-Fr bougie dilator device is safe. In this study, technical success rate of EUS-CDS was high, with a low rate of adverse events. According to our previous report [19], we reported successful EUS-HGS using an ERCP catheter and a 4-mm balloon catheter without using electrocautery devices. This technique may be associated with a lower frequency of bleeding caused by the burning, although bile leakage might easily occur during graded dilation because procedure time is longer. Recently, novel techniques and dilation devices for EUS-BD have been reported. Paik et al. [20] reported a simplified fistula dilation technique. After the biliary tract was punctured using a 19-G FNA needle, direct insertion using a 4-mm balloon catheter was performed. In 28 patients, the technical success rate was 96% (27/28). In addition, early adverse events were not seen in any patients. We also described a simplified fistula dilation technique using a fine-gauge balloon catheter [21, 22]. As an even more novel technique, a one-step stent placement technique has been described [23].

According to this study, 32 patients, who were complicated with malignant biliary stricture, were enrolled. EUS-BD was performed using a novel metallic stent. The introducer for this novel stent has only a 3-Fr-tip-4-Fr tapered. The technical success rate of one-step stent deployment was 88% (14/16). In addition, the procedure time was short in the one-step stent placement group. The risk of bile

**64**

leakage may be increased, if procedure time is longer. In fact, in their reports, although significant differences were not seen, early adverse events were uncommon in the one-step dilation group compared with the graded dilation group (31.3% vs. 6.3%, P = 0.172). Although randomized, clinical trials and additional cases are needed to clarify which dilation technique or devices are more suitable in EUS-HGS, these techniques have potentials of decreasing the frequency of adverse events such as bile leakage. The final step is stent deployment. A fully covered self-expanding metal stent (FCSEMS) with strong radial force may be suitable for EUS-HGS compared with a plastic stent for the following reasons: (1) if a large fistula is created before inserting the stent delivery system, bile leakage from the gap between the stent and fistula the fistula is less likely; (2) longer stent patency may be obtained due to large diameter compared with plastic stent; and (3) a tamponade effect of stent expansion may occur if bleeding from the stomach wall is present. However, the following disadvantages are seen for FCSEMS: (1) the stent is expensive; (2) stent shortening must be considered during stent deployment, especially in the luminal portion to prevent stent migration into the abdominal cavity; and (3) side branches may be obstructed by covered site of the metal stent [24]. A novel metallic stent and several efforts to prevent stent migration have been recently reported. Some authors have described that a double-pigtail plastic stent can be placed inside the metal stent, when standard metallic stents are used. Prevention of stent dislocation requires sufficient stent length. We have also described that EUS-HGS can be safely performed using a partially covered metallic stent with long length [25]. More recently, Song et al. [26] described a preliminary study on a newly hybrid metal stent in EUS-BD procedure. The distal portion of this stent, which is 3.5-mm long, comprises silicone-covered nitinol wire to prevent bile leakage through the mesh. Also, anti-migration flaps are present proximal and distal to the covered site to prevent stent migration into the abdominal cavity. This novel stent, on the proximal site, has the uncovered site. This uncovered site is 1.5- to 5.5-mm long. This fact can prevent bile duct branch obstruction. In their study using this novel hybrid stent, EUS-HGS was successfully attempted for all 10 patients. In addition, no bile leakage or stent migration was seen in any patients. On the other hand, EUS-HGS using a newly designed plastic stent has been described by Umeda and Itoi et al. [27] that report using an 8-Fr single-pigtail plastic stent, which is a push-type stent that is usually not possible to retract (total length, 20 cm; effective length, 15 cm; four flanges). Also, the proximal end has a pigtail structure, and the distal end is strongly tapered. EUS-HGS using this plastic stent was successfully attempted in all 23 patients. Although bleeding or abdominal pain was seen in four patients (17.4%), no severe adverse events such as stent migration into the abdominal cavity or stent dislocation were observed during follow-up (median 5.0 months). Median stent patency was 4.0 months, and therefore, this result was clinically encouraging. However, as the author described in this report, additional long-term studies with a larger number of cases are needed to clarify the clinical benefit of using this stent for EUS-HGS. To prevent stent migration, technical tips for stent deployment are also extremely important. One of the consensus techniques in Japan is the intra-scope channel release technique [28]. The following steps were followed for stent release under the intrascope channel technique. The stent delivery system was inserted into the confluence of B2 and B3. Next, stent release was performed from the intrahepatic bile duct to the hepatic parenchyma. Thereafter, the EUS scope was stabilized until the stent was deployed up to 1 cm within the EUS scope. The EUS scope was then withdrawn slightly while simultaneously pushing the stent delivery system. In that procedure, stent release was performed completely under endoscopic guidance (**Figures 4**–**6**).

**Figure 4.** *The intrahepatic bile duct is punctured using 19-G needle from the stomach.*

#### **Figure 5.**

*The covered metal stent deployment is performed from the intrahepatic bile duct to the stomach.*

**Figure 6.** *The metal stent is placed in the stomach.*

#### *2.2.3 Clinical results*

According to a recent meta-analysis of 686 patients [29], overall clinical success and technical success rates were, respectively, 84% (95%CI 80–88%) and 96% (95%CI, 93–98%) for EUS-HGS. On the other hand, in terms of technical results for EUS-HGS conducted by non-expert hands, the technical success rate was only 64.7% (22/34) [30]. This technique should therefore be performed in expert-assisted situations, and improvement of devices is warranted. The rate of adverse events including bile leakage, stent migration, bleeding, and peritonitis was relatively high (29%).

**67**

*EUS-Guided Biliary Drainage*

*2.3.1 Indications*

or HGS [31].

*2.3.2 Technical tips*

*DOI: http://dx.doi.org/10.5772/intechopen.87970*

**2.3 EUS-guided gallbladder drainage (GBD)**

Compared with percutaneous transhepatic gallbladder drainage (PTGBD), one of the advantages of EUS-GBD is internal drainage. In addition, the procedure is technically simple compared with endoscopic retrograde gallbladder drainage (ETGBD). However, the results of long-term follow-up remain unclear, and there is still insufficient evidence on the performance of EUS-GBD as the first-line drainage technique. Current indications for EUS-GBD are thus as follows: (1) nonsurgical candidates with/without stone extraction, (2) as a bridge to surgical cholecystectomy, (3) conversion from PTGBD to EUS-GBD, (4) alternative to failed PTGBD/ ETGBD, and (5) alternative to failed EUS-guided biliary drainage such as EUS-CDS

The EUS probe is advanced into the stomach or duodenum to identify the gallbladder. The gallbladder neck is normally detected from the duodenal bulb, and the body or tail of the gallbladder is also detected via the stomach. No evidence of clinical differences between the use of these two sites has been found in previous reports. Tyberg et al. conducted a clinical study of differences between transgastric and transduodenal approaches regarding EUS-GBD [32]. In this study including a total of 42 patients, technical success was achieved in 92.6% (25/27) in transgastric approach group and in 100% in the transduodenal approach group. Adverse events were observed in four patients in the transgastric approach group (14.8%) and in five patients in the transduodenal approach group (33%). Therefore, they concluded that stent location was not a significant predictor of clinical failure (P = 0.432) or adverse events (P = 0.289). Also, Teoh et al. performed a comparative analysis of EUS-GBD from the antrum route or duodenum route [31]. Among a total of 59 patients, technical and clinical success rates were 94.4% (34/36) and 91.2% (31/34), respectively, among patients who underwent EUS-GBD from the antrum and 100% (23/23) and 95.7% (22/23) among patients who underwent EUS-GBD from the duodenum (P = 0.52 and 0.39). Overall adverse events also showed no significant difference between the two groups (P = 0.64). Endoscopists are thus free to select the site preferred for puncture. However, the duodenum may have less mobility compared with the stomach. This may result in less technically challenging and lower risks of both early and late stent migration with the transduodenal route. In addition, the frequency of food reflux into the gallbladder through the EUS-GBD stent may be lower when puncture is attempted via the duodenum compared with the stomach [33, 34]. On the other hand, EUS-GBD from the stomach may have several benefits. First, because the lumen is normally larger in the gallbladder body than in the gallbladder neck, puncturing the gallbladder through the stomach may be easy. In particular, the gallbladder body allows a greater lumen area to accommodate the internal flanges of the LAMS. Second, if serious complications such as perforation or stent migration occur, the consequences may be less serious because subsequent surgery is easier in patients who have undergone EUS-GBD from the stomach compared with from the duodenum. Endoscopists should thus be mindful of the characteristics of each site before performing EUS-GBD (**Figures 7** and **8**). The next step is fistula dilation. According to previous reports [33, 35–42], a 6 or 7-Fr bougie, tapered catheter, and 4-mm balloon were the most commonly used devices for dilatation prior to insertion of drainage devices. If some resistance to passage of the stent delivery system is present, electrocautery dilation may be useful

#### **2.3 EUS-guided gallbladder drainage (GBD)**

#### *2.3.1 Indications*

*Advanced Endoscopy*

**66**

*2.2.3 Clinical results*

*The metal stent is placed in the stomach.*

**Figure 6.**

**Figure 5.**

**Figure 4.**

According to a recent meta-analysis of 686 patients [29], overall clinical success

and technical success rates were, respectively, 84% (95%CI 80–88%) and 96% (95%CI, 93–98%) for EUS-HGS. On the other hand, in terms of technical results for EUS-HGS conducted by non-expert hands, the technical success rate was only 64.7% (22/34) [30]. This technique should therefore be performed in expert-assisted situations, and improvement of devices is warranted. The rate of adverse events including bile leakage, stent migration, bleeding, and peritonitis was relatively high (29%).

*The covered metal stent deployment is performed from the intrahepatic bile duct to the stomach.*

*The intrahepatic bile duct is punctured using 19-G needle from the stomach.*

Compared with percutaneous transhepatic gallbladder drainage (PTGBD), one of the advantages of EUS-GBD is internal drainage. In addition, the procedure is technically simple compared with endoscopic retrograde gallbladder drainage (ETGBD). However, the results of long-term follow-up remain unclear, and there is still insufficient evidence on the performance of EUS-GBD as the first-line drainage technique. Current indications for EUS-GBD are thus as follows: (1) nonsurgical candidates with/without stone extraction, (2) as a bridge to surgical cholecystectomy, (3) conversion from PTGBD to EUS-GBD, (4) alternative to failed PTGBD/ ETGBD, and (5) alternative to failed EUS-guided biliary drainage such as EUS-CDS or HGS [31].

#### *2.3.2 Technical tips*

The EUS probe is advanced into the stomach or duodenum to identify the gallbladder. The gallbladder neck is normally detected from the duodenal bulb, and the body or tail of the gallbladder is also detected via the stomach. No evidence of clinical differences between the use of these two sites has been found in previous reports. Tyberg et al. conducted a clinical study of differences between transgastric and transduodenal approaches regarding EUS-GBD [32]. In this study including a total of 42 patients, technical success was achieved in 92.6% (25/27) in transgastric approach group and in 100% in the transduodenal approach group. Adverse events were observed in four patients in the transgastric approach group (14.8%) and in five patients in the transduodenal approach group (33%). Therefore, they concluded that stent location was not a significant predictor of clinical failure (P = 0.432) or adverse events (P = 0.289). Also, Teoh et al. performed a comparative analysis of EUS-GBD from the antrum route or duodenum route [31]. Among a total of 59 patients, technical and clinical success rates were 94.4% (34/36) and 91.2% (31/34), respectively, among patients who underwent EUS-GBD from the antrum and 100% (23/23) and 95.7% (22/23) among patients who underwent EUS-GBD from the duodenum (P = 0.52 and 0.39). Overall adverse events also showed no significant difference between the two groups (P = 0.64). Endoscopists are thus free to select the site preferred for puncture. However, the duodenum may have less mobility compared with the stomach. This may result in less technically challenging and lower risks of both early and late stent migration with the transduodenal route. In addition, the frequency of food reflux into the gallbladder through the EUS-GBD stent may be lower when puncture is attempted via the duodenum compared with the stomach [33, 34]. On the other hand, EUS-GBD from the stomach may have several benefits. First, because the lumen is normally larger in the gallbladder body than in the gallbladder neck, puncturing the gallbladder through the stomach may be easy. In particular, the gallbladder body allows a greater lumen area to accommodate the internal flanges of the LAMS. Second, if serious complications such as perforation or stent migration occur, the consequences may be less serious because subsequent surgery is easier in patients who have undergone EUS-GBD from the stomach compared with from the duodenum. Endoscopists should thus be mindful of the characteristics of each site before performing EUS-GBD (**Figures 7** and **8**).

The next step is fistula dilation. According to previous reports [33, 35–42], a 6 or 7-Fr bougie, tapered catheter, and 4-mm balloon were the most commonly used devices for dilatation prior to insertion of drainage devices. If some resistance to passage of the stent delivery system is present, electrocautery dilation may be useful

#### *Advanced Endoscopy*

**Figure 7.** *The gallbladder is punctured using 19-G needle from the duodenum.*

according to previous reports. Bile leakage may occur as with other EUS-BD procedures, after this step and prior to stent deployment. In fact, the risk of bile leakage is frequently observed compared with EUS-HGS, because of the lack of a tamponade effect from the liver. As a result, dilation with one-step process may be preferred. Electrocautery dilation can certainly be performed regarding dilation of the fistula; however, it carries a risk of burns, which can in turn lead to bleeding. A dilation technique using a fine-gauge balloon catheter may be suitable from the perspective of preventing adverse events. However, since no evidence suggests which dilation devices should be used, a randomized controlled study among various dilation devices should be attempted.

Recently, the hot AXIOS stent with electrocautery-enhanced delivery system (Boston Scientific, Marlborough, MA, USA) has been developed. This stent is a through-the-scope LAMS mounted on a stent delivery system with an electrocautery wire at the distal tip. The electrocautery tip allows passage of the catheter into the gallbladder without the need for prior dilation of the tract by application of a pure cutting current. This fact may have clinical benefits, such as shortening of

**69**

*EUS-Guided Biliary Drainage*

*DOI: http://dx.doi.org/10.5772/intechopen.87970*

the procedure time, reduced bile leakage during fistula dilation, and an improved technical success rate due to the single-step nature of the procedure. However, a previous retrospective study [31] showed no significant differences in technical success rates between hot and cold AXIOS [100% (10/10) vs. 95.9% (47/49), respectively; P = 1.00]. In addition, rates of adverse events were not significantly different [20% (2/10) vs. 34.7% (17/49), respectively; P = 0.48]. Since electrocautery dilation procedures may carry a risk of bleeding due to the potential for burns, a random-

The next step is stent deployment. EUS-GBD has been performed using plastic stents. However, because stent deployment in EUS-GBD is performed from the gallbladder to the stomach or duodenum through the abdominal cavity, no tamponade effect arises such as due to the hepatic parenchyma, as seen with EUS-HGS. Bile leakage can therefore occur due to the gap between the fistula and plastic stent. In addition, stent patency is shorter compared with the covered SEMS (cSEMS). Jang et al. reported a comparative trial between EUS-GBD and PTGBD for acute cholecystitis [38]. In a study including 29 patients, who underwent EUS-GBD, laparoscopic cholecystectomy was performed in 23 patients (79.3%). None of the patients initially underwent open cholecystectomy, although 2 of the 23 patients (8.7%) in the EUS-GBD group and 3 of 26 patients (11.5%) in the PTGBD group required conversion to open cholecystectomy (P = 0.99). They also described that EUS-GBD did not cause severe inflammation or adhesions to the tissues surrounding the gallbladder and laparoscopic cholecystectomy could be safely attempted following EUS-GBD using plastic stents or endoscopic naso-gallbladder drainage (ENGBD) without an increase in technical difficulty as compared with PTGBD. Therefore, the use of a plastic stent should first be considered, if the patient is likely to undergo cholecystectomy in the future. Recently, cSEMS has been used as the drainage device for EUS-GBD instead of plastic stents in patients who are not good candidates for surgery due to other severe organ failure or the presence of advanced malignancy. The cSEMS is useful as compared with plastic stents, since self-expanding stents prevent bile leakage and are associated with longer stent patency. However, because of weak flanges, the standard tubular cSEMS has a risk of stent migration after stent deployment. As a method to prevent stent migration, several authors have described combination usage of a double-pigtail plastic stent or ENGBD and cSEMS [33, 39, 40, 42]. Indeed, stent migration has not been observed in EUS-GBD cases using this technique. And if the cSEMS migrates, the pigtail plastic stent remains in place from the gallbladder to the gastrointestinal lumen.

ized controlled trial is needed to determine the superiority of hot AXIOS.

This maintains fistula patency, allowing re-intervention.

might be preferable to prevent adverse events.

Khan et al. undertook a systematic review of endoscopic gallbladder drainage [43]. In this review, subgroup analysis was attempted regarding the kinds of stent in the EUS-GBD. According to their results, EUS-GBD using SEMS is less likely to cause adverse events than EUS-GBD using a plastic stent or ENGBD. Therefore, if the patient is unlikely to undergo future cholecystectomy, EUS-GBD using SEMS

LAMS deployment has been reported in EUS-guided transluminal interventions, including EUS-guided pancreatic fluid collection [44], EUS-guided bile duct drainage [45], and EUS-guided gastroenterostomy [46]. LAMS has several benefits compared with SEMS. LAMS has a larger inner diameter, allowing better drainage. Also, the unique design such as the form of anchoring flanges may play an important role in preventing stent migration into both abdominal and luminal portions. Finally, a standard endoscope can be passed into the gallbladder lumen through the LAMS after LAMS deployment. In cases requiring EUS-guided intervention for walled-off necrosis [47], the use of SEMS or LAMS is superior to plastic stents in terms of overall treatment efficacy. The number of procedures required was

#### *EUS-Guided Biliary Drainage DOI: http://dx.doi.org/10.5772/intechopen.87970*

*Advanced Endoscopy*

**68**

**Figure 8.**

**Figure 7.**

devices should be attempted.

according to previous reports. Bile leakage may occur as with other EUS-BD procedures, after this step and prior to stent deployment. In fact, the risk of bile leakage is frequently observed compared with EUS-HGS, because of the lack of a tamponade effect from the liver. As a result, dilation with one-step process may be preferred. Electrocautery dilation can certainly be performed regarding dilation of the fistula; however, it carries a risk of burns, which can in turn lead to bleeding. A dilation technique using a fine-gauge balloon catheter may be suitable from the perspective of preventing adverse events. However, since no evidence suggests which dilation devices should be used, a randomized controlled study among various dilation

*The covered metal stent deployment is performed from the gallbladder to the duodenum.*

*The gallbladder is punctured using 19-G needle from the duodenum.*

Recently, the hot AXIOS stent with electrocautery-enhanced delivery system (Boston Scientific, Marlborough, MA, USA) has been developed. This stent is a through-the-scope LAMS mounted on a stent delivery system with an electrocautery wire at the distal tip. The electrocautery tip allows passage of the catheter into the gallbladder without the need for prior dilation of the tract by application of a pure cutting current. This fact may have clinical benefits, such as shortening of

the procedure time, reduced bile leakage during fistula dilation, and an improved technical success rate due to the single-step nature of the procedure. However, a previous retrospective study [31] showed no significant differences in technical success rates between hot and cold AXIOS [100% (10/10) vs. 95.9% (47/49), respectively; P = 1.00]. In addition, rates of adverse events were not significantly different [20% (2/10) vs. 34.7% (17/49), respectively; P = 0.48]. Since electrocautery dilation procedures may carry a risk of bleeding due to the potential for burns, a randomized controlled trial is needed to determine the superiority of hot AXIOS.

The next step is stent deployment. EUS-GBD has been performed using plastic stents. However, because stent deployment in EUS-GBD is performed from the gallbladder to the stomach or duodenum through the abdominal cavity, no tamponade effect arises such as due to the hepatic parenchyma, as seen with EUS-HGS. Bile leakage can therefore occur due to the gap between the fistula and plastic stent. In addition, stent patency is shorter compared with the covered SEMS (cSEMS). Jang et al. reported a comparative trial between EUS-GBD and PTGBD for acute cholecystitis [38]. In a study including 29 patients, who underwent EUS-GBD, laparoscopic cholecystectomy was performed in 23 patients (79.3%). None of the patients initially underwent open cholecystectomy, although 2 of the 23 patients (8.7%) in the EUS-GBD group and 3 of 26 patients (11.5%) in the PTGBD group required conversion to open cholecystectomy (P = 0.99). They also described that EUS-GBD did not cause severe inflammation or adhesions to the tissues surrounding the gallbladder and laparoscopic cholecystectomy could be safely attempted following EUS-GBD using plastic stents or endoscopic naso-gallbladder drainage (ENGBD) without an increase in technical difficulty as compared with PTGBD. Therefore, the use of a plastic stent should first be considered, if the patient is likely to undergo cholecystectomy in the future. Recently, cSEMS has been used as the drainage device for EUS-GBD instead of plastic stents in patients who are not good candidates for surgery due to other severe organ failure or the presence of advanced malignancy. The cSEMS is useful as compared with plastic stents, since self-expanding stents prevent bile leakage and are associated with longer stent patency. However, because of weak flanges, the standard tubular cSEMS has a risk of stent migration after stent deployment. As a method to prevent stent migration, several authors have described combination usage of a double-pigtail plastic stent or ENGBD and cSEMS [33, 39, 40, 42]. Indeed, stent migration has not been observed in EUS-GBD cases using this technique. And if the cSEMS migrates, the pigtail plastic stent remains in place from the gallbladder to the gastrointestinal lumen. This maintains fistula patency, allowing re-intervention.

Khan et al. undertook a systematic review of endoscopic gallbladder drainage [43]. In this review, subgroup analysis was attempted regarding the kinds of stent in the EUS-GBD. According to their results, EUS-GBD using SEMS is less likely to cause adverse events than EUS-GBD using a plastic stent or ENGBD. Therefore, if the patient is unlikely to undergo future cholecystectomy, EUS-GBD using SEMS might be preferable to prevent adverse events.

LAMS deployment has been reported in EUS-guided transluminal interventions, including EUS-guided pancreatic fluid collection [44], EUS-guided bile duct drainage [45], and EUS-guided gastroenterostomy [46]. LAMS has several benefits compared with SEMS. LAMS has a larger inner diameter, allowing better drainage. Also, the unique design such as the form of anchoring flanges may play an important role in preventing stent migration into both abdominal and luminal portions. Finally, a standard endoscope can be passed into the gallbladder lumen through the LAMS after LAMS deployment. In cases requiring EUS-guided intervention for walled-off necrosis [47], the use of SEMS or LAMS is superior to plastic stents in terms of overall treatment efficacy. The number of procedures required was

#### *Advanced Endoscopy*

significantly lower with LAMS compared with SEMS or plastic stent placement. However, since high-quality evidence is lacking regarding the use of LAMS in EUS-GBD procedures, comparative studies between LAMS and other drainage devices for EUS-GBD are needed.

Finally, this chapter referred to our previous papers [48–50].

### **3. Conclusions**

EUS-guided biliary drainage has clinical impact as alternative drainage technique. If more evidences are available, indications of this technique will be spread.

## **Conflict of interest**

The authors declare no conflict of interest.

### **Author details**

Takeshi Ogura\* and Kazuhide Higuchi 2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan

\*Address all correspondence to: oguratakeshi0411@yahoo.co.jp

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

**71**

*EUS-Guided Biliary Drainage*

**References**

2018;**6**:E67-E72

2011;**106**:1239-1245

2018;**88**:277-282

2016;**83**:834-845

Endoscopy. 2018;**88**:9-17

*DOI: http://dx.doi.org/10.5772/intechopen.87970*

[8] Itoi T, Binmoeller KF, Shah J, et al. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointestinal Endoscopy. 2012;**75**:870-876

[9] Fabbri C, Fugazza A, Binda C, et al. Beyond palliation: Using EUS-guided choledochoduodenostomy with a lumen-apposing metal stent as a bride to surgery. A case series. Journal of Gastrointestinal and Liver Diseases.

[10] Anderloni A, Fugazza A, Troncone E, et al. Single-step EUS-guided

choledochoduodenostomy using a lumenapposing metal stent for malignant biliary obstruction. Gastrointestinal

2019;**28**:125-128

Endoscopy. 2019;**89**:69-76

2019;**53**:243-2250

2013;**78**:374-380

2015;**47**:72-75

[11] Mohan BP, Shakhatreh M, Garg R, et al. Efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy: A

systematic review and meta-analysis. Journal of Clinical Gastroenterology.

[12] Park SJ, Choi JH, Park do H, et al. Expanding indication: EUS-guided hepaticoduodenostomy for isolated right intrahepatic bile duct obstruction (with video). Gastrointestinal Endoscopy.

[13] Ogura T, Sno T, Onda S, et al. Endoscopic ultrasound-guided biliary drainage for right intrahepatic bile duct obstruction (with video). Endoscopy.

[14] Khashab MA, Valeshabad AK, Kalloo AN, et al. A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Digestive Diseases and Sciences. 2015;**60**:557-565

[1] Rai P, Lokesh CR, Goel A, et al. Endoscopic ultrasound-guided choledochoduodenostomy using partially-covered self-expandable metal stent in patients with malignant distal biliary obstruction and unsuccessful ERCP. Endoscopy International Open.

[2] Hara K, Yamao K, Niwa Y, et al. Prospective clinical study of EUSguided choledochoduodenostomy for malignant lower biliary obstruction. The American Journal of Gastroenterology.

[3] Park JK, Woo YS, Noh DH, et al. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: Prospective randomized controlled study. Gastrointestinal Endoscopy.

[4] Bang JY, Navaneethan U, Hasan M, et al. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: A randomized trial (with videos). Gastrointestinal

[5] Ogura T, Masuda D, Takeuchi T, et al. Intraluminal water filling technique to prevent double mucosal puncture during EUSguided choledochoduodenostomy. Gastrointestinal Endoscopy.

[6] Kawakami H, Kuwatani M,

and Liver. 2016;**10**:318-319

Sakamoto N. Double penetrated double wall during endoscopic ultrasoundguided choledochoduodenostomy. Gut

[7] Park DH. Jang JW, Lee SS, et al. EUS-guided biliary drainage with transluminal stenting after failed ERCP: Predictors of adverse events and long-term results. Gastrointestinal

Endoscopy. 2011;**74**:1276-1284

### **References**

*Advanced Endoscopy*

**3. Conclusions**

**Conflict of interest**

The authors declare no conflict of interest.

for EUS-GBD are needed.

**70**

**Author details**

Takeshi Ogura\* and Kazuhide Higuchi

provided the original work is properly cited.

2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium,

significantly lower with LAMS compared with SEMS or plastic stent placement. However, since high-quality evidence is lacking regarding the use of LAMS in EUS-GBD procedures, comparative studies between LAMS and other drainage devices

EUS-guided biliary drainage has clinical impact as alternative drainage technique. If more evidences are available, indications of this technique will be spread.

Finally, this chapter referred to our previous papers [48–50].

\*Address all correspondence to: oguratakeshi0411@yahoo.co.jp

[1] Rai P, Lokesh CR, Goel A, et al. Endoscopic ultrasound-guided choledochoduodenostomy using partially-covered self-expandable metal stent in patients with malignant distal biliary obstruction and unsuccessful ERCP. Endoscopy International Open. 2018;**6**:E67-E72

[2] Hara K, Yamao K, Niwa Y, et al. Prospective clinical study of EUSguided choledochoduodenostomy for malignant lower biliary obstruction. The American Journal of Gastroenterology. 2011;**106**:1239-1245

[3] Park JK, Woo YS, Noh DH, et al. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: Prospective randomized controlled study. Gastrointestinal Endoscopy. 2018;**88**:277-282

[4] Bang JY, Navaneethan U, Hasan M, et al. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: A randomized trial (with videos). Gastrointestinal Endoscopy. 2018;**88**:9-17

[5] Ogura T, Masuda D, Takeuchi T, et al. Intraluminal water filling technique to prevent double mucosal puncture during EUSguided choledochoduodenostomy. Gastrointestinal Endoscopy. 2016;**83**:834-845

[6] Kawakami H, Kuwatani M, Sakamoto N. Double penetrated double wall during endoscopic ultrasoundguided choledochoduodenostomy. Gut and Liver. 2016;**10**:318-319

[7] Park DH. Jang JW, Lee SS, et al. EUS-guided biliary drainage with transluminal stenting after failed ERCP: Predictors of adverse events and long-term results. Gastrointestinal Endoscopy. 2011;**74**:1276-1284

[8] Itoi T, Binmoeller KF, Shah J, et al. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointestinal Endoscopy. 2012;**75**:870-876

[9] Fabbri C, Fugazza A, Binda C, et al. Beyond palliation: Using EUS-guided choledochoduodenostomy with a lumen-apposing metal stent as a bride to surgery. A case series. Journal of Gastrointestinal and Liver Diseases. 2019;**28**:125-128

[10] Anderloni A, Fugazza A, Troncone E, et al. Single-step EUS-guided choledochoduodenostomy using a lumenapposing metal stent for malignant biliary obstruction. Gastrointestinal Endoscopy. 2019;**89**:69-76

[11] Mohan BP, Shakhatreh M, Garg R, et al. Efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy: A systematic review and meta-analysis. Journal of Clinical Gastroenterology. 2019;**53**:243-2250

[12] Park SJ, Choi JH, Park do H, et al. Expanding indication: EUS-guided hepaticoduodenostomy for isolated right intrahepatic bile duct obstruction (with video). Gastrointestinal Endoscopy. 2013;**78**:374-380

[13] Ogura T, Sno T, Onda S, et al. Endoscopic ultrasound-guided biliary drainage for right intrahepatic bile duct obstruction (with video). Endoscopy. 2015;**47**:72-75

[14] Khashab MA, Valeshabad AK, Kalloo AN, et al. A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Digestive Diseases and Sciences. 2015;**60**:557-565

[15] Ogura T, Masuda D, Takeuchi T, et al. Liver impaction technique to prevent sharing of the guidewire during endoscopic ultrasound-guided hepaticogastrostomy. Endoscopy. 2015;**47**:E583-E584

[16] Park do H, Jang JW, Lee SS, et al. EUS-guided biliary drainage with transluminal stenting after failed ERCP: Predictors of adverse events and long-term results. Gastrointestinal Endoscopy. 2011;**74**:1276-1284

[17] Ogura T, Nakai Y, Itoi T. Novel fine gauge electrocautery dilator for endoscopic ultrasound-guided hepaticogastrostomy (with video). Journal of Hepato-Biliary-Pancreatic Sciences. 2019;**26**:E3-E4

[18] Park do H, Jeong SU, Lee BU, et al. Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video). Gastrointestinal Endoscopy. 2013;**78**:91-101

[19] Ogura T, Kurisu Y, Masuda D, et al. Novel method of endoscopic ultrasound-guided hepaticogastrostomy to prevent stent dysfunction. Journal of Gastroenterology and Hepatology. 2014;**29**:1815-1821

[20] Paik WH, Park Do H, Choi JH, et al. Simplified fistula dilation technique and modified stent deployment maneuver for EUS-guided hepaticogastrostomy. World Journal of Gastroenterology. 2014;**20**:5051-5059

[21] Ogura T, Takagi W, Onda S, Masuda D, Takeuchi T, Fukunishi S, et al. Endoscopic ultrasound-guided biliary drainage with a novel fine-gauge balloon catheter: Simplified technique using a coaxial guidewire. Endoscopy. 2015;**47**:573-574

[22] Ogura T, Sano S, Onda S, Masuda D, Imoto A, Higuchi K. Endoscopic

ultrasound-guided biliary drainage with a novel fine-gauge balloon catheter: One-step placement technique. Endoscopy. 2015;**47**:245-246

[23] Park do H, Lee TH, Paik WH, et al. Feasibility and safety of a novel dedicated device for one-step EUSguided biliary drainage: A randomized trial. Journal of Gastroenterology and Hepatology. 2015;**30**:1461-1466

[24] Itoi T, Isayama H, Sofuni A, et al. Stent selection and tips on placement technique of EUS-guided biliary drainage: Transduodenal and transgastric stenting. Journal of Hepato-Biliary-Pancreatic Sciences. 2011;**18**:664-672

[25] Ogura T, Yamamoto K, Sano T, et al. Stent length is impact factor associated with stent patency in endoscopic ultrasound-guided hepaticogastrostomy. Journal of Gastroenterology and Hepatology. 2015;**30**:1748-1752

[26] Song TJ, Lee SS, Park do H, Seo DW, Lee SK, Kin MH. Preliminary report on a new hybrid metal stent for EUS-guided biliary drainage (with videos). Gastrointestinal Endoscopy. 2014;**80**:707-711

[27] Umeda J, Itoi T, Tsuchiya T, et al. A newly designed plastic stent for EUS-guided hepaticogastrostomy: A prospective preliminary feasibility study (with videos). Gastrointestinal Endoscopy. 2015;**82**:390-396.e2

[28] Miyano A, Ogura T, Yamamoto K, et al. Clinical impact of the intra-scope channel stent release technique in preventing stent migration during EUS-guided hepaticogastrostomy. Journal of Gastrointestinal Surgery. 2018;**22**:1312-1318

[29] Hedjoudje A, Sportes A, Grabar S, et al. Outcomes of endoscopic ultrasound-guided biliary drainage: A

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*EUS-Guided Biliary Drainage*

Journal. 2019;**7**:60-68

[30] Vila JJ, Perez-Miranda M, Vazquez-Sequerios E, et al. Initial experience with EUS-guided

[31] Teoh AYB, Sema C, Penas I, et al. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystectomy in patients who are unfit for cholecystectomy. Endoscopy.

2017;**49**:130-138

2016;**9**:19-25

*DOI: http://dx.doi.org/10.5772/intechopen.87970*

video). Gastrointestinal Endoscopy.

[37] Jang JW, Lee SS, Park DH, et al. Feasibility and safety of EUS-guided transgastric/transduodenal gallbladder drainage with single-step placement of a modified covered self-expandable metal stent in patients unsuitable for cholecystectomy. Gastrointestinal Endoscopy. 2011;**74**:176-181

[38] Jang JW, Lee SS, Song TJ, et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012;**142**:805-811

[39] Choi JH, Lee SS, Choi JH, et al. Long-term outcomes after endoscopic ultrasonography-guided gallbladder drainage for acute cholecystitis. Endoscopy. 2014;**46**:656-661

[40] Keida P, Sharaiha RZ, Kumta NA, et al. Endoscopic gallbladder drainage

drainage. Gastrointestinal Endoscopy.

[41] Kamata K, Takenaka M, Kitano M, et al. Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: Long-term outcomes after removal of a self-expandable metal stent. World Journal of Gastroenterology. 2017;**23**:661-667

[42] Kahaleh M, Perez-Miranda M, Artifon EL, et al. International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time? Digestive and Liver

[43] Khan MA, Atiq O, Kubilium N,

endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointestinal Endoscopy.

Disease. 2016;**48**:1054-1059

et al. Efficacy and safety of

2017;**85**:76-87

compared with percutaneous

2015;**82**:1031-1036

2010;**71**:634-640

systematic review and meta-analysis. United European Gastroenterology

cholangiopancreatography for biliary and pancreatic duct drainage: A Spanish national survey. Gastrointestinal Endoscopy. 2012;**76**:1133-1141

[32] Tyberg A, Saumoy M, Sequeiros EV, et al. EUS-guided versus percutaneous

gallbladder drainage: Isn't time to covert? Journal of Clinical Gastroenterology. 2018;**52**:79-84

[33] Takagi W, Ogura T, Sano T, et al. EUS-guided cholecystoduodenostomy for acute cholecystitis with an anti-stent migration and anti-food impaction system; a pilot study. Therapeutic Advances in Gastroenterology.

[34] Perez-Miranda M. Technical considerations in EUS-guided gallbladder drainage. Endoscopic

[35] Lee SS, Park DH, Hwang CY, et al. EUS-guided transluminal

cholecystectomy as rescue management for acute cholecystitis in elderly or highrisk patients: A prospective feasibility study. Gastrointestinal Endoscopy.

[36] Song TJ, Park DH, Eum JB, et al. EUS-guided cholecystoenterostomy with single-step placement of a 7Fr double-pigtail plastic stent in patients who are unsuitable for cholecystectomy: A pilot study (with

Ultrasound. 2018;**7**:79-82

2007;**66**:1008-1012

#### *EUS-Guided Biliary Drainage DOI: http://dx.doi.org/10.5772/intechopen.87970*

systematic review and meta-analysis. United European Gastroenterology Journal. 2019;**7**:60-68

*Advanced Endoscopy*

2015;**47**:E583-E584

[15] Ogura T, Masuda D, Takeuchi T, et al. Liver impaction technique to prevent sharing of the guidewire during endoscopic ultrasound-guided hepaticogastrostomy. Endoscopy.

ultrasound-guided biliary drainage with a novel fine-gauge balloon

[23] Park do H, Lee TH, Paik WH, et al. Feasibility and safety of a novel dedicated device for one-step EUSguided biliary drainage: A randomized trial. Journal of Gastroenterology and Hepatology. 2015;**30**:1461-1466

[24] Itoi T, Isayama H, Sofuni A, et al. Stent selection and tips on placement technique of EUS-guided biliary drainage: Transduodenal and transgastric stenting. Journal of Hepato-Biliary-Pancreatic Sciences.

[25] Ogura T, Yamamoto K, Sano T, et al. Stent length is impact factor associated with stent patency in endoscopic ultrasound-guided hepaticogastrostomy. Journal of Gastroenterology and Hepatology.

[26] Song TJ, Lee SS, Park do H, Seo DW, Lee SK, Kin MH. Preliminary report on a new hybrid metal stent for EUS-guided biliary drainage (with videos). Gastrointestinal Endoscopy.

[27] Umeda J, Itoi T, Tsuchiya T, et al. A newly designed plastic stent for EUS-guided hepaticogastrostomy: A prospective preliminary feasibility study (with videos). Gastrointestinal Endoscopy. 2015;**82**:390-396.e2

[28] Miyano A, Ogura T, Yamamoto K, et al. Clinical impact of the intra-scope channel stent release technique in preventing stent migration during EUS-guided hepaticogastrostomy. Journal of Gastrointestinal Surgery.

[29] Hedjoudje A, Sportes A, Grabar S,

ultrasound-guided biliary drainage: A

et al. Outcomes of endoscopic

2011;**18**:664-672

2015;**30**:1748-1752

2014;**80**:707-711

2018;**22**:1312-1318

Endoscopy. 2015;**47**:245-246

catheter: One-step placement technique.

[16] Park do H, Jang JW, Lee SS, et al. EUS-guided biliary drainage with transluminal stenting after failed ERCP: Predictors of adverse events and long-term results. Gastrointestinal

Endoscopy. 2011;**74**:1276-1284

Sciences. 2019;**26**:E3-E4

2013;**78**:91-101

2014;**29**:1815-1821

2014;**20**:5051-5059

2015;**47**:573-574

[21] Ogura T, Takagi W, Onda S, Masuda D, Takeuchi T, Fukunishi S, et al. Endoscopic ultrasound-guided biliary drainage with a novel fine-gauge balloon catheter: Simplified technique using a coaxial guidewire. Endoscopy.

[22] Ogura T, Sano S, Onda S, Masuda D, Imoto A, Higuchi K. Endoscopic

[17] Ogura T, Nakai Y, Itoi T. Novel fine gauge electrocautery dilator for endoscopic ultrasound-guided hepaticogastrostomy (with video). Journal of Hepato-Biliary-Pancreatic

[18] Park do H, Jeong SU, Lee BU, et al. Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video). Gastrointestinal Endoscopy.

[19] Ogura T, Kurisu Y, Masuda D, et al. Novel method of endoscopic ultrasound-guided hepaticogastrostomy to prevent stent dysfunction. Journal of Gastroenterology and Hepatology.

[20] Paik WH, Park Do H, Choi JH, et al. Simplified fistula dilation technique and modified stent deployment maneuver for EUS-guided hepaticogastrostomy. World Journal of Gastroenterology.

**72**

[30] Vila JJ, Perez-Miranda M, Vazquez-Sequerios E, et al. Initial experience with EUS-guided cholangiopancreatography for biliary and pancreatic duct drainage: A Spanish national survey. Gastrointestinal Endoscopy. 2012;**76**:1133-1141

[31] Teoh AYB, Sema C, Penas I, et al. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystectomy in patients who are unfit for cholecystectomy. Endoscopy. 2017;**49**:130-138

[32] Tyberg A, Saumoy M, Sequeiros EV, et al. EUS-guided versus percutaneous gallbladder drainage: Isn't time to covert? Journal of Clinical Gastroenterology. 2018;**52**:79-84

[33] Takagi W, Ogura T, Sano T, et al. EUS-guided cholecystoduodenostomy for acute cholecystitis with an anti-stent migration and anti-food impaction system; a pilot study. Therapeutic Advances in Gastroenterology. 2016;**9**:19-25

[34] Perez-Miranda M. Technical considerations in EUS-guided gallbladder drainage. Endoscopic Ultrasound. 2018;**7**:79-82

[35] Lee SS, Park DH, Hwang CY, et al. EUS-guided transluminal cholecystectomy as rescue management for acute cholecystitis in elderly or highrisk patients: A prospective feasibility study. Gastrointestinal Endoscopy. 2007;**66**:1008-1012

[36] Song TJ, Park DH, Eum JB, et al. EUS-guided cholecystoenterostomy with single-step placement of a 7Fr double-pigtail plastic stent in patients who are unsuitable for cholecystectomy: A pilot study (with video). Gastrointestinal Endoscopy. 2010;**71**:634-640

[37] Jang JW, Lee SS, Park DH, et al. Feasibility and safety of EUS-guided transgastric/transduodenal gallbladder drainage with single-step placement of a modified covered self-expandable metal stent in patients unsuitable for cholecystectomy. Gastrointestinal Endoscopy. 2011;**74**:176-181

[38] Jang JW, Lee SS, Song TJ, et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012;**142**:805-811

[39] Choi JH, Lee SS, Choi JH, et al. Long-term outcomes after endoscopic ultrasonography-guided gallbladder drainage for acute cholecystitis. Endoscopy. 2014;**46**:656-661

[40] Keida P, Sharaiha RZ, Kumta NA, et al. Endoscopic gallbladder drainage compared with percutaneous drainage. Gastrointestinal Endoscopy. 2015;**82**:1031-1036

[41] Kamata K, Takenaka M, Kitano M, et al. Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: Long-term outcomes after removal of a self-expandable metal stent. World Journal of Gastroenterology. 2017;**23**:661-667

[42] Kahaleh M, Perez-Miranda M, Artifon EL, et al. International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time? Digestive and Liver Disease. 2016;**48**:1054-1059

[43] Khan MA, Atiq O, Kubilium N, et al. Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointestinal Endoscopy. 2017;**85**:76-87

[44] Chen YI, Barkun AN, Adam V, et al. Cost-effectiveness analysis comparing lumen-apposing metal stents with plastic stents in the management of pancreatic walled-off necrosis. Gastrointestinal Endoscopy. 2018;**88**:267-276

Chapter 6

Abstract

1. Introduction

respectively).

75

Stents in Gastrointestinal Diseases

Stent is a medical device originally designed for recanalization and/or sealing of any obstructing or leaking lesion. In gastroenterology, it has a major role in recanalization of gastrointestinal (GI) tumors and postoperative leak sealing. Among several materials and models used in stent manufacturing, self-expandable metallic stents (SEMS) are the most common used stents. Over the years, SEMS has evolved into a standard of care medical device in several oncological conditions, such as advanced esophageal cancer. Other potential applications are drug-eluting devices, scar tissue modeling for benign conditions, and GI tract drainage/anastomosis. The aim of this chapter is to review the most common GI stent models and its

Stent is an artificial tube graft defined as "a short narrow metal or plastic tube often in the form of a mesh that is inserted into the lumen of an anatomical vessel (such as an artery or a bile duct) especially to keep a previously blocked passageway open" [1]. Stenting is a medical procedure for placing a stent. It should be differentiated from shunting, when a tube conduit is used for allowing flow between two previous unconnected structures. Splint refers to a rod- or a cast-like shell device placed outside any desired organ to make it stable. An endoprosthesis refers to a stent inserted into the lumen (endoluminal), which can be inside the gastrointestinal (GI) visceral tract (esophagus, stomach, duodenum, intestinal,

colorectal), or into a blood or biliary vessel (endovascular or endobiliary,

stent for the anastomosis" in experimental biliary surgery [2].

The term stent is an eponym of a British dentist, Charles T. Stent (1807–1885), who developed a compound originally used for dental impressions [2]. He developed a formula made of gutta-percha, a natural latex produced from tropical trees native to Southeast Asia and Northern Australia. The etymological origin of "stent" as a term in surgery started with Dr. Johannes F. Esser in 1917, which used Stent's dental compound as a mold for bridging skin grafts [2]. The term stent became popular among surgeons for such applications and was then later used to define any surgical mold for bridging tissues until a healing process has taken place, as in 1954, when a polyethylene tube was described by Drs. Remine and Grindlay as "to act as a

Eduardo Aimore Bonin, Bruno Verschoor,

and Susan Kakitani Takata

indications in gastrointestinal diseases.

Keywords: stent, gastroenterology, endoscopy

Fernanda Hoffmann Silva, Kelly Cristina Vieira

[45] Kunda R, Perez-Miranda M, Will U, et al. EUS-guided choledochoduodenostomy for malignant distal biliary obstruction using a lumenapposing fully covered metal stent after failed ERCP. Surgical Endoscopy. 2016;**30**:5002-5008

[46] Itoi T, Baron TH, Khashab MA, et al. Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017. Digestive Endoscopy. 2017;**29**:495-502

[47] Siddiqui AA, Kowalski TE, Loren DE, et al. Fully covered selfexpaandable metal stents versus lumen-apposing fully covered selfexpandable metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: Clinical outcomes and success. Gastrointestinal Endoscopy. 2017;**85**:758-765

[48] Ogura T, Higuchi K. Technical tips for endoscopic ultrasound-guided hepaticogastrostomy. World Journal of Gastroenterology. 2016;**22**:3945-3951

[49] Ogura T, Higuchi K. Technical tips of endoscopic ultrasoundguided choledochoduodenostomy. World Journal of Gastroenterology. 2015;**21**:820-828

[50] Ogura T, Higuchi K. Endoscopic ultrasound-guided gallbladder drainage: Current status and future prospects. Digestive Endoscopy. 2019;**31**(Suppl 1): 55-64

#### Chapter 6

*Advanced Endoscopy*

2018;**88**:267-276

2016;**30**:5002-5008

et al. Technical review of

Endoscopy. 2017;**29**:495-502

Endoscopy. 2017;**85**:758-765

[48] Ogura T, Higuchi K. Technical tips for endoscopic ultrasound-guided hepaticogastrostomy. World Journal of Gastroenterology. 2016;**22**:3945-3951

[49] Ogura T, Higuchi K. Technical tips of endoscopic ultrasoundguided choledochoduodenostomy. World Journal of Gastroenterology.

[50] Ogura T, Higuchi K. Endoscopic ultrasound-guided gallbladder drainage: Current status and future prospects. Digestive Endoscopy. 2019;**31**(Suppl 1):

2015;**21**:820-828

[47] Siddiqui AA, Kowalski TE, Loren DE, et al. Fully covered selfexpaandable metal stents versus lumen-apposing fully covered selfexpandable metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: Clinical outcomes and success. Gastrointestinal

[44] Chen YI, Barkun AN, Adam V, et al. Cost-effectiveness analysis comparing lumen-apposing metal stents with plastic stents in the management of pancreatic walled-off necrosis. Gastrointestinal Endoscopy.

[45] Kunda R, Perez-Miranda M, Will U, et al. EUS-guided

choledochoduodenostomy for malignant distal biliary obstruction using a lumenapposing fully covered metal stent after failed ERCP. Surgical Endoscopy.

[46] Itoi T, Baron TH, Khashab MA,

endoscopic ultrasonography-guided gastroenterostomy in 2017. Digestive

**74**

55-64

## Stents in Gastrointestinal Diseases

Eduardo Aimore Bonin, Bruno Verschoor, Fernanda Hoffmann Silva, Kelly Cristina Vieira and Susan Kakitani Takata

#### Abstract

Stent is a medical device originally designed for recanalization and/or sealing of any obstructing or leaking lesion. In gastroenterology, it has a major role in recanalization of gastrointestinal (GI) tumors and postoperative leak sealing. Among several materials and models used in stent manufacturing, self-expandable metallic stents (SEMS) are the most common used stents. Over the years, SEMS has evolved into a standard of care medical device in several oncological conditions, such as advanced esophageal cancer. Other potential applications are drug-eluting devices, scar tissue modeling for benign conditions, and GI tract drainage/anastomosis. The aim of this chapter is to review the most common GI stent models and its indications in gastrointestinal diseases.

Keywords: stent, gastroenterology, endoscopy

#### 1. Introduction

Stent is an artificial tube graft defined as "a short narrow metal or plastic tube often in the form of a mesh that is inserted into the lumen of an anatomical vessel (such as an artery or a bile duct) especially to keep a previously blocked passageway open" [1]. Stenting is a medical procedure for placing a stent. It should be differentiated from shunting, when a tube conduit is used for allowing flow between two previous unconnected structures. Splint refers to a rod- or a cast-like shell device placed outside any desired organ to make it stable. An endoprosthesis refers to a stent inserted into the lumen (endoluminal), which can be inside the gastrointestinal (GI) visceral tract (esophagus, stomach, duodenum, intestinal, colorectal), or into a blood or biliary vessel (endovascular or endobiliary, respectively).

The term stent is an eponym of a British dentist, Charles T. Stent (1807–1885), who developed a compound originally used for dental impressions [2]. He developed a formula made of gutta-percha, a natural latex produced from tropical trees native to Southeast Asia and Northern Australia. The etymological origin of "stent" as a term in surgery started with Dr. Johannes F. Esser in 1917, which used Stent's dental compound as a mold for bridging skin grafts [2]. The term stent became popular among surgeons for such applications and was then later used to define any surgical mold for bridging tissues until a healing process has taken place, as in 1954, when a polyethylene tube was described by Drs. Remine and Grindlay as "to act as a stent for the anastomosis" in experimental biliary surgery [2].

In gastroenterology, gastrointestinal stents have been originally used to treat obstructed cancer in the GI tract. From early modern medicine in the nineteenth century until nowadays, GI tract cancer or luminal palliation has always been a huge challenge for surgeons and physicians. In esophageal cancer, for example, nonsurgical attempts to relieve dysphagia and starvation from the early to mid-1800s were esophageal dilatation or placement of an esophageal gumlike, rubbermade tube. The esophageal tube was passed through the mouth or nose across the tumor, acting as a feeding tube, with no effect on dysphagia [3]. These early esophageal tubes ultimately gave place to flexible polyethylene or silicone nasogastric feeding tubes used today. It was a matter of time for physicians to come out with a solution involving an artificial tube that could fit across the tumor and relieve dysphagia. The first successful esophageal stenting procedure has been credited to Sir Charters James Symonds in 1885 [4], who developed an esophageal semirigid tube with a funnel attached to a silk suture to treat malignant esophageal tumors. This tube was orally and blindly inserted, and the suture was brought out from the mouth and attached to the patient's ear. Later in the 1920s– 1930s, a stent introducer over a guide-wire technique was developed to increase safety and facilitate stent insertion. After further technical developments with the aid of a flexible endoscope, several materials were used to increase softness. Gumlike or black rubber tubes gave place to tubes made of latex or silicone (the Celestin or Atkinson esophageal tube) or also polyvinyl, which all became popular in the 1960s–1980s [5]. Although being the best palliation measure at that time, avoiding surgery, these tubes were associated to high-risk complications, such as esophageal perforation. As they were semirigid, their passage through a narrow friable lumen required prior dilatation. To overcome this problem, a selfexpandable tube would be the solution. The first self-expandable metal stent (SEMS) models were stainless steel coil springs [5]. Their design was similar to endovascular stent models produced in the 1980s. For being developed for gastrointestinal (GI) tract use, they were inserted orally using an introducer and a fixation thread to tie them down into a compressed shape around an introducer or a gastroscope. Once positioned across the tumor, the stent was released to expand to its original shape using a novel feature that is producing significantly more radial force expansion instead of mostly axial. These stents became popular compared to their rigid plastic stent counterparts, especially after a first randomized study favoring SEMS over semirigid plastic stents for esophageal cancer [6]. Although being more expensive, they resulted in a higher cost-effectiveness due to their lower complication rates, lower hospitalization rate, and lower mortality. These stents gained significant improvement in design over time: a mesh-like stent to increase flexibility, while retaining a good radial expansion, a longer body, and a proximal flare at its end to prevent migration, and a synthetic covering film to prevent tumor ingrowth.

2. Stent types

Stents in Gastrointestinal Diseases

DOI: http://dx.doi.org/10.5772/intechopen.88117

(Figure 2) [7].

Figure 1.

Figure 2.

77

piercing into tissue. Picture from Eduardo A. Bonin.

foreshortening. Picture from Eduardo A. Bonin.

There are several different gastrointestinal stent shapes and materials (Figure 1), and there is no ideal stent type to date to fit all expectations.

Each distinguished shape and material have several physical properties, which enable a distinct function, ultimately influencing clinical outcome and stent choice

A laser-cut stent is a seamless metal tube (i.e., nitinol) being cut into several mesh stent patterns, which differs from a handmade woven, wire-braided or

A typical self-expandable metal stent. One is an uncovered colonic enteral stent (a) and another is a partially covered (silicone covering) esophageal stent (b). Its proximal flange has a larger caliber than its body, to ensure anchoring and prevent migration. Also, a curved wire flange instead of sharp struts is designed to prevent stent

Self-expandable stents, one totally made of plastic (silicone) (a), no longer commercially available for the gastrointestinal tract. The other is a multi-wire braided-type metal (nitinol), uncovered stent (b). Note the "kinking effect" of the plastic stent when compressed (a), where the metal stent remains patent, with some

The third-generation SEMS were made of nitinol (an acronym for nickel titanium Naval Ordnance Laboratories) [5], a so-called memory-shape alloy; once deformed it returns to its pre-deformed shape when heated. This results in a more flexible stent that can fit into a reduced caliber introducer/delivery system. Their first models had a higher foreshortening (25–40%) and a lower radial expansion compared to prior stainless steel models. As they gained later refinements in stent design and metal alloy, these stents are capable of being passed through a working channel of an endoscope to reach deeper parts of the gastrointestinal tract, reaching, for example, the proximal biliary tree, pancreatic duct, and proximal colon. Apart from other models made of self-expandable plastic or biodegradable material, nowadays SEMS remains the standard of care in most gastrointestinal stent applications.

### 2. Stent types

In gastroenterology, gastrointestinal stents have been originally used to treat obstructed cancer in the GI tract. From early modern medicine in the nineteenth century until nowadays, GI tract cancer or luminal palliation has always been a huge

challenge for surgeons and physicians. In esophageal cancer, for example, nonsurgical attempts to relieve dysphagia and starvation from the early to mid-1800s were esophageal dilatation or placement of an esophageal gumlike, rubbermade tube. The esophageal tube was passed through the mouth or nose across the tumor, acting as a feeding tube, with no effect on dysphagia [3]. These early esophageal tubes ultimately gave place to flexible polyethylene or silicone nasogastric feeding tubes used today. It was a matter of time for physicians to come out with a solution involving an artificial tube that could fit across the tumor and relieve dysphagia. The first successful esophageal stenting procedure has been credited to Sir Charters James Symonds in 1885 [4], who developed an esophageal

semirigid tube with a funnel attached to a silk suture to treat malignant

esophageal tumors. This tube was orally and blindly inserted, and the suture was brought out from the mouth and attached to the patient's ear. Later in the 1920s– 1930s, a stent introducer over a guide-wire technique was developed to increase safety and facilitate stent insertion. After further technical developments with the aid of a flexible endoscope, several materials were used to increase softness. Gumlike or black rubber tubes gave place to tubes made of latex or silicone (the Celestin or Atkinson esophageal tube) or also polyvinyl, which all became popular in the 1960s–1980s [5]. Although being the best palliation measure at that time, avoiding surgery, these tubes were associated to high-risk complications, such as esophageal perforation. As they were semirigid, their passage through a narrow friable lumen required prior dilatation. To overcome this problem, a selfexpandable tube would be the solution. The first self-expandable metal stent (SEMS) models were stainless steel coil springs [5]. Their design was similar to endovascular stent models produced in the 1980s. For being developed for gastrointestinal (GI) tract use, they were inserted orally using an introducer and a fixation

thread to tie them down into a compressed shape around an introducer or a gastroscope. Once positioned across the tumor, the stent was released to expand to its original shape using a novel feature that is producing significantly more radial force expansion instead of mostly axial. These stents became popular compared to their rigid plastic stent counterparts, especially after a first randomized study favoring SEMS over semirigid plastic stents for esophageal cancer [6]. Although being more expensive, they resulted in a higher cost-effectiveness due to their lower complication rates, lower hospitalization rate, and lower mortality. These stents gained significant improvement in design over time: a mesh-like stent to increase flexibility, while retaining a good radial expansion, a longer body, and a proximal flare at its end to prevent migration, and a synthetic covering film to prevent

The third-generation SEMS were made of nitinol (an acronym for nickel titanium Naval Ordnance Laboratories) [5], a so-called memory-shape alloy; once deformed it returns to its pre-deformed shape when heated. This results in a more flexible stent that can fit into a reduced caliber introducer/delivery system. Their first models had a higher foreshortening (25–40%) and a lower radial expansion compared to prior stainless steel models. As they gained later refinements in stent

working channel of an endoscope to reach deeper parts of the gastrointestinal tract, reaching, for example, the proximal biliary tree, pancreatic duct, and proximal colon. Apart from other models made of self-expandable plastic or biodegradable material, nowadays SEMS remains the standard of care in most gastrointestinal

design and metal alloy, these stents are capable of being passed through a

tumor ingrowth.

Advanced Endoscopy

stent applications.

76

There are several different gastrointestinal stent shapes and materials (Figure 1), and there is no ideal stent type to date to fit all expectations.

Each distinguished shape and material have several physical properties, which enable a distinct function, ultimately influencing clinical outcome and stent choice (Figure 2) [7].

A laser-cut stent is a seamless metal tube (i.e., nitinol) being cut into several mesh stent patterns, which differs from a handmade woven, wire-braided or

#### Figure 1.

A typical self-expandable metal stent. One is an uncovered colonic enteral stent (a) and another is a partially covered (silicone covering) esophageal stent (b). Its proximal flange has a larger caliber than its body, to ensure anchoring and prevent migration. Also, a curved wire flange instead of sharp struts is designed to prevent stent piercing into tissue. Picture from Eduardo A. Bonin.

#### Figure 2.

Self-expandable stents, one totally made of plastic (silicone) (a), no longer commercially available for the gastrointestinal tract. The other is a multi-wire braided-type metal (nitinol), uncovered stent (b). Note the "kinking effect" of the plastic stent when compressed (a), where the metal stent remains patent, with some foreshortening. Picture from Eduardo A. Bonin.

knitted stent configuration (Figure 2). A laser-cut stent has higher radial force and a lower foreshortening property, thus being more predictable when deployed. This can be useful in a straight narrow short lumen such as the biliary tree, a coronary vessel, or the bronchial tree [8]. They also have a higher radial force and higher longitudinal force. For some laser-cut stents with pointed struts at its distal end, longitudinal force might induce tissue reaction from direct piercing [8]. Wirebraided or knitted stents are more flexible and have a greater conformability (less "kinking effect") when deployed (Figure 2). They also allow placing another stent across its mesh, as required in some specific anatomic structures such as the biliary tree.

3. A typical SEMS placement procedure in the gastrointestinal tract

suture (older models).

Stents in Gastrointestinal Diseases

DOI: http://dx.doi.org/10.5772/intechopen.88117

4. Stent-related issues

Figure 3.

79

Eduardo A. Bonin.

stent choice, and lack of accessories/logistics [12].

A gastrointestinal stenting procedure usually requires the aid of an endoscope under radiological (fluoroscopy) guidance or at least one of these techniques. The procedure can be performed even in high-risk patients, with or without general anesthesia. Stent placement requires a special training and is reserved for interventional radiologists or interventional endoscopy gastroenterologists or surgeons. For SEMS placement there is an introducer system, in which the stent is compressed against a guiding catheter using an outer catheter sheath (Figure 3) or a thread

The procedure always requires a guide wire, with stiffness enough to avoid kinking, especially for passing a bulky fully covered large SEMS. For such stents a dilation procedure may be required using the smallest caliber dilation possible to avoid perforation. Fortunately, introducer systems are becoming thinner over time to facilitate insertion. Those are commonly used for intestinal and biliary stents. The stent and introducer system (Figure 3) is advanced over the guide wire and placed across the desired area. The stent is then deployed pulling back the outer catheter sheath (or advancing the outer catheter sheath, for a few models), under endoscopic or radiological guidance. The over-the-wire (OTW) technique refers to placing a stent over a guide wire having an endoscope alongside to ensure proper placement, with or without radiological guidance. The through-the-scope (TTS) technique refers to placing the stent over a guide wire using the working channel of an endoscope (Figure 3). Alternatively, one may compress the stent over an endoscope using sutures and release it at difficult-to-reach proximal portions of the gastrointestinal tract (over-the-scope technique) [11]. Technical issues can be related to a poor preclinical evaluation, lack of patient information consent, wrong

Nowadays, a huge effort in stent design is to overcome the most common stent-

A typical catheter-based self-expandable metal stent (SEMS) delivery system. The outer catheter has been pulled back to open the stent (white arrow). This can be done under radiological or endoscopic guidance. Note the SEMS being partially deployed (yellow arrow). The blue arrow depicts the proximal part of the delivery system, which is facing the distal flange of the SEMS (for duodenal and esophageal models). Note some foreshortening of the SEMS while being deployed (distance between the yellow and blue arrows). For biliary and colonic stents, the proximal flange is facing the proximal part of the catheter delivery system. Picture from

related issues: migration, stent-related perforation, and stent occlusion.

The most common stent types used in gastroenterology are made of semirigid, plastic tubes (polyethylene) or SEMS (nitinol or stainless steel mesh). Semirigid plastic tube stents are currently being used exclusively in the biliary tree and the pancreas [9]. They are commonly made of polyethylene, a softer plastic with a better molding capability compared to polyurethane. They remain a first-line and cost-effective method compared to fully covered SEMS in most biliopancreatic benign conditions (biliary stricture, fistula) with a lower migration rate, however having higher occlusion rates. Fully covered SEMS are currently being investigated for refractory benign biliary strictures (Table 5). Semirigid, plastic tubes are no longer used in the gastrointestinal tract (esophagus, stomach, or colorectal).

A typical SEMS design has a cylinder-shape body part, which is used to cover or seal the desired area, and a flare (funnel-like shape) at one or both extremities (Figure 1). Self-expandable plastic stents (SEPS) are another version of SEMS in terms of material used. SEMS can be found as uncovered or partially and totally covered using a synthetic covering film such as polyethylene or silicone (Figure 1).

Biodegradable stents and drug-eluting stents are other models under investigation. Biodegradable stents are made of biodegradable material (i.e., polyesters, polycarbonates, bacterial-derived polymers, and corrodible metals), mostly used in coronary artery disease. In gastroenterology, these stents are particularly useful in benign conditions, where a metallic stent would be incorporated to tissue over time, becoming very difficult to remove once achieving a stable luminal patency. Several models have been tested in clinical trials, and none has proved a consistent clinical result in terms of luminal patency. Drug-eluting stents are capable of maintaining patency not only from radial expansion but also from drug delivery directly to tissue, reducing its occlusion rates. These stents are very popular in cardiology, where they are superior to traditional bare stents to prevent coronary artery re-occlusion from endothelial intimal proliferation. In gastroenterology, they have been used in malignant disease to prevent tumor ingrowth and overgrowth. Despite the use of covered SEMS, its synthetic covering membrane is destroyed over time by hydrolysis and oxidation from gastrointestinal contents. Chemotherapeutic antitumoral agents, such as paclitaxel, have been initially tested with no proven benefit over the standard fully covered SEMS. For hydrophilic agents such as gemcitabine, a slow-release surface-stabilizing substance pullulan acetate has been added to increase optimal local drug release. Five-fluorouracil (5- FU) has also being tested as an antiproliferative agent for local tumor control in esophageal and biliopancreatic cancer [10]. Although promising, most of these stents are still in the experimental field, with scarce clinical experience. One major concern about these stents is local drug delivery causing injury to adjacent tissue and distant organ toxicity due to systemic exposure. Setting an appropriate drug concentration and release will enable an optimal local drug distribution to reach the desired effect.

knitted stent configuration (Figure 2). A laser-cut stent has higher radial force and a lower foreshortening property, thus being more predictable when deployed. This can be useful in a straight narrow short lumen such as the biliary tree, a coronary vessel, or the bronchial tree [8]. They also have a higher radial force and higher longitudinal force. For some laser-cut stents with pointed struts at its distal end, longitudinal force might induce tissue reaction from direct piercing [8]. Wirebraided or knitted stents are more flexible and have a greater conformability (less "kinking effect") when deployed (Figure 2). They also allow placing another stent across its mesh, as required in some specific anatomic structures such as the

The most common stent types used in gastroenterology are made of semirigid, plastic tubes (polyethylene) or SEMS (nitinol or stainless steel mesh). Semirigid plastic tube stents are currently being used exclusively in the biliary tree and the pancreas [9]. They are commonly made of polyethylene, a softer plastic with a better molding capability compared to polyurethane. They remain a first-line and cost-effective method compared to fully covered SEMS in most biliopancreatic benign conditions (biliary stricture, fistula) with a lower migration rate, however having higher occlusion rates. Fully covered SEMS are currently being investigated for refractory benign biliary strictures (Table 5). Semirigid, plastic tubes are no longer used in the gastrointestinal tract (esophagus, stomach,

A typical SEMS design has a cylinder-shape body part, which is used to cover or seal the desired area, and a flare (funnel-like shape) at one or both extremities (Figure 1). Self-expandable plastic stents (SEPS) are another version of SEMS in terms of material used. SEMS can be found as uncovered or partially and totally covered using a synthetic covering film such as polyethylene or silicone

Biodegradable stents and drug-eluting stents are other models under investigation. Biodegradable stents are made of biodegradable material (i.e., polyesters, polycarbonates, bacterial-derived polymers, and corrodible metals), mostly used in coronary artery disease. In gastroenterology, these stents are particularly useful in benign conditions, where a metallic stent would be incorporated to tissue over time, becoming very difficult to remove once achieving a stable luminal patency.

Several models have been tested in clinical trials, and none has proved a consistent clinical result in terms of luminal patency. Drug-eluting stents are capable of maintaining patency not only from radial expansion but also from drug delivery directly to tissue, reducing its occlusion rates. These stents are very popular in cardiology, where they are superior to traditional bare stents to prevent coronary artery re-occlusion from endothelial intimal proliferation. In gastroenterology, they have been used in malignant disease to prevent tumor ingrowth and overgrowth. Despite the use of covered SEMS, its synthetic covering membrane is destroyed over time by hydrolysis and oxidation from gastrointestinal contents. Chemotherapeutic antitumoral agents, such as paclitaxel, have been initially tested with no proven benefit over the standard fully covered SEMS. For hydrophilic agents such as gemcitabine, a slow-release surface-stabilizing substance pullulan acetate has been added to increase optimal local drug release. Five-fluorouracil (5- FU) has also being tested as an antiproliferative agent for local tumor control in esophageal and biliopancreatic cancer [10]. Although promising, most of these stents are still in the experimental field, with scarce clinical experience. One major concern about these stents is local drug delivery causing injury to adjacent tissue and distant organ toxicity due to systemic exposure. Setting an appropriate drug concentration and release will enable an optimal local drug distribution to reach

biliary tree.

Advanced Endoscopy

or colorectal).

(Figure 1).

the desired effect.

78

#### 3. A typical SEMS placement procedure in the gastrointestinal tract

A gastrointestinal stenting procedure usually requires the aid of an endoscope under radiological (fluoroscopy) guidance or at least one of these techniques. The procedure can be performed even in high-risk patients, with or without general anesthesia. Stent placement requires a special training and is reserved for interventional radiologists or interventional endoscopy gastroenterologists or surgeons. For SEMS placement there is an introducer system, in which the stent is compressed against a guiding catheter using an outer catheter sheath (Figure 3) or a thread suture (older models).

The procedure always requires a guide wire, with stiffness enough to avoid kinking, especially for passing a bulky fully covered large SEMS. For such stents a dilation procedure may be required using the smallest caliber dilation possible to avoid perforation. Fortunately, introducer systems are becoming thinner over time to facilitate insertion. Those are commonly used for intestinal and biliary stents. The stent and introducer system (Figure 3) is advanced over the guide wire and placed across the desired area. The stent is then deployed pulling back the outer catheter sheath (or advancing the outer catheter sheath, for a few models), under endoscopic or radiological guidance. The over-the-wire (OTW) technique refers to placing a stent over a guide wire having an endoscope alongside to ensure proper placement, with or without radiological guidance. The through-the-scope (TTS) technique refers to placing the stent over a guide wire using the working channel of an endoscope (Figure 3). Alternatively, one may compress the stent over an endoscope using sutures and release it at difficult-to-reach proximal portions of the gastrointestinal tract (over-the-scope technique) [11]. Technical issues can be related to a poor preclinical evaluation, lack of patient information consent, wrong stent choice, and lack of accessories/logistics [12].

#### Figure 3.

A typical catheter-based self-expandable metal stent (SEMS) delivery system. The outer catheter has been pulled back to open the stent (white arrow). This can be done under radiological or endoscopic guidance. Note the SEMS being partially deployed (yellow arrow). The blue arrow depicts the proximal part of the delivery system, which is facing the distal flange of the SEMS (for duodenal and esophageal models). Note some foreshortening of the SEMS while being deployed (distance between the yellow and blue arrows). For biliary and colonic stents, the proximal flange is facing the proximal part of the catheter delivery system. Picture from Eduardo A. Bonin.

#### 4. Stent-related issues

Nowadays, a huge effort in stent design is to overcome the most common stentrelated issues: migration, stent-related perforation, and stent occlusion.

Anchoring measures to prevent stent migration: the most popular anchoring measure is having a flange at its proximal end to anchor it against a more elastic, healthy GI tract wall proximal to the tumor. Using a barbed proximal end, similar as found in plastic tube stents, has the same principle. An uncovered stent (Figure 1) has a lower migration rate compared to a covered stent because it becomes fixed and embedded to tissue over time due to pressure necrosis. However, this poses a special problem for removing it, which is required in benign conditions. Partially covered stents (Figure 1) are stents covered only at the body of the stent, leaving its proximal end to embed into tissue. They are very popular for malignant esophageal and biliopancreatic cancer, but again, there is a problem in removing the stent when used in benign conditions. Other measures are stent fixation using an endoscopic clip (Figure 5) or using an endoscopic suturing device [13] or passing a temporary suture thread at its proximal end, coming out from a nostril and fixated at the ear (Figure 4). A double-layer stent (a fully covered stent with an outer uncovered mesh layer) has also been proposed (Figure 4). Lumen-apposing stents are fully covered SEMS with a larger flange that allows transluminal drainage procedures (Figure 8).

Stent-related perforation occurs due to gastrointestinal wall pressure necrosis due to stent compression, usually occurring at the stent's distal end. Perforation can be devastating and is more likely to occur when there is more angulation (surgically altered anatomy or the colon). More flexible and longer stents are less likely to have this issue, having in mind to avoid placing a short and/or more rigid or selfexpandable plastic stent at any sharp angulation.

Stent occlusion may occur from tumor ingrowth or overgrowth and/or accumulation of debris and bacterial biofilm deposit. Tumor overgrowth corresponds to

tumor growth at any of both ends of a stent. This is avoided by covering the tumor at least 2 cm away from any of both ends. Tumor ingrowth corresponds to tumor growing within the stent mesh. This has been largely supervened using a covering film (silicone, polyethylene, polyvinyl). Larger caliber stents and stents with a good radius force expansion are associated to a larger fluid flow, thus a lower risk of

A 65-year-old male with advanced mid-distal esophageal cancer treated with chemoradiation. He developed a liver metastasis and an extensive esophageal stenosis (a–c), refractory to dilatation. Because of dysphagia and an ongoing, non-curable disease, it was decided for esophageal stenting. Picture from Eduardo A. Bonin.

In clinical practice, stents are being used for gastrointestinal tract tumor palliation (luminal patency maintenance, luminal recanalization, tunneling), gastrointestinal bleeding (luminal vessel compression), gastrointestinal perforation or leak sealing (gastrointestinal fistula sealing), and gastrointestinal bypass or

For each stent application, there are several technical and clinical issues to be assessed. Technical success refers to a successful stent deployment across the GI tract for a specific function (tumor palliation, compression, or anastomosis). Generally speaking, a successfully deployed stent should remain in the desired position and ideally expanded to its full radial force until up to 48 hours after deployment. Clinical success refers to achieving a desired clinical endpoint (i.e., relief of dysphagia, biliary decompression, fistula sealing) from the first 3–30 days (early) or 3 months and beyond (later) after stent deployment. A bridging stent refers to a stent used as a temporary measure for GI tract decompression, as in obstructed colon cancer patients to avoid colostomy. Since stents are commonly used for palliation of end-of-life cancer patients, quality of life is also a major concern. Cost-effectiveness refers to evaluation of cost of the device and procedure, com-

plication, hospitalization, and mortality rates compared to other available

occlusion.

81

Figure 5.

Stents in Gastrointestinal Diseases

DOI: http://dx.doi.org/10.5772/intechopen.88117

5. Stents in gastrointestinal diseases

anastomosis (gastrointestinal transluminal drainage).

#### Figure 4.

Anchoring methods for stenting. A suture thread passed at the proximal flange can be used to anchor the stent at the level of the nostril (a, b, c, red arrows). Using a near-fully covered stent with a short uncovered line at the proximal flange allows ingrowth of granulating tissue to prevent migration (c, green arrows). A double-layer stent is a fully covered stent with an outer mesh layer to prevent migration (picture modified from www.stent.ne t.com).

#### Figure 5.

Anchoring measures to prevent stent migration: the most popular anchoring measure is having a flange at its proximal end to anchor it against a more elastic, healthy GI tract wall proximal to the tumor. Using a barbed proximal end, similar as found in plastic tube stents, has the same principle. An uncovered stent (Figure 1) has a lower migration rate compared to a covered stent because it becomes fixed and embedded to tissue over time due to pressure necrosis. However, this poses a special problem for removing it, which is required in benign conditions. Partially covered stents (Figure 1) are stents covered only at the body of the stent, leaving its proximal end to embed into tissue. They are very popular for malignant esophageal and biliopancreatic cancer, but again, there is a problem in removing the stent when used in benign conditions. Other measures are stent fixation using an endoscopic clip (Figure 5) or using an endoscopic suturing device [13] or passing a temporary suture thread at its proximal end, coming out from a nostril and fixated at the ear (Figure 4). A double-layer stent (a fully covered stent with an outer uncovered mesh layer) has also been proposed (Figure 4). Lumen-apposing stents are fully covered SEMS with a larger flange that allows transluminal drainage

Stent-related perforation occurs due to gastrointestinal wall pressure necrosis due to stent compression, usually occurring at the stent's distal end. Perforation can be devastating and is more likely to occur when there is more angulation (surgically altered anatomy or the colon). More flexible and longer stents are less likely to have

Stent occlusion may occur from tumor ingrowth or overgrowth and/or accumulation of debris and bacterial biofilm deposit. Tumor overgrowth corresponds to

Anchoring methods for stenting. A suture thread passed at the proximal flange can be used to anchor the stent at the level of the nostril (a, b, c, red arrows). Using a near-fully covered stent with a short uncovered line at the proximal flange allows ingrowth of granulating tissue to prevent migration (c, green arrows). A double-layer stent is a fully covered stent with an outer mesh layer to prevent migration (picture modified from www.stent.ne

this issue, having in mind to avoid placing a short and/or more rigid or self-

expandable plastic stent at any sharp angulation.

procedures (Figure 8).

Advanced Endoscopy

Figure 4.

t.com).

80

A 65-year-old male with advanced mid-distal esophageal cancer treated with chemoradiation. He developed a liver metastasis and an extensive esophageal stenosis (a–c), refractory to dilatation. Because of dysphagia and an ongoing, non-curable disease, it was decided for esophageal stenting. Picture from Eduardo A. Bonin.

tumor growth at any of both ends of a stent. This is avoided by covering the tumor at least 2 cm away from any of both ends. Tumor ingrowth corresponds to tumor growing within the stent mesh. This has been largely supervened using a covering film (silicone, polyethylene, polyvinyl). Larger caliber stents and stents with a good radius force expansion are associated to a larger fluid flow, thus a lower risk of occlusion.

#### 5. Stents in gastrointestinal diseases

In clinical practice, stents are being used for gastrointestinal tract tumor palliation (luminal patency maintenance, luminal recanalization, tunneling), gastrointestinal bleeding (luminal vessel compression), gastrointestinal perforation or leak sealing (gastrointestinal fistula sealing), and gastrointestinal bypass or anastomosis (gastrointestinal transluminal drainage).

For each stent application, there are several technical and clinical issues to be assessed. Technical success refers to a successful stent deployment across the GI tract for a specific function (tumor palliation, compression, or anastomosis). Generally speaking, a successfully deployed stent should remain in the desired position and ideally expanded to its full radial force until up to 48 hours after deployment. Clinical success refers to achieving a desired clinical endpoint (i.e., relief of dysphagia, biliary decompression, fistula sealing) from the first 3–30 days (early) or 3 months and beyond (later) after stent deployment. A bridging stent refers to a stent used as a temporary measure for GI tract decompression, as in obstructed colon cancer patients to avoid colostomy. Since stents are commonly used for palliation of end-of-life cancer patients, quality of life is also a major concern. Cost-effectiveness refers to evaluation of cost of the device and procedure, complication, hospitalization, and mortality rates compared to other available


#### Table 1.

Level of evidence and strength of recommendation (extracted from [14]).

techniques in terms of clinical success and quality of life. SEMS are often more costeffective than traditional or laparoscopic surgery for palliation of cancer in high-risk patients.

GI stenting is one of many nonsurgical methods to achieve palliation of gastrointestinal cancer. Stents are more popular compared to other technologies for upper GI luminal recanalization/tunneling-ablation such as Nd:YAG laser ablation, argon plasma coagulation, or brachytherapy because it is the first-line recommended method [14] and it is an affordable single device with high technical success rates (approaching 90%) and no need for specific or expensive, dedicated equipment. For its widespread use, it is the most common nonsurgical palliation technique used for GI tract cancer worldwide. There are several recommendation guidelines for GI stenting from Western and Eastern surgical and gastrointestinal endoscopy societies based on evidence medicine (Table 1) [14]. For this present chapter, we have selected the most recently published guidelines.

#### 6. Indications

#### 6.1 Gastrointestinal cancer

Stenting is a first-line approach to esophageal cancer palliation [15] (Table 2, Figures 5 and 6).

Initial historical attempts to relieve dysphagia and alleviate starvation were esophageal dilatation and the use of an esophageal catheter-like tube. This first measure is temporary, unsuccessful over time due to tumor growth and associated to high risk of perforation. It can be still used as an initial approach in areas with no access to more advanced resources. The main, absolute indication for esophageal stenting is tracheoesophageal cancer fistula. Esophageal dysphagia is another major indication; however, it has been balanced with esophageal brachytherapy, when available. Esophageal stenting leads to a better quality of life mainly because of

relief of dysphagia. It also helps in patient's nutritional condition, but this should not be highly expected. The clinical success rates for dysphagia are 80–95%, with a median duration of esophageal stent patency being reported as 94% at 4 weeks, 78% at 3 months, and 67% at 6 months [16]. Recurrent obstruction occurs in 30% of patients, and migration rate is more common for covered stents (10–25%) than uncovered stents (2–5%). Stent placement can be considered as a temporary/bridge measure for those who have severe dysphagia before radio- or chemotherapy (neoadjuvant therapy). However, the stent has to be removed after a few weeks,

The same patient as in Figure 5. A 23 mm/12 cm partially covered self-expandable metal stent was placed covering the stenosis. The stent migrated distally 2 days after the procedure, which required repositioning. The stent was then fixed with clips at its proximal end (a, b, blue arrows). The patient resumed oral diet, and the stent remained in place, with its distal end at the level of the cardia (b, c, green arrows). Picture from Eduardo

1. Placement of partially or fully covered self-expandable metal stents (SEMS) is recommended for palliative treatment of malignant dysphagia over laser therapy, photodynamic therapy, and

2. For patients with longer life expectancy, brachytherapy is recommended as a valid alternative or in addition to stenting in esophageal cancer patients with malignant dysphagia. Brachytherapy may provide a survival advantage and possibly a better quality of life compared to SEMS placement alone

tracheoesophageal or bronchoesophageal fistula (strong recommendation, low-quality evidence) 4. The use of concurrent external radiotherapy and esophageal stent treatment is not recommended. SEMS placement is also not recommended as a bridge to surgery or prior to preoperative chemoradiotherapy. It is associated with a high incidence of adverse events, and alternative satisfactory options such as placement of a feeding tube are available (strong recommendation, low-

esophageal bypass (strong recommendation, high-quality evidence)

Recommendations for stenting in esophageal cancer (modified from [15]).

3. SEMS placement is recommended as the preferred treatment for sealing malignant

(strong recommendation, high-quality evidence)

quality evidence)

Stents in Gastrointestinal Diseases

DOI: http://dx.doi.org/10.5772/intechopen.88117

Table 2.

Figure 6.

A. Bonin.

83


#### Table 2.

techniques in terms of clinical success and quality of life. SEMS are often more costeffective than traditional or laparoscopic surgery for palliation of cancer in high-risk

Further research is unlikely to change our confidence in the estimate of effect. Consistent evidence from RCTs without important limitations or exceptionally

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Evidence from RCTs with important limitations (inconsistent results, methodological flaws, indirect, or

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Evidence for at least one critical outcome from observational studies, case series, or RCTs with

The best action may differ depending on the circumstances or patient or society

imprecise) or very strong evidence from observational studies

Recommendation can apply to most patients in most circumstances.

serious flaws, indirect evidence, or expert consensus

values. Other alternatives may be equally reasonable

strong evidence from observational studies

GI stenting is one of many nonsurgical methods to achieve palliation of gastrointestinal cancer. Stents are more popular compared to other technologies for upper GI luminal recanalization/tunneling-ablation such as Nd:YAG laser ablation, argon plasma coagulation, or brachytherapy because it is the first-line recommended method [14] and it is an affordable single device with high technical success rates (approaching 90%) and no need for specific or expensive, dedicated equipment. For its widespread use, it is the most common nonsurgical palliation technique used for GI tract cancer worldwide. There are several recommendation guidelines for GI stenting from Western and Eastern surgical and gastrointestinal endoscopy societies based on evidence medicine (Table 1) [14]. For this present chapter, we have

Stenting is a first-line approach to esophageal cancer palliation [15] (Table 2,

Initial historical attempts to relieve dysphagia and alleviate starvation were esophageal dilatation and the use of an esophageal catheter-like tube. This first measure is temporary, unsuccessful over time due to tumor growth and associated to high risk of perforation. It can be still used as an initial approach in areas with no access to more advanced resources. The main, absolute indication for esophageal stenting is tracheoesophageal cancer fistula. Esophageal dysphagia is another major indication; however, it has been balanced with esophageal brachytherapy, when available. Esophageal stenting leads to a better quality of life mainly because of

selected the most recently published guidelines.

Level of evidence and strength of recommendation (extracted from [14]).

patients.

Table 1.

Level of evidence A. High-quality evidence

Advanced Endoscopy

B. Moderate-quality

evidence

1. Strong recommendation

2. Weak recommendation

C. Low-quality evidence

Strength of recommendation

RCT, randomized controlled trial.

6. Indications

Figures 5 and 6).

82

6.1 Gastrointestinal cancer

Recommendations for stenting in esophageal cancer (modified from [15]).

#### Figure 6.

The same patient as in Figure 5. A 23 mm/12 cm partially covered self-expandable metal stent was placed covering the stenosis. The stent migrated distally 2 days after the procedure, which required repositioning. The stent was then fixed with clips at its proximal end (a, b, blue arrows). The patient resumed oral diet, and the stent remained in place, with its distal end at the level of the cardia (b, c, green arrows). Picture from Eduardo A. Bonin.

relief of dysphagia. It also helps in patient's nutritional condition, but this should not be highly expected. The clinical success rates for dysphagia are 80–95%, with a median duration of esophageal stent patency being reported as 94% at 4 weeks, 78% at 3 months, and 67% at 6 months [16]. Recurrent obstruction occurs in 30% of patients, and migration rate is more common for covered stents (10–25%) than uncovered stents (2–5%). Stent placement can be considered as a temporary/bridge measure for those who have severe dysphagia before radio- or chemotherapy (neoadjuvant therapy). However, the stent has to be removed after a few weeks,

#### Advanced Endoscopy

and a high migration risk is expected once the tumor responds and reduces its size from treatment. Thus, the cost-benefit of a bridging stent for esophageal cancer remains controversial. Several anti-reflux in-stent valve mechanisms have been used for preventing gastroesophageal reflux in distal esophageal tumors; however, it seems not to add any advantage over standard esophageal SEMS [17].

Gastroduodenal outlet obstruction (GOO) may rise from a locally advanced gastric, duodenal, or pancreatic cancer. It occurs in up to 20% of pancreatic cancer patients and is associated to recurrent vomiting, severe weight loss, and malnutrition. This condition is associated to a poor prognosis, with a 3–4 month average life expectancy. Stent placement should be considered for palliation of such patients, especially those who are not fit for surgery or have metastatic cancer (Figure 7). Patients with pancreatic cancer and a larger life expectancy have always the option for a surgical bypass, which nowadays is achieved using minimally invasive laparoscopic techniques. Surgical bypass appears to offer a longer luminal patency compared to stents for patients with GOO with a life expectation of more than 2 months [19]. Patients with locally advanced gastric cancer who are fit for surgery can be considered for gastric resection (partial gastrectomy) as a palliation method [20], since it treats the obstruction and also reduces the chance of tumor bleeding. Although peritoneal disease (carcinomatosis) is considered a relative contraindication to SEMS placement for GOO given the risk of multifocal obstruction, this procedure seems reasonable in such advanced gastric cancer

For malignant biliopancreatic diseases, SEMS are preferred over traditional plastic tube stents due to its better cost-effectiveness (lower occlusion rates) [22]. This applies to biliary obstruction in pancreatic cancer and biliary tract cancer. Apart from some evidence-based recommendations [23] (Table 3), there are several other clinical aspects in biliary and pancreatic stenting that are beyond the

In colorectal cancer, acute colonic obstruction represents a major complication, since it requires prompt intervention because of the risk of colonic necrosis and perforation. It is the primary symptom for 10–30% of patients with colorectal cancer. Others may develop colonic obstruction under their course of any nonsurgical adjuvant therapy. Emergency surgery for an acute obstructed colonic cancer is associated with a morbidity rate of 32–64% and mortality rate

1. Routine preoperative biliary drainage is not recommended in patients with malignant extrahepatic biliary obstruction; preoperative biliary drainage should be reserved for patients with cholangitis, severe symptomatic jaundice (e.g., intense pruritus), or delayed surgery or before neoadjuvant chemotherapy in jaundiced patients (strong recommendation, moderate-quality evidence) 2. Endoscopic placement of a 10 mm diameter self-expandable metal stent (SEMS) is recommended for preoperative biliary drainage of malignant extrahepatic biliary obstruction (strong recommendation,

3. SEMS insertion is recommended for palliative drainage of extrahepatic malignant biliary obstruction

4. Insertion of uncovered SEMS is not recommended for the drainage of extrahepatic biliary obstruction of unconfirmed etiology (strong recommendation, low-quality evidence) 5. Routine preoperative biliary drainage is not recommended in patients with malignant hilar

6. Uncovered SEMS is recommended for palliative drainage of malignant hilar obstruction (strong

7. Temporary insertion of multiple plastic stents or of a fully covered SEMS is recommended for treatment of benign biliary strictures (strong recommendation, moderate-quality evidence) 8. Endoscopic placement of plastic stent(s) is recommended to treat bile duct leaks that are not due to transection of the common bile duct or common hepatic duct (strong recommendation, moderate-

patients [21].

of 15–34% [24].

scope of this book chapter.

Stents in Gastrointestinal Diseases

DOI: http://dx.doi.org/10.5772/intechopen.88117

moderate-quality evidence)

quality evidence)

Table 3.

85

(strong recommendation, high-quality evidence)

recommendation, moderate-quality evidence)

obstruction (weak recommendation, low-quality evidence)

Recommendations for stenting in biliopancreatic diseases (modified from [23]).

Chemotherapy and radiotherapy have evolved over the years into better quality of life scores in palliation of esophageal cancer patients, since many of them are spared from dysphagia for several months on the course of disease. The correct timing for esophageal stent insertion is crucial for a better clinical outcome. It is usually considered when there is an ongoing disease and dysphagia despite optimal previous chemotherapy and radiotherapy treatment. Esophageal stenting with SEMS is superior to any other surgical palliation method for any given patient. It is also superior to gastrostomy for nutritional therapy in advanced cancer patients. Combinations of brachytherapy with SEMS are an interesting approach due to a reduced requirement for re-interventions [18].

#### Figure 7.

A 90-year-old male with gastric outlet obstruction due to advanced gastric (antral) cancer. He was not clinically fit for a surgical intervention. A duodenal stent was inserted endoscopically. He was able to eat per mouth until he deceased 6 months later because of advanced cancer and pneumonia. The red arrow depicts the proximal flange, located at the antrum (a, b). The distal flange is at the duodenum (c, d, yellow arrow). Picture from Eduardo A. Bonin.

and a high migration risk is expected once the tumor responds and reduces its size from treatment. Thus, the cost-benefit of a bridging stent for esophageal cancer remains controversial. Several anti-reflux in-stent valve mechanisms have been used for preventing gastroesophageal reflux in distal esophageal tumors; however,

Chemotherapy and radiotherapy have evolved over the years into better quality of life scores in palliation of esophageal cancer patients, since many of them are spared from dysphagia for several months on the course of disease. The correct timing for esophageal stent insertion is crucial for a better clinical outcome. It is usually considered when there is an ongoing disease and dysphagia despite optimal previous chemotherapy and radiotherapy treatment. Esophageal stenting with SEMS is superior to any other surgical palliation method for any given patient. It is also superior to gastrostomy for nutritional therapy in advanced cancer patients. Combinations of brachytherapy with SEMS are an interesting approach due to a

it seems not to add any advantage over standard esophageal SEMS [17].

A 90-year-old male with gastric outlet obstruction due to advanced gastric (antral) cancer. He was not clinically fit for a surgical intervention. A duodenal stent was inserted endoscopically. He was able to eat per mouth until he deceased 6 months later because of advanced cancer and pneumonia. The red arrow depicts the proximal flange, located at the antrum (a, b). The distal flange is at the duodenum (c, d, yellow arrow).

reduced requirement for re-interventions [18].

Advanced Endoscopy

Figure 7.

84

Picture from Eduardo A. Bonin.

Gastroduodenal outlet obstruction (GOO) may rise from a locally advanced gastric, duodenal, or pancreatic cancer. It occurs in up to 20% of pancreatic cancer patients and is associated to recurrent vomiting, severe weight loss, and malnutrition. This condition is associated to a poor prognosis, with a 3–4 month average life expectancy. Stent placement should be considered for palliation of such patients, especially those who are not fit for surgery or have metastatic cancer (Figure 7).

Patients with pancreatic cancer and a larger life expectancy have always the option for a surgical bypass, which nowadays is achieved using minimally invasive laparoscopic techniques. Surgical bypass appears to offer a longer luminal patency compared to stents for patients with GOO with a life expectation of more than 2 months [19]. Patients with locally advanced gastric cancer who are fit for surgery can be considered for gastric resection (partial gastrectomy) as a palliation method [20], since it treats the obstruction and also reduces the chance of tumor bleeding. Although peritoneal disease (carcinomatosis) is considered a relative contraindication to SEMS placement for GOO given the risk of multifocal obstruction, this procedure seems reasonable in such advanced gastric cancer patients [21].

For malignant biliopancreatic diseases, SEMS are preferred over traditional plastic tube stents due to its better cost-effectiveness (lower occlusion rates) [22]. This applies to biliary obstruction in pancreatic cancer and biliary tract cancer. Apart from some evidence-based recommendations [23] (Table 3), there are several other clinical aspects in biliary and pancreatic stenting that are beyond the scope of this book chapter.

In colorectal cancer, acute colonic obstruction represents a major complication, since it requires prompt intervention because of the risk of colonic necrosis and perforation. It is the primary symptom for 10–30% of patients with colorectal cancer. Others may develop colonic obstruction under their course of any nonsurgical adjuvant therapy. Emergency surgery for an acute obstructed colonic cancer is associated with a morbidity rate of 32–64% and mortality rate of 15–34% [24].


#### Table 3.

Recommendations for stenting in biliopancreatic diseases (modified from [23]).


#### Table 4.

Recommendations for stenting in colorectal cancer (modified from [26]).

Stenting of obstructed colon cancer is mainly used for palliation in advanced left-sided high-risk colonic cancer patients (Table 4) [25, 26], since it avoids a definitive stoma, with a potential increase in quality of life. It can also be used as an alternative temporary decompression measure as a bridge before surgical resection, as it may prevent the need of a stoma (colostomy) in 30–40% of cases. However, there are some concerns regarding its safety and long-term oncological issues [27]. Colonic stenting is associated to technical and clinical success rate approaching 90%. It has an overall adverse event rate of up to 25% (perforation, migration, colonic decompression failure as major events, pain as minor event). Patients at higher risk of major events have strictures longer than 4 cm and complete obstruction. A colonic decompression failure may require urgent surgery. Perforation is another feared complication, with an estimated rate of 9.5%. Stent migration usually occurs within a week after placement at a rate of 10% of patients when used as a bridge to surgery, whereas stent occlusion occurs in 10% of palliative patients [27], usually 3–6 months after placement (tumor growth). Covered stents are solely used in benign conditions, with a migration rate reaching up to 90% within 1–3 weeks after placement [25].

following an intense inflammatory process [30]. Gastrointestinal leakage may also occur postoperatively after a given gastrointestinal anastomosis. Any of these situations may lead to gastrointestinal fluid leak/extravasation and consequent abdominal cavity contamination, leading to an established communication (fistula) of the afflicted organ to the abdominal cavity or to other GI tract compartments or the skin. Gastrointestinal stenting may aid as a sealing procedure to avoid gastrointestinal content leakage and also to maintain luminal patency, reducing any pressure

1. SEMS is not recommended as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and costs (strong

2. Temporary placement of SEMS should be considered as therapy for refractory benign esophageal strictures (weak recommendation, moderate-quality evidence). Stents should usually be removed at

3. Fully covered SEMS are preferred over partially covered SEMS for the treatment of refractory benign esophageal strictures, because of their lack of embedment and ease of removability (weak

perforations. The optimal stenting duration remains unclear and should be individualized (strong

6. Placement of a SEMS is recommended for the treatment of esophageal variceal bleeding refractory to medical, endoscopic, and/or radiological therapy or as initial therapy for patients with massive

4. For the removal of partially covered esophageal SEMS that are embedded, the stent-in-stent

5. Temporary stent placement can be considered for treating esophageal leaks, fistulas, and

esophageal variceal bleeding (strong recommendation, moderate-quality evidence)

a maximum of 3 months (strong recommendation, low-quality evidence)

technique is recommended (strong recommendation, low-quality evidence)

recommendation, low-quality evidence)

DOI: http://dx.doi.org/10.5772/intechopen.88117

Stents in Gastrointestinal Diseases

recommendation, low-quality evidence)

recommendation, low-quality evidence)

Recommendations for stenting for benign disease (modified from [15]).

Gastroesophageal varices are mostly found in cirrhotic patients. Other causes include Schistosoma infection and portal vein thrombosis from other causes excluding cirrhosis. They may lead to massive bleeding with a high-rate mortality. Variceal band ligation and endoscopic injection therapy are the treatment of choice for ongoing acute variceal bleeding despite medical management. However, patients with massive refractory bleeding and coagulation impairment (usually due to cirrhosis) may require a life-saving tamponade measure, usually done using an esophagogastric balloon device (Sengstaken-Blakemore tube). This device requires a highly compromised team to take care of the balloon device tube and is very uncomfortable for an awaken patient. It also leads to complications such as mucosal

from an unexpected gastrointestinal anastomotic stricture (Table 5).

ischemic injury. Stenting has emerged as an alternative effective temporary tamponade measure for such bleeding cases until a definitive treatment can be

Transgastric pancreatic fluid collection drainage (cystogastrostomy drainage) has been for at least 20 years the most popular representative of a typical transmural endoscopic drainage procedure (Figure 8). Until 5 years ago, no one would assume a gastrointestinal anastomosis being performed totally under endoscopic technique in the clinical setting, until a novel lumen-apposing self-expandable metal stent

applied (Table 5).

Table 5.

8. Other indications

(LAMS) has been developed.

87

8.1 Gastrointestinal bypass/drainage/anastomosis

#### 7. Benign gastrointestinal tract conditions

#### 7.1 Gastrointestinal strictures, fistulas, and bleeding tamponade

Benign GI tract strictures usually occur from previous surgery (anastomotic) or post-radiotherapy. Caustic chemically induced esophageal strictures are fortunately becoming more rare due to chemical commercial restrictions. Recalcitrant gastrointestinal strictures remain a huge clinical challenge, since results are not consistent and no single therapy has been proven uniformly efficacious. Gastrointestinal stenting has emerged as an alternative therapy for benign stricture treatment, and a fully covered SEMS has been regarded the stent of choice, preferably using a fixation method (Table 5) [28].

Gastrointestinal perforation and fistula management have evolved dramatically over the last 15 years toward a noninvasive endoscopic treatment. Gastrointestinal perforation or laceration usually refers to any gastrointestinal full-thickness wall opening that can occur during a therapeutic endoscopic procedure [29] or spontaneously from intense vomiting (Boerhaave syndrome) or gut wall necrosis


#### Table 5.

Stenting of obstructed colon cancer is mainly used for palliation in advanced left-sided high-risk colonic cancer patients (Table 4) [25, 26], since it avoids a definitive stoma, with a potential increase in quality of life. It can also be used as an alternative temporary decompression measure as a bridge before surgical resection, as it may prevent the need of a stoma (colostomy) in 30–40% of cases. However, there are some concerns regarding its safety and long-term oncological issues [27]. Colonic stenting is associated to technical and clinical success rate approaching 90%. It has an overall adverse event rate of up to 25% (perforation, migration, colonic decompression failure as major events, pain as minor event). Patients at higher risk of major events have strictures longer than 4 cm and complete obstruction. A colonic decompression failure may require urgent surgery. Perforation is another feared complication, with an estimated rate of 9.5%. Stent migration usually occurs within a week after placement at a rate of 10% of patients when used as a bridge to surgery, whereas stent occlusion occurs in 10% of palliative patients [27], usually 3–6 months after placement (tumor growth). Covered stents are solely used in benign conditions, with a migration rate reaching up to 90% within 1–3 weeks

1. Prophylactic colonic stent placement is not recommended. Colonic stenting should be reserved for patients with clinical symptoms and imaging evidence of malignant large-bowel obstruction, without

2. Colonic SEMS placement as a bridge to elective surgery is not recommended as a standard treatment of symptomatic left-sided malignant colonic obstruction (strong recommendation, high-quality

3. For patients with potentially curable but obstructing left-sided colonic cancer, stent placement may be considered as an alternative to emergency surgery in those who have an increased risk of postoperative mortality, i.e., American Society of Anesthesiologists (ASA) physical status ≥ III and/

4. SEMS placement is recommended as the preferred treatment for palliation of malignant colonic obstruction (strong recommendation, high-quality evidence), except in patients treated or considered for treatment with antiangiogenic drugs (e.g., bevacizumab) (strong recommendation,

signs of perforation (strong recommendation, low-quality evidence)

or age > 70 years (weak recommendation, low-quality evidence)

Recommendations for stenting in colorectal cancer (modified from [26]).

after placement [25].

evidence)

Advanced Endoscopy

Table 4.

low-quality evidence)

fixation method (Table 5) [28].

86

7. Benign gastrointestinal tract conditions

7.1 Gastrointestinal strictures, fistulas, and bleeding tamponade

Benign GI tract strictures usually occur from previous surgery (anastomotic) or post-radiotherapy. Caustic chemically induced esophageal strictures are fortunately becoming more rare due to chemical commercial restrictions. Recalcitrant gastrointestinal strictures remain a huge clinical challenge, since results are not consistent and no single therapy has been proven uniformly efficacious. Gastrointestinal stenting has emerged as an alternative therapy for benign stricture treatment, and a fully covered SEMS has been regarded the stent of choice, preferably using a

Gastrointestinal perforation and fistula management have evolved dramatically over the last 15 years toward a noninvasive endoscopic treatment. Gastrointestinal perforation or laceration usually refers to any gastrointestinal full-thickness wall opening that can occur during a therapeutic endoscopic procedure [29] or sponta-

neously from intense vomiting (Boerhaave syndrome) or gut wall necrosis

Recommendations for stenting for benign disease (modified from [15]).

following an intense inflammatory process [30]. Gastrointestinal leakage may also occur postoperatively after a given gastrointestinal anastomosis. Any of these situations may lead to gastrointestinal fluid leak/extravasation and consequent abdominal cavity contamination, leading to an established communication (fistula) of the afflicted organ to the abdominal cavity or to other GI tract compartments or the skin. Gastrointestinal stenting may aid as a sealing procedure to avoid gastrointestinal content leakage and also to maintain luminal patency, reducing any pressure from an unexpected gastrointestinal anastomotic stricture (Table 5).

Gastroesophageal varices are mostly found in cirrhotic patients. Other causes include Schistosoma infection and portal vein thrombosis from other causes excluding cirrhosis. They may lead to massive bleeding with a high-rate mortality. Variceal band ligation and endoscopic injection therapy are the treatment of choice for ongoing acute variceal bleeding despite medical management. However, patients with massive refractory bleeding and coagulation impairment (usually due to cirrhosis) may require a life-saving tamponade measure, usually done using an esophagogastric balloon device (Sengstaken-Blakemore tube). This device requires a highly compromised team to take care of the balloon device tube and is very uncomfortable for an awaken patient. It also leads to complications such as mucosal ischemic injury. Stenting has emerged as an alternative effective temporary tamponade measure for such bleeding cases until a definitive treatment can be applied (Table 5).

#### 8. Other indications

#### 8.1 Gastrointestinal bypass/drainage/anastomosis

Transgastric pancreatic fluid collection drainage (cystogastrostomy drainage) has been for at least 20 years the most popular representative of a typical transmural endoscopic drainage procedure (Figure 8). Until 5 years ago, no one would assume a gastrointestinal anastomosis being performed totally under endoscopic technique in the clinical setting, until a novel lumen-apposing self-expandable metal stent (LAMS) has been developed.

#### Figure 8.

Lumen-apposing self-expandable metal stent used for transgastric drainage of a walled of pancreatic necrosis. (a) Four weeks after transgastric endoscopic necrosectomy, the resulting cavity has been replaced by granulating tissue. The stent was then removed. The stent has large flanges to avoid migration (b) and a 14 mm lumen to allow endoscope insertion (c). Picture from Eduardo A. Bonin.

This totally covered, dumbbell-shape self-expandable metal stent has been used for gastroenteral (gastrojejunal) and bilioenteric (cholecysto-gastric, choledocoduodenal) anastomosis in clinical practice with promising results [31]. A recent case control retrospective trial has demonstrated its role compared to traditional endoscopic stenting in managing gastric outlet obstruction from malignant and benign conditions [32].

#### 9. Summary

Gastrointestinal stenting is a procedure associated to a high safety and technical success profile, and its clinical indications have surpassed its original use, esophageal cancer. Self-expandable metal stent placement is the preferred nonsurgical method for biliopancreatic and upper and lower gastrointestinal tract cancer palliation. Stenting is also being used for several other indications, such as benign gastrointestinal stricture treatment, gastrointestinal fistula management, variceal bleeding arrest, and gastrointestinal bypass or drainage. Several efforts have been made to overcome its three remaining clinical major issues: stent occlusion, stent migration, and stent-related perforation.

Author details

Stents in Gastrointestinal Diseases

DOI: http://dx.doi.org/10.5772/intechopen.88117

89

Eduardo Aimore Bonin\*, Bruno Verschoor, Fernanda Hoffmann Silva,

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium,

Kelly Cristina Vieira and Susan Kakitani Takata Hospital Erasto Gaertner, Curitiba, Paraná, Brazil

provided the original work is properly cited.

\*Address all correspondence to: eabonin@gmail.com

Stents in Gastrointestinal Diseases DOI: http://dx.doi.org/10.5772/intechopen.88117

### Author details

This totally covered, dumbbell-shape self-expandable metal stent has been used for gastroenteral (gastrojejunal) and bilioenteric (cholecysto-gastric, choledocoduodenal) anastomosis in clinical practice with promising results [31]. A recent case control retrospective trial has demonstrated its role compared to traditional endoscopic stenting in managing gastric outlet obstruction from malignant and benign

Lumen-apposing self-expandable metal stent used for transgastric drainage of a walled of pancreatic necrosis. (a) Four weeks after transgastric endoscopic necrosectomy, the resulting cavity has been replaced by granulating tissue. The stent was then removed. The stent has large flanges to avoid migration (b) and a 14 mm lumen to

Gastrointestinal stenting is a procedure associated to a high safety and technical success profile, and its clinical indications have surpassed its original use, esophageal cancer. Self-expandable metal stent placement is the preferred nonsurgical method for biliopancreatic and upper and lower gastrointestinal tract cancer palliation. Stenting is also being used for several other indications, such as benign gastrointestinal stricture treatment, gastrointestinal fistula management, variceal bleeding arrest, and gastrointestinal bypass or drainage. Several efforts have been made to overcome its three remaining clinical major issues: stent occlusion, stent

conditions [32].

Figure 8.

Advanced Endoscopy

9. Summary

88

migration, and stent-related perforation.

allow endoscope insertion (c). Picture from Eduardo A. Bonin.

Eduardo Aimore Bonin\*, Bruno Verschoor, Fernanda Hoffmann Silva, Kelly Cristina Vieira and Susan Kakitani Takata Hospital Erasto Gaertner, Curitiba, Paraná, Brazil

\*Address all correspondence to: eabonin@gmail.com

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

#### References

[1] Available from: https://www.merria m-webster.com/dictionary/stent#h1m [Accessed: April 30, 2019]

[2] Roguin A. Stent: The man and word behind the coronary metal prosthesis. Circulation Cardiovascular Interventions. 2011;4(2):206-209

[3] Girardet RE, Ransdell HT Jr, Wheat MW Jr. Palliative intubation in the management of esophageal carcinoma. The Annals of Thoracic Surgery. 1974; 18(4):417-430

[4] Symonds CJ. The treatment of malignant stricture of the oesophagus by tubage or permanent catheterism. British Medical Journal. 1887;1(1373): 870-873

[5] Irani S, Kozarek RA. History of GI stenting: Rigid prostheses in the esophagus. In: Kozarek RA, Baron TH, Song HY, editors. Self-Expandable Stents in the GI Tract. New York, USA: Springer; 2013. pp. 3-15. ISBN 978-1- 4614-3745-1

[6] Knyrim K, Wagner HJ, Bethge N, Keymling M, Vakil N. A controlled trial of an expansile metal stent for palliation of esophageal obstruction due to inoperable cancer. The New England Journal of Medicine. 1993;329(18): 1302-1307

[7] Thiebes AL, McGrath DJ, Kelly N, Sweeney CA, Kurtenbach K, Gesché VN, et al. Comparison of covered laser-cut and braided respiratory stents: From bench to preclinical testing. Annals of Biomedical Engineering. 2019;47(8):1738-1747

[8] Domingo S, Puértolas S, Gracia-Villa L, Puértolas JA. Mechanical comparative analysis of stents for colorectal obstruction. Minimally Invasive

Therapy & Allied Technologies. 2007; 16(2):126-136

Endoscopy. Clinical Endoscopy. 2013;

DOI: http://dx.doi.org/10.5772/intechopen.88117

Schattner MA. Carcinomatosis is not a contraindication to enteral stenting in selected patients with malignant gastric outlet obstruction. Gastrointestinal Endoscopy. 2011;73(6):1135-1140

[22] Bonin EA, Baron TH. Preoperative biliary stents in pancreatic cancer. Journal of Hepato-Biliary-Pancreatic

Sciences. 2011;18(5):621-629

910-930

416-426

990-1053

193-208

2010;12(5):374-382

[23] Dumonceau JM, Tringali A, Papanikolaou IS, Blero D,

Mangiavillano B, Schmidt A, et al. Endoscopic biliary stenting: Indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline—Updated October 2017. Endoscopy. 2018;50(9):

[24] Arezzo A, Passera R, Lo Secco G, Verra M, Bonino MA, Targarona E, et al. Stent as bridge to surgery for left-sided malignant colonic obstruction reduces adverse events and stoma rate compared with emergency surgery: Results of a systematic review and meta-analysis of

Gastrointestinal Endoscopy. 2017;86:

[25] Bonin EA, Baron TH. Update on the indications and use of colonic stents. Current Gastroenterology Reports.

[26] van Hooft JE, van Halsema EE, Vanbiervliet G, Beets-Tan RG, DeWitt JM, Donnellan F, et al. Selfexpandable metal stents for obstructing colonic and extracolonic cancer: Clinical guideline. Endoscopy. 2014;46(11):

[27] Ribeiro IB, de Moura DTH, Thompson CC, de Moura EGH. Acute abdominal obstruction: Colon stent or emergency surgery? An evidence-based

Gastrointestinal Endoscopy. 2019;11(3):

review. World Journal of

randomized controlled trials.

Siersema PD, Fuccio L, Schumacher B, Escorsell À, et al. Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy. 2016;48(10):939-948

[15] Spaander MC, Baron TH,

Stents in Gastrointestinal Diseases

[16] Kang HW, Kim SG. Upper gastrointestinal stent insertion in malignant and benign disorders. Clinical

Endoscopy. 2015;48(3):187-193

[17] Pandit S, Samant H, Morris J, Alexander SJ. Efficacy and safety of standard and anti-reflux self-expanding metal stent: A systematic review and meta-analysis of randomized controlled trials. World Journal of Gastrointestinal

Endoscopy. 2019;11(4):271-280

Zhou J, et al. Interventions for dysphagia in oesophageal cancer. Cochrane Database of Systematic Reviews. 2014;10:CD005048

Vleggaar FP, et al. Surgical

placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): A multicenter randomized trial. Gastrointestinal Endoscopy. 2010;71(3):490-499

outlet obstruction caused by

with good performance status: Endoscopic stenting versus surgery. Gastrointestinal Endoscopy. 2013;78(1):

[21] Mendelsohn RB, Gerdes H, Markowitz AJ, DiMaio CJ,

55-62

91

[18] Dai Y, Li C, Xie Y, Liu X, Zhang J,

[19] Jeurnink SM, Steyerberg EW, van Hooft JE, van Eijck CH, Schwartz MP,

gastrojejunostomy or endoscopic stent

[20] No JH, Kim SW, Lim CH, Kim JS, Cho YK, Park JM, et al. Long-term outcome of palliative therapy for gastric

unresectable gastric cancer in patients

46(4):342-354

[9] Mangiavillano B, Pagano N, Baron TH, Arena M, Iabichino G, Consolo P, et al. Biliary and pancreatic stenting: Devices and insertion techniques in therapeutic endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography. World Journal of Gastrointestinal Endoscopy. 2016;8(3):143-156

[10] Shatzel J, Kim J, Sampath K, Syed S, Saad J, Hussain ZH, et al. Drug eluting biliary stents to decrease stent failure rates: A review of the literature. World Journal of Gastrointestinal Endoscopy. 2016;8(2):77-85. DOI: 10.4253/wjge.v8. i2.77

[11] Samadder NJ, Bonin EA, Buttar NS, Baron TH, Gostout CJ, Topazian MD, et al. Placement of a covered stent for palliation of a cavitated colon cancer by using a novel over-the-scope technique (with video). Gastrointestinal Endoscopy. 2012;76(6):1275-1277

[12] Veld JV, Fockens P, van Hooft JE. Mistakes in enteral stenting and how to avoid them. UEG Education. 2019;19: 5-8

[13] Fujii LL, Bonin EA, Baron TH, Gostout CJ, Wong Kee Song LM. Utility of an endoscopic suturing system for prevention of covered luminal stent migration in the upper GI tract. Gastrointestinal Endoscopy. 2013;78(5): 787-793

[14] Jee SR, Cho JY, Kim KH, Kim SG, Cho JH, The Stent Study Group of the Korean Society of Gastrointestinal Endoscopy. Evidence-based recommendations on upper gastrointestinal tract stenting: A report from the Stent Study Group of the Korean Society of Gastrointestinal

Stents in Gastrointestinal Diseases DOI: http://dx.doi.org/10.5772/intechopen.88117

Endoscopy. Clinical Endoscopy. 2013; 46(4):342-354

References

Advanced Endoscopy

18(4):417-430

870-873

4614-3745-1

1302-1307

90

[1] Available from: https://www.merria m-webster.com/dictionary/stent#h1m

Therapy & Allied Technologies. 2007;

[10] Shatzel J, Kim J, Sampath K, Syed S, Saad J, Hussain ZH, et al. Drug eluting biliary stents to decrease stent failure rates: A review of the literature. World Journal of Gastrointestinal Endoscopy. 2016;8(2):77-85. DOI: 10.4253/wjge.v8.

[11] Samadder NJ, Bonin EA, Buttar NS, Baron TH, Gostout CJ, Topazian MD, et al. Placement of a covered stent for palliation of a cavitated colon cancer by using a novel over-the-scope technique

[12] Veld JV, Fockens P, van Hooft JE. Mistakes in enteral stenting and how to avoid them. UEG Education. 2019;19:

[13] Fujii LL, Bonin EA, Baron TH, Gostout CJ, Wong Kee Song LM. Utility of an endoscopic suturing system for prevention of covered luminal stent migration in the upper GI tract.

Gastrointestinal Endoscopy. 2013;78(5):

[14] Jee SR, Cho JY, Kim KH, Kim SG, Cho JH, The Stent Study Group of the Korean Society of Gastrointestinal Endoscopy. Evidence-based recommendations on upper

gastrointestinal tract stenting: A report from the Stent Study Group of the Korean Society of Gastrointestinal

(with video). Gastrointestinal Endoscopy. 2012;76(6):1275-1277

[9] Mangiavillano B, Pagano N, Baron TH, Arena M, Iabichino G, Consolo P, et al. Biliary and pancreatic

stenting: Devices and insertion techniques in therapeutic endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography. World Journal of Gastrointestinal Endoscopy.

16(2):126-136

2016;8(3):143-156

i2.77

5-8

787-793

[2] Roguin A. Stent: The man and word behind the coronary metal prosthesis.

[3] Girardet RE, Ransdell HT Jr, Wheat MW Jr. Palliative intubation in the management of esophageal carcinoma. The Annals of Thoracic Surgery. 1974;

[4] Symonds CJ. The treatment of malignant stricture of the oesophagus by tubage or permanent catheterism. British Medical Journal. 1887;1(1373):

[5] Irani S, Kozarek RA. History of GI stenting: Rigid prostheses in the esophagus. In: Kozarek RA, Baron TH, Song HY, editors. Self-Expandable Stents in the GI Tract. New York, USA: Springer; 2013. pp. 3-15. ISBN 978-1-

[6] Knyrim K, Wagner HJ, Bethge N, Keymling M, Vakil N. A controlled trial of an expansile metal stent for palliation

[7] Thiebes AL, McGrath DJ, Kelly N,

respiratory stents: From bench to preclinical testing. Annals of Biomedical Engineering. 2019;47(8):1738-1747

[8] Domingo S, Puértolas S, Gracia-Villa L, Puértolas JA. Mechanical comparative

analysis of stents for colorectal obstruction. Minimally Invasive

Sweeney CA, Kurtenbach K, Gesché VN, et al. Comparison of covered laser-cut and braided

of esophageal obstruction due to inoperable cancer. The New England Journal of Medicine. 1993;329(18):

[Accessed: April 30, 2019]

Circulation Cardiovascular Interventions. 2011;4(2):206-209 [15] Spaander MC, Baron TH, Siersema PD, Fuccio L, Schumacher B, Escorsell À, et al. Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy. 2016;48(10):939-948

[16] Kang HW, Kim SG. Upper gastrointestinal stent insertion in malignant and benign disorders. Clinical Endoscopy. 2015;48(3):187-193

[17] Pandit S, Samant H, Morris J, Alexander SJ. Efficacy and safety of standard and anti-reflux self-expanding metal stent: A systematic review and meta-analysis of randomized controlled trials. World Journal of Gastrointestinal Endoscopy. 2019;11(4):271-280

[18] Dai Y, Li C, Xie Y, Liu X, Zhang J, Zhou J, et al. Interventions for dysphagia in oesophageal cancer. Cochrane Database of Systematic Reviews. 2014;10:CD005048

[19] Jeurnink SM, Steyerberg EW, van Hooft JE, van Eijck CH, Schwartz MP, Vleggaar FP, et al. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): A multicenter randomized trial. Gastrointestinal Endoscopy. 2010;71(3):490-499

[20] No JH, Kim SW, Lim CH, Kim JS, Cho YK, Park JM, et al. Long-term outcome of palliative therapy for gastric outlet obstruction caused by unresectable gastric cancer in patients with good performance status: Endoscopic stenting versus surgery. Gastrointestinal Endoscopy. 2013;78(1): 55-62

[21] Mendelsohn RB, Gerdes H, Markowitz AJ, DiMaio CJ,

Schattner MA. Carcinomatosis is not a contraindication to enteral stenting in selected patients with malignant gastric outlet obstruction. Gastrointestinal Endoscopy. 2011;73(6):1135-1140

[22] Bonin EA, Baron TH. Preoperative biliary stents in pancreatic cancer. Journal of Hepato-Biliary-Pancreatic Sciences. 2011;18(5):621-629

[23] Dumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, et al. Endoscopic biliary stenting: Indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline—Updated October 2017. Endoscopy. 2018;50(9): 910-930

[24] Arezzo A, Passera R, Lo Secco G, Verra M, Bonino MA, Targarona E, et al. Stent as bridge to surgery for left-sided malignant colonic obstruction reduces adverse events and stoma rate compared with emergency surgery: Results of a systematic review and meta-analysis of randomized controlled trials. Gastrointestinal Endoscopy. 2017;86: 416-426

[25] Bonin EA, Baron TH. Update on the indications and use of colonic stents. Current Gastroenterology Reports. 2010;12(5):374-382

[26] van Hooft JE, van Halsema EE, Vanbiervliet G, Beets-Tan RG, DeWitt JM, Donnellan F, et al. Selfexpandable metal stents for obstructing colonic and extracolonic cancer: Clinical guideline. Endoscopy. 2014;46(11): 990-1053

[27] Ribeiro IB, de Moura DTH, Thompson CC, de Moura EGH. Acute abdominal obstruction: Colon stent or emergency surgery? An evidence-based review. World Journal of Gastrointestinal Endoscopy. 2019;11(3): 193-208

[28] Ngamruengphong S, Sharaiha R, Sethi A, Siddiqui A, DiMaio CJ, Gonzalez S, et al. Fully-covered metal stents with endoscopic suturing vs. partially-covered metal stents for benign upper gastrointestinal diseases: A comparative study. Endoscopy International Open. 2018;6(2): E217-E223

[29] Rao AS, LeRoy AJ, Bonin EA, Sweetser SR, Baron TH. Novel technique for placement of overlapping self-expandable metal stents to close a massive pancreatitis-induced duodenal fistula. Endoscopy. 2012;44(Suppl 2 UCTN):E163-E164

[30] Hadj Amor WB, Bonin EA, Vitton V, Desjeux A, Grimaud JC, Barthet M. Successful endoscopic management of large upper gastrointestinal perforations following EMR using over-the-scope clipping combined with stenting. Endoscopy. 2012;44(Suppl 2 UCTN):E277

[31] Lee HS, Chung MJ. Past, present, and future of gastrointestinal stents: New endoscopic ultrasonographyguided metal stents and future developments. Clinical Endoscopy. 2016;49(2):131-138

[32] Chen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, et al. EUSguided gastroenterostomy is comparable to enteral stenting with fewer reinterventions in malignant gastric outlet obstruction. Surgical Endoscopy. 2017; 31(7):2946-2952

[28] Ngamruengphong S, Sharaiha R, Sethi A, Siddiqui A, DiMaio CJ, Gonzalez S, et al. Fully-covered metal stents with endoscopic suturing vs. partially-covered metal stents for benign upper gastrointestinal diseases: A comparative study. Endoscopy International Open. 2018;6(2):

[29] Rao AS, LeRoy AJ, Bonin EA, Sweetser SR, Baron TH. Novel

[30] Hadj Amor WB, Bonin EA, Vitton V, Desjeux A, Grimaud JC, Barthet M. Successful endoscopic management of large upper

gastrointestinal perforations following EMR using over-the-scope clipping combined with stenting. Endoscopy. 2012;44(Suppl 2 UCTN):E277

[31] Lee HS, Chung MJ. Past, present, and future of gastrointestinal stents: New endoscopic ultrasonographyguided metal stents and future developments. Clinical Endoscopy.

[32] Chen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, et al. EUSguided gastroenterostomy is comparable to enteral stenting with fewer reinterventions in malignant gastric outlet obstruction. Surgical Endoscopy. 2017;

technique for placement of overlapping self-expandable metal stents to close a massive pancreatitis-induced duodenal fistula. Endoscopy. 2012;44(Suppl 2

E217-E223

Advanced Endoscopy

UCTN):E163-E164

2016;49(2):131-138

31(7):2946-2952

92

## *Edited by Qiang Yan and Xu Sun*

With the rapid development of modern medical technology, endoscopic technology has also achieved unprecedented development. Its fields cover examination, treatment, surgery, and even molecular imaging diagnosis. Endoscopy technology brings a minimally invasive diagnosis and treatment experience to patients. Invasive treatment and examination of digestive surgery has changed from large incisions to several Trocar holes, from surgery to endoscopic treatment, and from laparotomy to endoscopy or laparoscopy, which has changed the diagnosis treatment and management of digestive surgery, enhanced the recovery after surgery, and benefited the patients needing to undergo surgical procedures. It is for this reason that we plan to introduce the development of endoscopic and laparoscopic surgery in digestive surgery and enhanced rehabilitation medicine.

Published in London, UK © 2020 IntechOpen © Eraxion / iStock

Advanced Endoscopy

Advanced Endoscopy

*Edited by Qiang Yan and Xu Sun*