Digestive Endoscopy 2014; 26 (Suppl. 1): 95–104

doi: 10.1111/den.12191

Review

Endoscopic clip closure of gastrointestinal perforations, fistulae, and leaks Gottumukkala S. Raju Department of Gastroenterology, Hepatology, and Nutrition, University of Texas MD Anderson Cancer Center, Houston, USA

Development of endoscopic devices to close perforations has certainly revolutionized endoscopy. Immediate closure of perforations eliminates the need for surgery, which allows us to push the limits of endoscopic surgery from the mucosal plane to deep submucosal layers and eventually transmurally. The present

Key words: clip, fistula, leak, perforation, suture

INTRODUCTION

TYPES OF ENDOSCOPIC CLOSURE

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NDOSCOPIC CLIP CLOSURE of perforations marks the beginning of a new era of endoluminal surgery. It allows us to close perforations immediately, thereby eliminating the need for surgery and the morbidity and mortality associated with it. Professor Nib Soehendra’s group’s first successful closure of a gastric perforation after endoscopic resection of a leiomyoma opened up the field of endoscopic surgery.1 In the present article, I review endoscopic devices and closure techniques, and both animal and clinical studies on endoscopic closure of perforations.

article focuses on endoscopic closure devices, closure techniques, followed by a review of animal and clinical studies on endoscopic closure of perforations.

NLIKE THE SURGICAL parallel suture closure of perforations, endoscopic closure results in either an inverted or an everted closure (Fig. 1). • Inverted closure: Flexible staplers, OTSC and TTSC devices (QuickClip, Resolution clip, and Instinct Clip) result in an inverted closure. • Everted closure: T-tags result in an everted closure.

CLOSURE DEVICES

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URRENTLY AVAILABLE CLIPS can be delivered through the endoscope (through-the-scope clips: TTSC): Quick Clip (Olympus America Inc., Center Valley, PA, USA), Resolution Clip (Boston Scientific Inc., Natick, MA, USA) and Instinct Clip (Cook Medical Inc., Bloomington, IN, USA) or over the scope (over-the-scope clip: OTSC system; Ovesco Endoscopy AG, Tübingen, Germany).

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Corresponding: Gottumukkala S. Raju, Department of Gastroenterology, Hepatology, and Nutrition, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1466, Houston, USA. Email: [email protected] Received 9 April 2013; accepted 17 September 2013.

Figure 1 Types of closure. (Upper left panel) perforation; (upper right panel) parallel suture surgical closure; (lower left panel) inverted clip closure; (lower right panel) everted T-tag closure. Reproduced with permission from the American Society of Gastrointestinal Endoscopy.

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Inverted closure with OTSC or TTSC devices is routinely used in clinical practice, whereas flexible staplers and T-tags are not yet available for routine patient care.

Inverted closure: OTSC and TTSC TTSC have been available in the market for a couple of decades, whereas the concept of OTSC is relatively new. Experimental studies on clip closure of perforations laid the foundation for their successful use in clinical practice.2–4

Digestive Endoscopy 2014; 26 (Suppl. 1): 95–104

Endoscopic suturing has been shown to be successful in the closure of a submucosal tunnel created for endoscopic full-thickness gastric biopsy for analysis of neuromuscular cells.32 Full-thickness transgastric and transduodenal myotomy followed by suture closure could be used to create endoscopic pyloroplasty in animal experiments.36 Using a novel multifunctional prototype (EndoSAMURAI; Olympus, Tokyo, Japan), transgastric small bowel segmental resection followed by end-to-end small bowel anastomosis could be successfully carried out in animal studies.37

EXPERIMENTAL STUDIES

Colon Perforation Closure

Esophageal Perforation Closure

Through-the-scope clips and sutures

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In porcine survival studies, endoscopic through-the-scope clip closure demonstrated successful healing of 1.5–2-cm colon perforation and leak-proof sealing of linear as well as circular perforations. In addition, peritonitis can be avoided and adhesions lessened compared to surgical closure.38–42 In ex-vivo porcine colonic model studies, TTSC resulted in excellent closure of an 18-mm perforation, comparable to hand-sewn parallel closure (gold standard) on air leak pressure testing.22,43 However, TTSC failed in closing gaping perforations with sloping edges.39–41 Through-the-scope suturing devices (T-tags) to bring gaping wide perforations together could be used for successful closure of gaping linear perforations and full-thickness resection of the colon; this could be a potential option for management of polyps tethered to the underlying wall that do not lift after submucosal injection.42,44,45 Although T-tag closure resulted in successful approximation of the edges, everted suture closure was inferior to surgical closure;22,43 peritoneal soiling through the gaps between the T-tag sutures resulted in peritonitis.42 Another concern was inadvertent puncture of adjacent organs during T-tag insertion.42 Through-the-scope suturing devices are not currently approved for clinical use. Successful clip closure of colotomy allowed exploration of the possibility of transcolonic small bowel resection using a combination of NOTES and laparoscopy.46

XPERIMENTAL STUDIES DEMONSTRATED the feasibility of endoscopic closure of esophageal perforations as well as the submucosal esophageal tunnel openings after peroral esophageal myotomy; the latter technique led to a novel endoscopic treatment option for achalasia.5–7 A randomized controlled animal survival study demonstrated that endoscopic clip and suture closures are comparable to thoracoscopic closure of esophageal perforations.8 In addition, successful suture closure of endoscopic full-thickness esophageal resection defects was possible; however, some of the animals developed tension pneumothorax and mediastinal infection.5

Gastric Perforation Closure Kalloo and his colleagues explored the possibility of endoscopic exploration of the peritoneal cavity through the stomach wall, followed by successful clip closure of the gastric perforation at the end of the procedure – this opened up a new field in medicine – natural orifice transluminal endoscopic surgery (NOTES).9 Subsequently, several investigators confirmed endoscopic closure of gastric wall openings (ports of entry) for gastric NOTES, defects from full-thickness resection of the gastric wall to study motility disorders of the stomach, rents left after removal of gastric subepithelial tumors, and mouths of submucosal tunnels in porcine models.10–32 Approximation of the edges of small perforations with clips or using an omental patch clip closure can be used for successful closure of the majority of the perforations.33 Failure of closure could precipitate peritonitis.33 TTSC devices are limited to closure of smaller gastric perforations (10 mm), whereas OTSC result in successful closure of 15-mm perforations; although closure of 20-mm gastric perforations is possible, the burst pressures in such cases are lower than those achieved with closure of smaller perforations. Gastric perforations >20 mm are not amenable to closure with a single OTSC.34 Perforations in the fundus of the stomach could be closed successfully with an OTSC.35

Over-the-scope clip Ex-vivo porcine colonic model studies using OTSC devices produced results comparable to hand-sewn parallel closure (gold standard) when air leak pressures were tested immediately after closure.22,43 Colon perforations of 5 ± 10 mm on the serosal side were successfully closed with OTSC devices, with an uneventful clinical course for 12 weeks.47 In a randomized controlled animal trial of acute closure strengths of 18-mm colonic perforations, OTSC devices achieved results comparable to surgical suture closures. However, the risk of suctioning adjacent tissue, especially adjacent intestine into the closure was a concern.48 A single OTSC device resulted in an excellent, full-thickness closure

© 2013 The Author Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society

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of colon perforations up to 25 mm; although adequate closure of up to 30-mm perforations in the colon was possible, the burst pressures in such cases were lower than those achieved with smaller perforations.34 Endoscopic closure of perforations permitted endoscopic full-thickness resection of the colon to study the myenteric plexus and neuromuscular transmission in the colon.49

Over-the-scope suturing device Although similar results were accomplished with the use of an endoscopic suturing machine (Eagle Claw; Apollo Endosurgery Inc. Austin, TX, USA), closure was technically challenging in some cases.50

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Although the technique of OTSC application is simple and straightforward, it is important to follow the steps carefully to close a perforation, as follows. Align the lesion in a 6 to 12 o’clock position, if possible. 1. Grasp all layers of the GI wall, including the serosa, with the Twin Grasper positioned in the center of each perforation edge. 2. Withdraw the grasper with the tissue into the center of the distal cap to assure that the entire perforation site is within the clips’ reach. Caution: avoid capturing of the Twin Grasper by the clip. 3. Suction to pull a sufficient amount of tissue surrounding the lesion into the cap.34

CLOSURE TECHNIQUES

CLINICAL STUDIES

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Once the clip is opened, rotate the blades to align them at right angles to the defect and engage the lower blade to the lower edge of a transverse perforation. Then, gently push the clip–endoscope unit while applying gentle suction to collapse the lumen so that the opposite edge of the perforation can be grasped as deeply as possible while the clip is slowly closed.

REVIEW OF THE literature on the endoscopic closure of gastrointestinal perforations a decade ago was encouraging.51 Several reported successful clip closures of perforations, fistulas, and anastomotic leaks of the esophagus, stomach, duodenum, and colon resulting from a wide variety of causes (endoscopy,52 endoscopic ultrasonography,53 colonoscopy,54 dilation of an esophageal stricture,52 balloon dilation of an anastomotic stricture,55 pneumatic balloon dilation of achalasia,55 percutaneous endoscopic gastrostomy placement,56 biliary sphincterotomy,57 biliary stent migration,58 snare polypectomy,1 endoscopic mucosal resection (EMR),59,60 ampullectomy,57 foreign body ingestion,61,62 Boerhaave’s syndrome,52 diverticulitis,63 appendiceal abscess,64 empyema,65 and postoperative anastomotic leaks66,67). Our knowledge on this subject has certainly evolved.3,4,68

Longitudinal perforations

Closure of esophageal perforations and fistulae

T IS IMPORTANT to learn perforation closure techniques with the TTSC and OTSC devices. The following paragraphs describe the various techniques used.

Closure technique: TTSC Keep the clip close to the end of the endoscope to maneuver the clip–endoscope as a single unit.

Transverse perforation closure

Start at the top end of the perforation and apply the clip just above the upper end of a longitudinal perforation to pucker the edges below for easier application of subsequent clips. Clips are placed from the top down to close longitudinal perforations starting away from the endoscope and working towards the endoscope or left-to-right for closure of circular or transverse perforations.

Closure technique: OTSC The OTSC system (Ovesco Endoscopy AG, Tübingen, Germany) is a super-elastic, nitinol clip that is biocompatible and compatible with magnetic resonance imaging. It is mounted on a clear distal cap at the end of an endoscope and deployed by turning a wheel on the shaft of the endoscope, similar to the mechanism used for band ligation. The OTSC clip creates full-thickness closure by using teeth arranged in the shape of a bear trap.

Endoscopic clips allow successful closure of perforations and fistulas. Preliminary reports on TTSC closure of esophageal perforations are encouraging.52 Endoscopic closure of esophageal EMR perforations increased the wide adoption of non-surgical options for esophageal dysplasia and cancer.69 Where esophageal stents are unsuitable for management of proximal and distal esophageal perforations, clips can be used successfully.70 In a detailed review of endoscopic clip closure of 17 patients resulting from endoscopy (65%), foreign bodies or food impactions (18%), and Boerhaave’s syndrome (12%), endoscopic clips were successful in the closure of 10-mm perforations. For every 10-day increase in the duration of a perforation, healing time increased by 8 days.71 Emerging data on OSTC closure of esophageal perforations and fistulas are encouraging.72–76 A multicenter

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European cohort study reported the outcome of OTSC on 36 consecutive patients with acute iatrogenic perforations of the gastrointestinal tract

Endoscopic clip closure of gastrointestinal perforations, fistulae, and leaks.

Development of endoscopic devices to close perforations has certainly revolutionized endoscopy. Immediate closure of perforations eliminates the need ...
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