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Endoscopic Management of Gastrointestinal Leaks and Fistulae
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Endoscopic Management of Gastrointestinal Leaks and Fistulae Q7
Field F. Willingham* and Jonathan M. Buscaglia‡ *Division of Digestive Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; and ‡Division of Gastroenterology, Department of Medicine, Stony Brook University School of Medicine, Stony Brook, New York Gastrointestinal leaks and fistulae can be serious acute complications or chronic morbid conditions resulting from inflammatory, malignant, or postsurgical states. Endoscopic closure of gastrointestinal leaks and fistulae represents major progress in the treatment of patients with these complex presentations. The main goal of endoscopic therapy is the interruption of the flow of luminal contents across a gastrointestinal defect. In consideration of the proper endoscopic approach to luminal closure, several basic principles must be considered. Undrained cavities and fluid collections must often first be drained percutaneously, and the percutaneous drain provides an important measure of safety for subsequent endoscopic luminal manipulations. The size and exact location of the leak/ fistula, as well as the viability of the surrounding tissue, must be defined. Almost all complex leaks and fistulae must be approached in a multidisciplinary manner, collaborating with colleagues in nutrition, radiology, and surgery. Currently, gastrointestinal leaks and fistulae may be managed endoscopically by using 1 or more of the following modalities: stent placement, clip closure (including through-the-scope clips and over-the-scope devices), endoscopic suturing, and the injection of tissue sealants. In this article, we discuss these modalities and review the published outcomes data regarding each approach as well as practical considerations for successful closure of luminal defects. Keywords: Gastrointestinal Fistula; Gastrointestinal Leak; Endoscopy; Stenting; OTSC.
uccessful endoscopic closure of gastrointestinal (GI) leaks and fistulae has dramatically changed our approach to managing patients with complex, abnormal communications involving the upper and lower GI tract. What can be associated with devastating consequences and extensive postsurgical morbidity may now frequently be managed by using advanced endoscopic closure techniques. One of the earliest reports in this area is nearly 25 years old and involved a fibrin tissue adhesive applied under endoscopic guidance to occlude an anastomotic dehiscence for 7 patients with high-output postoperative enterocutaneous fistulae.1 Shortly thereafter, Binmoeller et al2 reported the first successful closure of an acute gastric perforation by using metallic clips immediately after resection of a gastric leiomyoma. Although perforations may differ from chronic leaks and fistulae, the concept of endoscopic
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repair was put forward in the early 1990s with reports such as these. Not only did they change the way we think about such patients, but they facilitated industry’s response to the development of more advanced endoscopic tools. Specifically, improved clipping devices and removable self-expanding plastic stents (SEPS) were born from such early successful reports. Roughly 15 years later in 2006, Merrifield et al3 published a brief series of 3 patients with chronic gastric leaks after Rouxen-Y gastric bypass surgery for weight loss. All 3 patients were successfully managed without the need for reoperation by using a combination endoscopic approach with hemoclips, fibrin glue, and SEPS placement. During the past decade there has been a dramatic increase in published reports of successful endoscopic treatment of GI leaks and fistulae. Although few randomized, comparative trials exist, experience in managing such patients by endoscopic means has grown immensely. New devices have prompted further research, and more research has further pushed device development. Currently, GI leaks and fistulae are being managed endoscopically by using 1 or more of 4 different methods. These include stent placement, clip closure (both through-the-scope clips [TTSCs] and overthe-scope clips [OTSCs]), endoscopic suturing, and the injection of tissue sealants. The intent of this article is to provide an overview on the management with each method and to familiarize the reader on the current status that is based on recent publications and author experience. This article covers luminal GI leaks; pancreatic duct and biliary leaks are managed with different techniques and are not covered in this review. Broadly speaking, there are several requirements to enable endoscopic approaches to the closure of leaks and fistulae. The endoscopist must be familiar with the interpretation of radiographic and fluoroscopic imaging. Locating and defining the precise site of the leak are a critical and sometimes challenging first step. Upper GI
Abbreviations used in this paper: APC, argon plasma coagulation; FCSEMS, fully covered self-expanding metal stents; GI, gastrointestinal; OTSC, over-the-scope clip; PCSEMS, partially covered self-expanding metal stents; SEMS, self-expanding stents; SEPS, self-expanding plastic stents; TTSC, through-the-scope clip. © 2015 by the AGA Institute 1542-3565/$36.00 http://dx.doi.org/10.1016/j.cgh.2015.02.010
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Table 1. ---
Total patients included in study Total patients with leaks/fistulae No. of stents placed overall No. of stents placed for leaks/fistulae Stent type(s) used Overall technical success rate (%) Overall stent migration rate (%) Short-term closure of leak/fistula (%) Long-term closure of leak/fistula
Bakken et al16 2010
Senousy et al17 2010
Eloubeidi et al6 2011
56 22 104 47 AliMaxx-E FCSEMS 93 28 38 —
14 7 28 — AliMaxx-E FCSEMS 100 39 86 —
35 12 35a 12a AliMaxx-E FCSEMS 100 34 — 44
Buscaglia et al7 2011 31 15 43 24 Wallflex FCSEMSb 100 33 80 —
El Hajj et al18 2014 54 44 117 100 SEPS, PCSEMS, FCSEMSc 100 28 74 83
—, no specific data available. a Further data on total number of stents used are not available; manuscript notes 14 patients overall required repeat stenting, with 3 patients in the leak/perforation group. b Wallflex (Boston Scientific Inc, Natick, MA) FCSEMS used in 30 of 43 stents placed. c Multiple types of stents used, including Ultraflex/Polyflex/Wallflex (Boston Scientific Inc) and AlliMaxx-E (Alveolus Inc).
contrast radiography by using barium or Gastrografin is frequently performed to confirm the presence of a disruption. In semiacute or chronic fistulae, patients have often had percutaneous catheters placed by interventional radiology to drain cavities and fluid collections. In this scenario, dye such as methylene blue may be infused within the gut lumen; its identification in the drainage catheter confirms persistent leakage from the fistula site. Similarly, contrast can be injected during the procedure to confirm the leak fluoroscopically. Carbon dioxide (CO2) should be used for insufflation, because passage of the insufflating gas across the luminal disruption into the peritoneum or mediastinum is likely to occur. After endoscopic closure, contrast studies such as a Gastrografin esophagogram should be performed to assess the adequacy of the closure. This is often repeated on followup to confirm continued integrity of the seal.
Endoscopic Stent Placement Stent placement for the treatment of leaks and fistulae has mostly been restricted to luminal disruptions within the upper GI tract. The reasons for this are multifold. First, the purpose of stent placement is to cover the region of leakage so that GI secretions (and sometimes food) may be diverted away from the point of incompetency. The goal is to provide a temporary barricade to the region and to prevent the influx of enzymatic fluid through the opening. As a result, covered (presumably removable) stents are preferred. The major limitation with covered stents is their propensity for migration, which occurs in at least 25% of patients when used for this indication, regardless of the choice of SEPS or self-expanding metal stents (SEMS).4–7 Distal stent migration into an intact stomach rarely passes beyond the pylorus; therefore, intestinal obstruction and the need for surgical removal are uncommon. Likewise, a
competent gastrojejunal anastomosis in a patient with a gastric pouch from a Roux-en-Y bypass also tends to preclude downstream distal migration. The increased motility of the lower GI tract, however, allows for easy stent migration both distally and proximally. This not only prevents fistula closure but also increases the chances of obstruction, perforation, and other migrationrelated events. In addition, until recently, most commercially available covered stents are not deployed by using through-the-scope delivery catheters. Therefore, stent placement is performed over a wire under fluoroscopic guidance. This can be especially challenging in situations such as those requiring passage of the stent delivery catheter through the left colon under fluoroscopic guidance alone or alongside endoscopic guidance. Postoperative leaks after esophagectomy and gastrectomy are not infrequent, occurring in approximately 7%–8% of cases when performed for the treatment of esophageal or gastric cancer.8,9 Mortality rates can exceed 50% for both types of operations if the diagnosis is delayed.8–10 Leak rates after bariatric surgical procedures appear to be somewhat less common, reported in up to 5.2% of patients undergoing Roux-en-Y bypass and 2.4% after sleeve gastrectomy.11–13 Temporary stent placement with SEPS in an attempt to heal such postoperative leaks and fistulae began to be reported around 2005. Langer et al14 first described their experience by using the Polyflex SEPS (Boston Scientific Inc, Marlborough, MA) for patients with leaks after esophagectomy and gastrectomy. Initial leak occlusion with the ability to resume oral feeding was quite good, but late stent migration was observed in 50% of patients. Experience by using the Polyflex grew considerably during the next several years before 2010,4,5,15 yet aside from its high rate of migration, additional practical issues with the stent hampered its widespread adoption. For example, the need for pre-deployment assembly, as well as the stiffness of the stent and large-size delivery
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catheter, made it difficult to use the Polyflex in many patients. To circumvent these issues, some moved toward using partially covered self-expanding metal stents (PCSEMS) as a treatment option; yet tissue ingrowth at the proximal and distal uncovered portions of these stents can create challenges for subsequent removal. Therefore, the need for a fully covered alternative was born, and published reports surfaced describing the use of fully covered self-expanding metal stents (FCSEMS) to temporarily treat upper GI tract leaks and fistulae. Table 1 summarizes the major findings for 5 of the most notable studies assessing the performance of esophageal stent placement in patients with leaks/ fistulae during the past 5 years. Bakken et al16 were one of the initial groups to report their experience by using FCSEMS for benign esophageal disease, specifically for the treatment of esophageal leaks or fistulae, as well as benign strictures. In their series of 56 patients, 22 had an esophageal FCSEMS inserted for a leak/fistula. The AliMaxx-E stent (Alveolus Inc, Charlotte, NC) was used exclusively. Stents were left in place for approximately 80 days in this group. The rate of stent migration was 28%, usually leading to reintervention before scheduled removal. All of the stents were successfully retrieved. Seven of 22 patients (32%) showed initial improvement of their leak; however, long-term follow-up of these patients was mostly lacking. Senousy et al17 published a similar study in 2010, yet with far fewer patients. Only 7 of the 14 patients had an esophageal stent placed for the treatment of a fistula/leak. Again, the AliMaxx-E stent was used exclusively. Resolution of the fistula/leak was seen in 6 of 7 patients (86%). Stent migration was noted in nearly 40% of patients. There was no long-term follow-up reported (Table 1). Buscaglia et al7 described their experience inserting a range of different types of FCSEMS for benign esophageal indications, including leaks and fistulae (Figure 1). A total of 15 patients had stents placed to treat a leak/ fistula, and most were positioned in the proximal esophagus within 2 cm of the upper esophageal sphincter (10 of 15, 66.7%). In the 24 stents placed, 8 stents (33.3%) migrated. Nearly all cases of stent migration occurred within 30 days of insertion. All stents were able to be successfully removed. Again, long-term data were lacking, but the majority of patients (80%)
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had initial radiographic resolution of their leak/fistula. Eloubeidi et al6 published a similar report describing 12 patients with an esophageal leak/fistula. Long-term success with complete resolution was seen in 44% of patients. Recently in 2014, a more comprehensive review and analysis of patients treated with esophageal stents inserted specifically for the treatment of leaks, fistulae, and perforations was published by El Hajj et al.18 In their study of 54 patients, they examined the factors associated with complete closure after index stent removal (defined as primary closure) or after further endoscopic stenting (defined as secondary closure). The study collected data during a 9-year period of time; thus, multiple stent types were used including SEPS, PCSEMS, and FCSEMS. Forty-four of the 54 patients were treated for a leak or fistula and 10 patients for an acute perforation. A total of 100 stents were placed in the 44 patients with leaks/fistulae. Overall, the rate of stent migration for the entire study was 28%. Primary closure was achieved in 74% of patients, including the 10 patients treated for perforation. Secondary closure was achieved in 83% of patients. The authors noted that significant factors associated with primary closure included a smaller luminal/defect opening size and shorter time between diagnosis and stent insertion (Table 1). The success in treating acute leaks after bariatric surgery appears to be quite good with use of both SEPS and SEMS. In 2012, Puli et al19 published a meta-analysis of 7 studies examining the resolution rate with stent insertion. Stents were left in place for 4–8 weeks. The rate of complete closure after stent removal (with radiographic confirmation) was 87.8%. Overall stent migration was noted in 16.9%. Only 9% of the patients required surgical revision. In an effort to avoid distal stent migration into the Roux limb for bariatric surgery patients, the use of PCSEMS has been used to allow tissue ingrowth at the proximal and distal ends of the stent (uncovered portions) to anchor it in place.20 Migration rates appear to be lower in this scenario, but removal of the stent may be a challenge. Alazmi et al21 published a retrospective series of 17 patients with acute leaks after laparoscopic sleeve gastrectomy. PCSEMS were placed initially to treat
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Figure 1. (A) Small tracheo-gastric fistula after transhiatal esophagectomy with gastric pull-up; (B) endoclips used to close the fistula; (C) covered SEMS inserted across the anastomosis and deployed to cover the fistula site; (D) fluoroscopic view with arrow showing metal endoclips at site of closure.
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the leaks for a median of 42 days. Then SEPS were inserted inside the PCSEMS to allow for pressure necrosis of the ingrown edges of the PCSEMS (a technique previously reported by Eisendrath et al20). Both stents were successfully removed at a median of 11 days later. Leak closure after stent removal was observed in 13 of 17 patients (76%). An alternative to this stent-in-stent technique for the removal of PCSEMS may be to use argon plasma coagulation (APC) for the ablation of ingrown tissue at the stent borders. APC at standard power settings can destroy the ingrown tissue, thereby exposing the underlying metal interstices of the uncovered portions of the stent. Once the stent borders are freed, the PCSEMS can be removed in typical fashion. Additional strategies to avoid stent migration include insertion of FCSEMS, with endoclips deployed at the proximal stent border to fasten the stent to the mucosa. More recently, the Apollo OverStitch device (Apollo Endosurgery, Austin, TX) may be used to suture the proximal end of the stent in place. There are limited safety and efficacy data available at this point that report on any of these alternative methods. Cases of colonic stent placement for the successful treatment of lower GI tract leaks and fistulae are less commonly reported. The high likelihood of stent migration within the colon makes stent placement a less viable option. However, some groups have reported successful use of covered esophageal SEMS and covered biodegradable esophageal stents (not available in the United States) for the purpose of treating colorectal fistulae in small series.22,23
Clip Closure Although endoscopic stenting and diversion of the luminal stream are often helpful, stent migration can be an issue as previously described. Some leaks are not in regions that are easily bypassed with an enteral stent. Especially with small leaks, endoscopic closure may be performed by using various endoscopic clips. Multiple small-capacity through-the-scope clips (TTSCs) are at times used to sequentially close luminal disruptions. Newer OTSCs (OTSC System; Ovesco Endoscopy AG, Tubingen, Germany) obtain a much larger bite, bringing a larger region of tissue into approximation. The OTSC device is a nitinol-based metal clip that at opening is packaged on a plastic cap. The cap is designed to fit over the tip of the endoscope. The cap is affixed, and a thread is brought through the working channel of the endoscope. The thread is attached to a wheel-operated deployment device that inserts into the working channel cap on the handle of the endoscope. The assembly and deployment are similar to those used for variceal banding and endoscopic mucosal resection. The region of interest is suctioned into the cap, and the clip is then deployed, approximating the edges. Care must be taken to ensure that both edges are within the cap; clips
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improperly deployed onto the edge of a lesion may make subsequent attempts at closure more challenging. For this reason, the OTSC device also contains 2 types of grasping forceps that can be inserted through the scope (and thus through the cap) to pull both edges of the tissue into the cap before the clip is released (Video 1). For endoscopic clip–based closures, the tissue surrounding the leak or fistula must be robust enough to be held within the jaws of the clips. If the tissue is weak, friable, or necrotic, the clip may incise the mucosa without bringing the edges into approximation. An endoscopic examination before the attempted closure is frequently indicated to evaluate the quality of the tissue surrounding the fistula or leak. There have been multiple reports of the use of OTSCs for closure of fistulae. One series covering multiple clip applications described the use of the OTSC in 11 perforations and 8 GI fistulae. In the setting of perforations, all 11 were closed with no recurrence. In the setting of fistulae, primary closure was achieved in all 8; however, there was a recurrence in 5 patients.24 Another small series of 4 patients described the use of the OTSC for chronic fistulae. Again highlighting the importance of the quality of the tissue surrounding the leak, the closure was successful in 2 patients; yet in the other 2 patients with fibrotic changes or scarring at the fistula site, the closure was unsuccessful.25 In another series of 12 patients, OTSC clip closure was successful in 11 of 12 patients, with repositioning required in 1 additional patient.26 A case report of the management of a gastrocolic fistula also described successful endoscopic closure of the fistulous communication by using an OTSC.27 In a larger case series of 14 acute and chronic colorectal postsurgical leaks and fistulae, OTSC closure was successful in 86% (acute, 87% [7 of 8] and chronic, 83% [5 of 6]). Surgery was required in 1 patient, and no OTSCrelated complications were reported.28 Novel applications such as the use of endoscopic vacuum therapy, akin to the concept of a wound vacuum, with or without OTSC closures have been reviewed.29 Another retrospective series has been reported on 30 patients treated for fistulae by using the OTSC device. Of the 30 patients, 19 (63%) had a gastric fistula after laparoscopic sleeve gastrectomy, and the overall success rate was 71%.30 In a series of varying applications (including 6 fistulae and 1 anastomotic leak), the overall success rate by using the OTSC was 75%.31 Overall, the OTSC devices enable reliable closure of larger defects, and studies suggest that a substantial number of leaks and fistulae can be successfully managed with this endoscopic approach. Assuming that the mucosa is robust enough for clipbased closure, there is limited evidence that abrasion of the tissue edges before approximation may help the tissue seal together and fuse. This concept was suggested in an animal model32 and has also been described in several other reports of closures.3,33 In our practice, we perform an initial endoscopic and fluoroscopic
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evaluation. The site is identified, and the quality of the tissue surrounding the fistula is assessed. The leakage and communication are confirmed by contrast fluoroscopy or with the use of dye. Once the findings have been reviewed and the options discussed, an endoscopic closure may be considered. The tissue edges and surrounding areas are ablated with APC. A cytology brush is then used to abrade the lateral aspects. If applicable, the OTSC device can then be deployed to bring the edges into approximation. Contrast is injected, filling the lumen in the region of the leak, and the adequacy of the closure is inspected in real time. Any ongoing leak may be managed by further clipping or stenting as described above.
Endoscopic Suturing Other endoscopic approaches to the closure of GI fistulae may involve the application of endoscopic suturing systems. Endoscopic suturing is significantly more difficult from a technical aspect than the application of clipping devices. However, suturing systems may be capable of closing larger defects. Suturing requires additional training and considerable expertise on the part of the endoscopist. The same concerns described regarding the quality of the tissue surrounding the area of leak apply with endoscopic suturing. The tissue must be sufficiently healthy and strong to hold the sutures and not tear or incise when the sutures are cinched and the tissue is pulled toward apposition. In one of the largest series to date, the authors compared endoscopic suturing with endoscopic clipping for the management of gastro-gastric fistulae after Roux-en-Y gastric bypass. There were 95 total patients, and 71 received endoscopic suturing (EndoCinch; C. R. Bard, Inc, Murray Hill, NJ).33 The mean size of the fistula was significantly larger in the suturing group. The initial results were promising, with 95% of patients achieving complete primary closure; however, fistula site reopening was seen in 65%. None of the larger fistulae (initial size, >20 mm) remained closed during the follow-up period, although approximately one-third of patients (32%) with initial fistula size 10 mm achieved long-term closure. In a series with similar outcomes, an endoscopic system for tissue apposition (with antecedent mucosal ablation) was used for 4 patients with 5 gastro-gastric fistulae. The mucosal ablation was performed to produce a raw surface by using needleknife cautery, snares, and hot/cold biopsy graspers to promote fusion when the lateral aspects were brought into contact. There was excellent success in achieving primary closure (100%); however, after 3 months, only the smallest fistula (initially 10 mm) remained completely closed, and at 6 months, it also revealed a visible pinhole-sized opening.34 The data to date show good results with initial fistula closure. For long-term closure, however, the best results for gastro-gastric
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fistulae are seen with fistulae 10 mm in diameter. Overall, with gastric fistulae after bariatric surgery, durability may be limited. With other types of fistulae, there are case series of successful closure by using suturing systems. An esophagopleural fistula was successfully closed by using multiple techniques including stenting, glue, and 2 sessions of endoscopic suturing.35 In abstract form, 6 patients were described with 1 esophagomediastinal, 3 gastrocutaneous, and 2 bronchoesophageal fistulae.36 The esophagomediastinal fistula was treated with stenting (sutured in place). The 3 patients with gastrocutaneous fistulae were closed with interrupted and running sutures in 2 separate layers. One developed dehiscence at 10 days after procedure and was then closed again by using a second suturing session. The 2 patients with bronchoesophageal fistulae were closed, but dehiscence of the sutures occurred and required multiple repeat suturing sessions (3 and 4) before complete closure. Endoscopic suturing is an appealing concept for its ability to closely mimic surgical closure techniques. The currently available systems have evolved during the past decade, but further refinement is necessary to improve the technical feasibility of the procedure for most therapeutic endoscopists and to allow for greater application of use.
Tissue Sealants One of the first reports on successful fistula closure by means of an endoscopic technique used fibrin glue injected into the aberrant openings of patients with high-output enterocutaneous fistulae.1 Since then, several reports have been published on the success of using tissue sealants in this regard. Both fibrin glue and cyanoacrylate have been used with moderate success.37–39 The sites of application mostly include areas of anastomotic leakage after esophagectomy and gastrectomy or after bariatric surgical procedures (eg, esophagogastric anastomoses or gastrojejunal anastomoses, respectively). Typically, the mucosa around the opening of the fistula is de-epithelialized so that when the site is plugged or closed with a combination of clips and sealant, there is a reactive inflammatory response around the opening that promotes complete sealing. As noted, this can be accomplished by using a standard biliary cytology brush to gently abrade the edges of the fistula. Also, APC at low power settings can be used for this purpose. Application of the tissue sealant is usually performed with a double-lumen catheter inserted down the working channel of the endoscope, because both components of the sealant (eg, fibrin glue) begin to react and form a bond immediately on contact. The larger lumen of the catheter should be reserved for the more viscous component.10 As reported previously by Kumar and Thompson,10 rapid exchange/short-wire
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double-lumen endoscopic retrograde cholangiopancreatography catheters should not be used, because the sealant may leak out the sides of the catheter and damage the endoscope channel. High-output GI fistulae are less likely to successfully close with the use of tissue sealant alone.40 Combination therapy by using clips and covered stents along with glue appears to be more successful.3,37 For larger openings, Vicryl mesh plugs or soft tissue grafting material such as Surgisis (Cook Inc, West Lafayette, IN) may be used to fill in the gaps before glue injection or in combination with clip application and stent placement.41 Long-term success with complete fistula closure is welldocumented in small series that use these combined methods.42
Discussion GI leaks and fistulae may be acute and lifethreatening or may become chronic and clinically debilitating. Fistulae may occur spontaneously between organs because of inflammatory conditions or malignancy, or they may be the result of GI surgeries such as organ resection or bariatric procedures. Anastomotic leaks may complicate 5%–30% of esophageal anastomoses9,43,44 and 5%–15% of rectal anastomoses.45–47 Some leaks may potentially be managed conservatively. Such initial trials often involve diet restriction, no feeding above the leak, parenteral nutrition, antibiotics, and percutaneous catheter–based approaches to provide drainage of fluid collections. Addressing nutrition is often a key step in enabling the patient to heal the fistulous communication, either with or without the application of endoscopic closure techniques. Although the sections in this review have been separated by technique, quite commonly a combination of different techniques is applied together. For example, an esophagogastric fistula may be best managed with tissue abrasion, fibrin glue injection, and endoscopic clip closure, followed by esophageal stent placement over the fistula site to divert the luminal stream. Regardless of the specific techniques used, there are several overriding principles that apply to all patients undergoing endoscopic closure of leaks and fistulae. First, almost all patients will require multispecialty involvement. Care should be delivered by a team that will typically involve advanced endoscopy, surgery, interventional radiology, and nutrition. Second, definition and delineation of the site of the leak are critical. This is often aided by contrast radiology studies. Third, if a fluid collection or cavity exists, insertion of percutaneous drainage catheter before endoscopic closure should be strongly considered. The injection of contrast and the insufflation of gas into a non-drained space can create major complications and infections. Fourth, careful evaluation of the quality of the tissue surrounding the leak/fistula is important.
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The quality of the tissue surrounding the defect is often critical in determining which closure technique is best applied. Fifth, the main goal of endoscopic therapy is the interruption of the flow of luminal contents across the defect. Ongoing flow tends to maintain the patency of the defect, and a method of interrupting the flow (eg, clip closure device, stent placement, tissue adhesive, etc) is a key step in promoting closure. Sixth, the adequacy of the closure should be studied ideally at the time of the procedure, after the closure, and in followup to confirm continued integrity. Use contrast radiography to assess for ongoing leak and also expect that a sound closure should be evidenced by decreasing volumes and negligible output via the percutaneous drain over time. In conclusion, advanced endoscopic methods are enabling less invasive and more physiological approaches for the management of GI leaks and fistulae. A multidisciplinary approach is a critical component in developing the correct treatment pathway; some leaks and fistulae are not amenable to endoscopic closure. For those that are, endoscopic closures represent significant progress in the minimally invasive management of GI leaks and fistulae.
Supplementary Material Note: To access the supplementary material accompanying this article, visit the online version of Clinical Gastroenterology and Hepatology at www.cghjournal.org, and at http://dx.doi.org/10.1016/j.cgh.2015.02.010.
References 1. Eleftheriadis E, Tzartinoqlou E, Kotzampassi K, et al. Early endoscopic fibrin sealing of high-output postoperative enterocutaneous fistulas. Acta Chir Sand 1990;156:625–628. 2. Binmoeller KF, Grimm H, Soehendra N. Endoscopic closure of a perforation using metallic clips after snare excision of a gastric leiomyoma. Gastrointest Endosc 1993;39:172–174. 3. Merrifield BF, Lautz D, Thompson CC. Endoscopic repair of gastric leaks after Roux-en-Y gastric bypass: a less invasive approach. Gastrointest Endosc 2006;63:710–714. 4. Freeman RK, Ascioti AJ, Wozniak TC. Postoperative esophageal leak management with the Polyflex esophageal stent. J Thorac Cardiovasc Surg 2007;133:333–338. 5. Fukomoto R, Orlina J, McGinty J, et al. Use of Polyflex stents in treatment of acute esophageal and gastric leaks after bariatric surgery. Surg Obes Relat Dis 2007;3:68–71. 6. Eloubeidi MA, Talreja JP, Lopes TL, et al. Success and complications associated with placement of fully-covered removable self-expandable metal stents for benign esophageal diseases. Gastrointest Endosc 2011;73:673–681. 7. Buscaglia JM, Ho S, Sethi A, et al. Fully-covered selfexpandable metal stents for benign esophageal disease: a multicenter retrospective case series of 31 patients. Gastrointest Endosc 2011;74:207–211. 8. Rutegard M, Lagergren P, Pouvelas I, et al. Intrathoracic anastomotic leakage and mortality after esophageal cancer
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27. Mönkemüller K, Peter S, Alkurdi B, et al. Endoscopic closure of a gastrocolic fistula using the over-the-scope-clip-system. World J Gastrointest Endosc 2013;5:402–406.
10. Kumar N, Thomson CC. Endoscopic therapy for postoperative leaks and fistulae. Gastrointest Endosc Clin N Am 2013; 23:123–136. 11. Morales MP, Miedema BW, Scott JS, et al. Management of postsurgical leaks in the bariatric patient. Gastrointest Endosc Clin N Am 2011;21:295–304.
28. Arezzo A, Verra M, Reddavid R, et al. Efficacy of the over-thescope clip (OTSC) for treatment of colorectal postsurgical leaks and fistulas. Surg Endosc 2012;26:3330–3333. 29. Mennien R, Senninger N, Laukoetter MG. Novel treatment options for perforations of the upper gastrointestinal tract: endoscopic vacuum therapy and over-the-scope clips. World J Gastroenterol 2014;20:7767–7776.
12. Aurora AR, Khaitan L, Saber AA. Sleeve gastrectomy and the risk of leak: a systematic analysis of 4,888 patients. Surg Endosc 2012;26:1509–1515. 13. Sakran N, Goitein D, Raziel A, et al. Gastric leaks after sleeve gastrectomy: a multicenter experience with 2834 patients. Surg Endosc 2013;27:240–245. 14. Langer FB, Wenzl E, Prager G, et al. Management of postoperative esophageal leaks with the Polyflex self-expanding covered plastic stent. Ann Thorac Surg 2005;79:398–403. 15. Karbowski M, Schembre D, Kozarek R, et al. Polyflex selfexpanding, removable plastic stents: assessment of treatment efficacy and safety in a variety of benign and malignant conditions of the esophagus. Surg Endosc 2008;22:1326–1333.
30. Mercky P, Gonzalez JM, Aimore BE, et al. Usefulness of overthe-scope clipping system for closing digestive fistulas. Dig Endosc 2015;27:18–24. 31. Mönkemüller K, Peter S, Toshniwal J, et al. Multipurpose use of the ‘bear claw’ (over-the-scope-clip system) to treat endoluminal gastrointestinal disorders. Dig Endosc 2014; 26:350–357. 32. Felsher J, Farres H, Chand B, et al. Mucosal apposition in endoscopic suturing. Gastrointest Endosc 2003;58:867–870. 33. Fernandez-Esparrach G, Lautz DB, Thompson CC. Endoscopic repair of gastrogastric fistula after Roux-en-Y gastric bypass: a less-invasive approach. Surg Obes Relat Dis 2010; 6:282–288.
16. Bakken JC, Wong Kee Song LM, de Groen PC, et al. Use of a fully covered self-expandable metal stent for the treatment of benign esophageal diseases. Gastrointest Endosc 2010; 72:712–720.
34. Spaun GO, Marinec DV, Kennedy TJ, et al. Endoscopic closure of gastrogastric fistulas by using a tissue apposition system (with videos). Gastrointest Endosc 2010;71:606–611.
17. Senousy BE, Gupte AR, Draganov PV, et al. Fully covered Alimaxx esophageal metal stents in the endoscopic treatment of benign esophageal diseases. Dig Dis Sci 2010;55:3399–3403.
35. Bonin EA, Wong Kee Song LM, Gostout ZS, et al. Closure of a persistent esophagopleural fistula assisted by a novel endoscopic suturing system. Endoscopy 2012;44:E8–E9.
18. 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. Gastrointest Endosc 2014;79:589–598.
36. Catalano MF, Sorser SA, Henderson JB, et al. 810 successful closure of enteric fistulas using the Apollo Overstitch Suturing System. Gastroenterology 2014;146:S-142–S-143.
19. Puli SR, Spofford IS, Thompson CC. Use of self-expandable stents in the treatment of bariatric surgery leaks: a systematic review and meta-analysis. Gastrointest Endosc 2012;75:287–293. 20. Eisendrath P, Cremer M, Himpens J, et al. Endotherapy including temporary stenting of fistulas of the upper gastrointestinal tract after laparoscopic bariatric surgery. Endoscopy 2007;39:625–630. 21. Alazmi W, Al-Sabah S, Ali DA, et al. Treating sleeve gastrectomy leak with endoscopic stenting: the Kuwaiti experience and reQ5 view of the literature. Surg Endosc 2014. 22. Qandeel H, Abudeeb H, Hammad A, et al. Colonic stent and percutaneous ethanol injection as a treatment for colocutaneous fistula secondary to benign stricture. J Surg Case Rep 2012; 2012:2. 23. Perez Roldan F, Gonzalez Carro P, Villafanez Garcia MC, et al. Usefulness of biodegradable polydioxanone stents in the treatment of postsurgical colorectal strictures and fistulas. Endoscopy 2012;44:297–300. 24. Kirschniak A, Subotova N, Zieker D, et al. The Over-The-Scope Clip (OTSC) for the treatment of gastrointestinal bleeding, perforations, and fistulas. Surg Endosc 2011;25:2901–2905. 25. von Renteln D, Denzer UW, Schachschal G, et al. Endoscopic closure of GI fistulae by using an over-the-scope clip (with videos). Gastrointest Endosc 2010;72:1289–1296. 26. Manta R, Manno M, Bertani H, et al. Endoscopic treatment of gastrointestinal fistulas using an over-the-scope clip (OTSC)
37. Victorzon M, Victorzon S, Peromaa-Haavisto P. Fibrin glue and stents in the treatment of gastrojejunal leaks after laparoscopic gastric bypass: a case series and review of the literature. Obes Surg 2013;23:1692–1697. 38. Farra J, Zhuge Y, Neville HL, et al. Submucosal fibrin glue injection for closure of recurrent tracheoesophageal fistula. Pediatr Surg Int 2010;26:237–240. 39. Pramateftakis MG, Vrakas G, Kanellos I, et al. Endoscopic application of n-butyl-2-cyanoacrylate on esophagojejunal anastomotic leak: a case report. J Med Case Rep 2011; 5:96. 40. Rabago LR, Ventosa N, Castro JL, et al. Endoscopic treatment of postoperative fistulas resistant to conservative management using biological fibrin glue. Endoscopy 2002;34:632–638. 41. Tringali A, Daniel FB, Familiari P, et al. Endoscopic treatment of recalcitrant esophageal fistula with new tools: stents, Surgisis and nitinol staples. Gastrointest Endosc 2010;72: 647–650. 42. Bohm G, Mossdorf A, Klink C, et al. Treatment algorithm for postoperative upper gastrointestinal fistulas and leaks using combined vicryl plug and fibrin glue. Endoscopy 2010; 42:599–602. 43. Lee Y, Fujita H, Yamana H, et al. Factors affecting leakage following esophageal anastomosis. Surgery Today 1994;24:24–29. 44. Miller JD, Jain MK, de Gara CJ, et al. Effect of surgical experience on results of esophagectomy for esophageal carcinoma. J Surg Oncol 1997;65:20–21.
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45. Nesbakken A, Nygaard K, Lunde OC, et al. Anastomotic leak following mesorectal excision for rectal cancer: true incidence and diagnostic challenges. Colorectal Dis 2005;7:576–581. 46. Lee WS, Yun SH, Roh YN, et al. Risk factors and clinical outcome for anastomotic leakage after total mesorectal excision for rectal cancer. World J Surg 2008;32:1124–1129. 47. Eckmann C, Kujath P, Schiedeck TH, et al. Anastomotic leakage following low anterior resection: results of a standardized diagnostic and therapeutic approach. Int J Colorectal Dis 2004; 19:128–133.
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Reprint requests Address requests for reprints to: Field F. Willingham, MD, MPH, Emory University Hospital, 1364 Clifton Road NE, Atlanta, Georgia 30322. e-mail: field. Q2 [email protected]; fax: (404) 778-2925. Conflicts of interest The authors disclose no conflicts.
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Funding Supported in part by a development grant from the Department of Medicine at Q4 Emory University School of Medicine.
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Endoscopic Management of Gastrointestinal Leaks and Fistulae Q7
Field F. Willingham* and Jonathan M. Buscaglia‡ *Division of Digestive Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; and ‡Division of Gastroenterology, Department of Medicine, Stony Brook University School of Medicine, Stony Brook, New York Gastrointestinal leaks and fistulae can be serious acute complications or chronic morbid conditions resulting from inflammatory, malignant, or postsurgical states. Endoscopic closure of gastrointestinal leaks and fistulae represents major progress in the treatment of patients with these complex presentations. The main goal of endoscopic therapy is the interruption of the flow of luminal contents across a gastrointestinal defect. In consideration of the proper endoscopic approach to luminal closure, several basic principles must be considered. Undrained cavities and fluid collections must often first be drained percutaneously, and the percutaneous drain provides an important measure of safety for subsequent endoscopic luminal manipulations. The size and exact location of the leak/ fistula, as well as the viability of the surrounding tissue, must be defined. Almost all complex leaks and fistulae must be approached in a multidisciplinary manner, collaborating with colleagues in nutrition, radiology, and surgery. Currently, gastrointestinal leaks and fistulae may be managed endoscopically by using 1 or more of the following modalities: stent placement, clip closure (including through-the-scope clips and over-the-scope devices), endoscopic suturing, and the injection of tissue sealants. In this article, we discuss these modalities and review the published outcomes data regarding each approach as well as practical considerations for successful closure of luminal defects. Keywords: Gastrointestinal Fistula; Gastrointestinal Leak; Endoscopy; Stenting; OTSC.
uccessful endoscopic closure of gastrointestinal (GI) leaks and fistulae has dramatically changed our approach to managing patients with complex, abnormal communications involving the upper and lower GI tract. What can be associated with devastating consequences and extensive postsurgical morbidity may now frequently be managed by using advanced endoscopic closure techniques. One of the earliest reports in this area is nearly 25 years old and involved a fibrin tissue adhesive applied under endoscopic guidance to occlude an anastomotic dehiscence for 7 patients with high-output postoperative enterocutaneous fistulae.1 Shortly thereafter, Binmoeller et al2 reported the first successful closure of an acute gastric perforation by using metallic clips immediately after resection of a gastric leiomyoma. Although perforations may differ from chronic leaks and fistulae, the concept of endoscopic
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repair was put forward in the early 1990s with reports such as these. Not only did they change the way we think about such patients, but they facilitated industry’s response to the development of more advanced endoscopic tools. Specifically, improved clipping devices and removable self-expanding plastic stents (SEPS) were born from such early successful reports. Roughly 15 years later in 2006, Merrifield et al3 published a brief series of 3 patients with chronic gastric leaks after Rouxen-Y gastric bypass surgery for weight loss. All 3 patients were successfully managed without the need for reoperation by using a combination endoscopic approach with hemoclips, fibrin glue, and SEPS placement. During the past decade there has been a dramatic increase in published reports of successful endoscopic treatment of GI leaks and fistulae. Although few randomized, comparative trials exist, experience in managing such patients by endoscopic means has grown immensely. New devices have prompted further research, and more research has further pushed device development. Currently, GI leaks and fistulae are being managed endoscopically by using 1 or more of 4 different methods. These include stent placement, clip closure (both through-the-scope clips [TTSCs] and overthe-scope clips [OTSCs]), endoscopic suturing, and the injection of tissue sealants. The intent of this article is to provide an overview on the management with each method and to familiarize the reader on the current status that is based on recent publications and author experience. This article covers luminal GI leaks; pancreatic duct and biliary leaks are managed with different techniques and are not covered in this review. Broadly speaking, there are several requirements to enable endoscopic approaches to the closure of leaks and fistulae. The endoscopist must be familiar with the interpretation of radiographic and fluoroscopic imaging. Locating and defining the precise site of the leak are a critical and sometimes challenging first step. Upper GI
Abbreviations used in this paper: APC, argon plasma coagulation; FCSEMS, fully covered self-expanding metal stents; GI, gastrointestinal; OTSC, over-the-scope clip; PCSEMS, partially covered self-expanding metal stents; SEMS, self-expanding stents; SEPS, self-expanding plastic stents; TTSC, through-the-scope clip. © 2015 by the AGA Institute 1542-3565/$36.00 http://dx.doi.org/10.1016/j.cgh.2015.02.010
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Table 1. ---
Total patients included in study Total patients with leaks/fistulae No. of stents placed overall No. of stents placed for leaks/fistulae Stent type(s) used Overall technical success rate (%) Overall stent migration rate (%) Short-term closure of leak/fistula (%) Long-term closure of leak/fistula
Bakken et al16 2010
Senousy et al17 2010
Eloubeidi et al6 2011
56 22 104 47 AliMaxx-E FCSEMS 93 28 38 —
14 7 28 — AliMaxx-E FCSEMS 100 39 86 —
35 12 35a 12a AliMaxx-E FCSEMS 100 34 — 44
Buscaglia et al7 2011 31 15 43 24 Wallflex FCSEMSb 100 33 80 —
El Hajj et al18 2014 54 44 117 100 SEPS, PCSEMS, FCSEMSc 100 28 74 83
—, no specific data available. a Further data on total number of stents used are not available; manuscript notes 14 patients overall required repeat stenting, with 3 patients in the leak/perforation group. b Wallflex (Boston Scientific Inc, Natick, MA) FCSEMS used in 30 of 43 stents placed. c Multiple types of stents used, including Ultraflex/Polyflex/Wallflex (Boston Scientific Inc) and AlliMaxx-E (Alveolus Inc).
contrast radiography by using barium or Gastrografin is frequently performed to confirm the presence of a disruption. In semiacute or chronic fistulae, patients have often had percutaneous catheters placed by interventional radiology to drain cavities and fluid collections. In this scenario, dye such as methylene blue may be infused within the gut lumen; its identification in the drainage catheter confirms persistent leakage from the fistula site. Similarly, contrast can be injected during the procedure to confirm the leak fluoroscopically. Carbon dioxide (CO2) should be used for insufflation, because passage of the insufflating gas across the luminal disruption into the peritoneum or mediastinum is likely to occur. After endoscopic closure, contrast studies such as a Gastrografin esophagogram should be performed to assess the adequacy of the closure. This is often repeated on followup to confirm continued integrity of the seal.
Endoscopic Stent Placement Stent placement for the treatment of leaks and fistulae has mostly been restricted to luminal disruptions within the upper GI tract. The reasons for this are multifold. First, the purpose of stent placement is to cover the region of leakage so that GI secretions (and sometimes food) may be diverted away from the point of incompetency. The goal is to provide a temporary barricade to the region and to prevent the influx of enzymatic fluid through the opening. As a result, covered (presumably removable) stents are preferred. The major limitation with covered stents is their propensity for migration, which occurs in at least 25% of patients when used for this indication, regardless of the choice of SEPS or self-expanding metal stents (SEMS).4–7 Distal stent migration into an intact stomach rarely passes beyond the pylorus; therefore, intestinal obstruction and the need for surgical removal are uncommon. Likewise, a
competent gastrojejunal anastomosis in a patient with a gastric pouch from a Roux-en-Y bypass also tends to preclude downstream distal migration. The increased motility of the lower GI tract, however, allows for easy stent migration both distally and proximally. This not only prevents fistula closure but also increases the chances of obstruction, perforation, and other migrationrelated events. In addition, until recently, most commercially available covered stents are not deployed by using through-the-scope delivery catheters. Therefore, stent placement is performed over a wire under fluoroscopic guidance. This can be especially challenging in situations such as those requiring passage of the stent delivery catheter through the left colon under fluoroscopic guidance alone or alongside endoscopic guidance. Postoperative leaks after esophagectomy and gastrectomy are not infrequent, occurring in approximately 7%–8% of cases when performed for the treatment of esophageal or gastric cancer.8,9 Mortality rates can exceed 50% for both types of operations if the diagnosis is delayed.8–10 Leak rates after bariatric surgical procedures appear to be somewhat less common, reported in up to 5.2% of patients undergoing Roux-en-Y bypass and 2.4% after sleeve gastrectomy.11–13 Temporary stent placement with SEPS in an attempt to heal such postoperative leaks and fistulae began to be reported around 2005. Langer et al14 first described their experience by using the Polyflex SEPS (Boston Scientific Inc, Marlborough, MA) for patients with leaks after esophagectomy and gastrectomy. Initial leak occlusion with the ability to resume oral feeding was quite good, but late stent migration was observed in 50% of patients. Experience by using the Polyflex grew considerably during the next several years before 2010,4,5,15 yet aside from its high rate of migration, additional practical issues with the stent hampered its widespread adoption. For example, the need for pre-deployment assembly, as well as the stiffness of the stent and large-size delivery
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catheter, made it difficult to use the Polyflex in many patients. To circumvent these issues, some moved toward using partially covered self-expanding metal stents (PCSEMS) as a treatment option; yet tissue ingrowth at the proximal and distal uncovered portions of these stents can create challenges for subsequent removal. Therefore, the need for a fully covered alternative was born, and published reports surfaced describing the use of fully covered self-expanding metal stents (FCSEMS) to temporarily treat upper GI tract leaks and fistulae. Table 1 summarizes the major findings for 5 of the most notable studies assessing the performance of esophageal stent placement in patients with leaks/ fistulae during the past 5 years. Bakken et al16 were one of the initial groups to report their experience by using FCSEMS for benign esophageal disease, specifically for the treatment of esophageal leaks or fistulae, as well as benign strictures. In their series of 56 patients, 22 had an esophageal FCSEMS inserted for a leak/fistula. The AliMaxx-E stent (Alveolus Inc, Charlotte, NC) was used exclusively. Stents were left in place for approximately 80 days in this group. The rate of stent migration was 28%, usually leading to reintervention before scheduled removal. All of the stents were successfully retrieved. Seven of 22 patients (32%) showed initial improvement of their leak; however, long-term follow-up of these patients was mostly lacking. Senousy et al17 published a similar study in 2010, yet with far fewer patients. Only 7 of the 14 patients had an esophageal stent placed for the treatment of a fistula/leak. Again, the AliMaxx-E stent was used exclusively. Resolution of the fistula/leak was seen in 6 of 7 patients (86%). Stent migration was noted in nearly 40% of patients. There was no long-term follow-up reported (Table 1). Buscaglia et al7 described their experience inserting a range of different types of FCSEMS for benign esophageal indications, including leaks and fistulae (Figure 1). A total of 15 patients had stents placed to treat a leak/ fistula, and most were positioned in the proximal esophagus within 2 cm of the upper esophageal sphincter (10 of 15, 66.7%). In the 24 stents placed, 8 stents (33.3%) migrated. Nearly all cases of stent migration occurred within 30 days of insertion. All stents were able to be successfully removed. Again, long-term data were lacking, but the majority of patients (80%)
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had initial radiographic resolution of their leak/fistula. Eloubeidi et al6 published a similar report describing 12 patients with an esophageal leak/fistula. Long-term success with complete resolution was seen in 44% of patients. Recently in 2014, a more comprehensive review and analysis of patients treated with esophageal stents inserted specifically for the treatment of leaks, fistulae, and perforations was published by El Hajj et al.18 In their study of 54 patients, they examined the factors associated with complete closure after index stent removal (defined as primary closure) or after further endoscopic stenting (defined as secondary closure). The study collected data during a 9-year period of time; thus, multiple stent types were used including SEPS, PCSEMS, and FCSEMS. Forty-four of the 54 patients were treated for a leak or fistula and 10 patients for an acute perforation. A total of 100 stents were placed in the 44 patients with leaks/fistulae. Overall, the rate of stent migration for the entire study was 28%. Primary closure was achieved in 74% of patients, including the 10 patients treated for perforation. Secondary closure was achieved in 83% of patients. The authors noted that significant factors associated with primary closure included a smaller luminal/defect opening size and shorter time between diagnosis and stent insertion (Table 1). The success in treating acute leaks after bariatric surgery appears to be quite good with use of both SEPS and SEMS. In 2012, Puli et al19 published a meta-analysis of 7 studies examining the resolution rate with stent insertion. Stents were left in place for 4–8 weeks. The rate of complete closure after stent removal (with radiographic confirmation) was 87.8%. Overall stent migration was noted in 16.9%. Only 9% of the patients required surgical revision. In an effort to avoid distal stent migration into the Roux limb for bariatric surgery patients, the use of PCSEMS has been used to allow tissue ingrowth at the proximal and distal ends of the stent (uncovered portions) to anchor it in place.20 Migration rates appear to be lower in this scenario, but removal of the stent may be a challenge. Alazmi et al21 published a retrospective series of 17 patients with acute leaks after laparoscopic sleeve gastrectomy. PCSEMS were placed initially to treat
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Figure 1. (A) Small tracheo-gastric fistula after transhiatal esophagectomy with gastric pull-up; (B) endoclips used to close the fistula; (C) covered SEMS inserted across the anastomosis and deployed to cover the fistula site; (D) fluoroscopic view with arrow showing metal endoclips at site of closure.
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the leaks for a median of 42 days. Then SEPS were inserted inside the PCSEMS to allow for pressure necrosis of the ingrown edges of the PCSEMS (a technique previously reported by Eisendrath et al20). Both stents were successfully removed at a median of 11 days later. Leak closure after stent removal was observed in 13 of 17 patients (76%). An alternative to this stent-in-stent technique for the removal of PCSEMS may be to use argon plasma coagulation (APC) for the ablation of ingrown tissue at the stent borders. APC at standard power settings can destroy the ingrown tissue, thereby exposing the underlying metal interstices of the uncovered portions of the stent. Once the stent borders are freed, the PCSEMS can be removed in typical fashion. Additional strategies to avoid stent migration include insertion of FCSEMS, with endoclips deployed at the proximal stent border to fasten the stent to the mucosa. More recently, the Apollo OverStitch device (Apollo Endosurgery, Austin, TX) may be used to suture the proximal end of the stent in place. There are limited safety and efficacy data available at this point that report on any of these alternative methods. Cases of colonic stent placement for the successful treatment of lower GI tract leaks and fistulae are less commonly reported. The high likelihood of stent migration within the colon makes stent placement a less viable option. However, some groups have reported successful use of covered esophageal SEMS and covered biodegradable esophageal stents (not available in the United States) for the purpose of treating colorectal fistulae in small series.22,23
Clip Closure Although endoscopic stenting and diversion of the luminal stream are often helpful, stent migration can be an issue as previously described. Some leaks are not in regions that are easily bypassed with an enteral stent. Especially with small leaks, endoscopic closure may be performed by using various endoscopic clips. Multiple small-capacity through-the-scope clips (TTSCs) are at times used to sequentially close luminal disruptions. Newer OTSCs (OTSC System; Ovesco Endoscopy AG, Tubingen, Germany) obtain a much larger bite, bringing a larger region of tissue into approximation. The OTSC device is a nitinol-based metal clip that at opening is packaged on a plastic cap. The cap is designed to fit over the tip of the endoscope. The cap is affixed, and a thread is brought through the working channel of the endoscope. The thread is attached to a wheel-operated deployment device that inserts into the working channel cap on the handle of the endoscope. The assembly and deployment are similar to those used for variceal banding and endoscopic mucosal resection. The region of interest is suctioned into the cap, and the clip is then deployed, approximating the edges. Care must be taken to ensure that both edges are within the cap; clips
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improperly deployed onto the edge of a lesion may make subsequent attempts at closure more challenging. For this reason, the OTSC device also contains 2 types of grasping forceps that can be inserted through the scope (and thus through the cap) to pull both edges of the tissue into the cap before the clip is released (Video 1). For endoscopic clip–based closures, the tissue surrounding the leak or fistula must be robust enough to be held within the jaws of the clips. If the tissue is weak, friable, or necrotic, the clip may incise the mucosa without bringing the edges into approximation. An endoscopic examination before the attempted closure is frequently indicated to evaluate the quality of the tissue surrounding the fistula or leak. There have been multiple reports of the use of OTSCs for closure of fistulae. One series covering multiple clip applications described the use of the OTSC in 11 perforations and 8 GI fistulae. In the setting of perforations, all 11 were closed with no recurrence. In the setting of fistulae, primary closure was achieved in all 8; however, there was a recurrence in 5 patients.24 Another small series of 4 patients described the use of the OTSC for chronic fistulae. Again highlighting the importance of the quality of the tissue surrounding the leak, the closure was successful in 2 patients; yet in the other 2 patients with fibrotic changes or scarring at the fistula site, the closure was unsuccessful.25 In another series of 12 patients, OTSC clip closure was successful in 11 of 12 patients, with repositioning required in 1 additional patient.26 A case report of the management of a gastrocolic fistula also described successful endoscopic closure of the fistulous communication by using an OTSC.27 In a larger case series of 14 acute and chronic colorectal postsurgical leaks and fistulae, OTSC closure was successful in 86% (acute, 87% [7 of 8] and chronic, 83% [5 of 6]). Surgery was required in 1 patient, and no OTSCrelated complications were reported.28 Novel applications such as the use of endoscopic vacuum therapy, akin to the concept of a wound vacuum, with or without OTSC closures have been reviewed.29 Another retrospective series has been reported on 30 patients treated for fistulae by using the OTSC device. Of the 30 patients, 19 (63%) had a gastric fistula after laparoscopic sleeve gastrectomy, and the overall success rate was 71%.30 In a series of varying applications (including 6 fistulae and 1 anastomotic leak), the overall success rate by using the OTSC was 75%.31 Overall, the OTSC devices enable reliable closure of larger defects, and studies suggest that a substantial number of leaks and fistulae can be successfully managed with this endoscopic approach. Assuming that the mucosa is robust enough for clipbased closure, there is limited evidence that abrasion of the tissue edges before approximation may help the tissue seal together and fuse. This concept was suggested in an animal model32 and has also been described in several other reports of closures.3,33 In our practice, we perform an initial endoscopic and fluoroscopic
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evaluation. The site is identified, and the quality of the tissue surrounding the fistula is assessed. The leakage and communication are confirmed by contrast fluoroscopy or with the use of dye. Once the findings have been reviewed and the options discussed, an endoscopic closure may be considered. The tissue edges and surrounding areas are ablated with APC. A cytology brush is then used to abrade the lateral aspects. If applicable, the OTSC device can then be deployed to bring the edges into approximation. Contrast is injected, filling the lumen in the region of the leak, and the adequacy of the closure is inspected in real time. Any ongoing leak may be managed by further clipping or stenting as described above.
Endoscopic Suturing Other endoscopic approaches to the closure of GI fistulae may involve the application of endoscopic suturing systems. Endoscopic suturing is significantly more difficult from a technical aspect than the application of clipping devices. However, suturing systems may be capable of closing larger defects. Suturing requires additional training and considerable expertise on the part of the endoscopist. The same concerns described regarding the quality of the tissue surrounding the area of leak apply with endoscopic suturing. The tissue must be sufficiently healthy and strong to hold the sutures and not tear or incise when the sutures are cinched and the tissue is pulled toward apposition. In one of the largest series to date, the authors compared endoscopic suturing with endoscopic clipping for the management of gastro-gastric fistulae after Roux-en-Y gastric bypass. There were 95 total patients, and 71 received endoscopic suturing (EndoCinch; C. R. Bard, Inc, Murray Hill, NJ).33 The mean size of the fistula was significantly larger in the suturing group. The initial results were promising, with 95% of patients achieving complete primary closure; however, fistula site reopening was seen in 65%. None of the larger fistulae (initial size, >20 mm) remained closed during the follow-up period, although approximately one-third of patients (32%) with initial fistula size 10 mm achieved long-term closure. In a series with similar outcomes, an endoscopic system for tissue apposition (with antecedent mucosal ablation) was used for 4 patients with 5 gastro-gastric fistulae. The mucosal ablation was performed to produce a raw surface by using needleknife cautery, snares, and hot/cold biopsy graspers to promote fusion when the lateral aspects were brought into contact. There was excellent success in achieving primary closure (100%); however, after 3 months, only the smallest fistula (initially 10 mm) remained completely closed, and at 6 months, it also revealed a visible pinhole-sized opening.34 The data to date show good results with initial fistula closure. For long-term closure, however, the best results for gastro-gastric
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fistulae are seen with fistulae 10 mm in diameter. Overall, with gastric fistulae after bariatric surgery, durability may be limited. With other types of fistulae, there are case series of successful closure by using suturing systems. An esophagopleural fistula was successfully closed by using multiple techniques including stenting, glue, and 2 sessions of endoscopic suturing.35 In abstract form, 6 patients were described with 1 esophagomediastinal, 3 gastrocutaneous, and 2 bronchoesophageal fistulae.36 The esophagomediastinal fistula was treated with stenting (sutured in place). The 3 patients with gastrocutaneous fistulae were closed with interrupted and running sutures in 2 separate layers. One developed dehiscence at 10 days after procedure and was then closed again by using a second suturing session. The 2 patients with bronchoesophageal fistulae were closed, but dehiscence of the sutures occurred and required multiple repeat suturing sessions (3 and 4) before complete closure. Endoscopic suturing is an appealing concept for its ability to closely mimic surgical closure techniques. The currently available systems have evolved during the past decade, but further refinement is necessary to improve the technical feasibility of the procedure for most therapeutic endoscopists and to allow for greater application of use.
Tissue Sealants One of the first reports on successful fistula closure by means of an endoscopic technique used fibrin glue injected into the aberrant openings of patients with high-output enterocutaneous fistulae.1 Since then, several reports have been published on the success of using tissue sealants in this regard. Both fibrin glue and cyanoacrylate have been used with moderate success.37–39 The sites of application mostly include areas of anastomotic leakage after esophagectomy and gastrectomy or after bariatric surgical procedures (eg, esophagogastric anastomoses or gastrojejunal anastomoses, respectively). Typically, the mucosa around the opening of the fistula is de-epithelialized so that when the site is plugged or closed with a combination of clips and sealant, there is a reactive inflammatory response around the opening that promotes complete sealing. As noted, this can be accomplished by using a standard biliary cytology brush to gently abrade the edges of the fistula. Also, APC at low power settings can be used for this purpose. Application of the tissue sealant is usually performed with a double-lumen catheter inserted down the working channel of the endoscope, because both components of the sealant (eg, fibrin glue) begin to react and form a bond immediately on contact. The larger lumen of the catheter should be reserved for the more viscous component.10 As reported previously by Kumar and Thompson,10 rapid exchange/short-wire
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double-lumen endoscopic retrograde cholangiopancreatography catheters should not be used, because the sealant may leak out the sides of the catheter and damage the endoscope channel. High-output GI fistulae are less likely to successfully close with the use of tissue sealant alone.40 Combination therapy by using clips and covered stents along with glue appears to be more successful.3,37 For larger openings, Vicryl mesh plugs or soft tissue grafting material such as Surgisis (Cook Inc, West Lafayette, IN) may be used to fill in the gaps before glue injection or in combination with clip application and stent placement.41 Long-term success with complete fistula closure is welldocumented in small series that use these combined methods.42
Discussion GI leaks and fistulae may be acute and lifethreatening or may become chronic and clinically debilitating. Fistulae may occur spontaneously between organs because of inflammatory conditions or malignancy, or they may be the result of GI surgeries such as organ resection or bariatric procedures. Anastomotic leaks may complicate 5%–30% of esophageal anastomoses9,43,44 and 5%–15% of rectal anastomoses.45–47 Some leaks may potentially be managed conservatively. Such initial trials often involve diet restriction, no feeding above the leak, parenteral nutrition, antibiotics, and percutaneous catheter–based approaches to provide drainage of fluid collections. Addressing nutrition is often a key step in enabling the patient to heal the fistulous communication, either with or without the application of endoscopic closure techniques. Although the sections in this review have been separated by technique, quite commonly a combination of different techniques is applied together. For example, an esophagogastric fistula may be best managed with tissue abrasion, fibrin glue injection, and endoscopic clip closure, followed by esophageal stent placement over the fistula site to divert the luminal stream. Regardless of the specific techniques used, there are several overriding principles that apply to all patients undergoing endoscopic closure of leaks and fistulae. First, almost all patients will require multispecialty involvement. Care should be delivered by a team that will typically involve advanced endoscopy, surgery, interventional radiology, and nutrition. Second, definition and delineation of the site of the leak are critical. This is often aided by contrast radiology studies. Third, if a fluid collection or cavity exists, insertion of percutaneous drainage catheter before endoscopic closure should be strongly considered. The injection of contrast and the insufflation of gas into a non-drained space can create major complications and infections. Fourth, careful evaluation of the quality of the tissue surrounding the leak/fistula is important.
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The quality of the tissue surrounding the defect is often critical in determining which closure technique is best applied. Fifth, the main goal of endoscopic therapy is the interruption of the flow of luminal contents across the defect. Ongoing flow tends to maintain the patency of the defect, and a method of interrupting the flow (eg, clip closure device, stent placement, tissue adhesive, etc) is a key step in promoting closure. Sixth, the adequacy of the closure should be studied ideally at the time of the procedure, after the closure, and in followup to confirm continued integrity. Use contrast radiography to assess for ongoing leak and also expect that a sound closure should be evidenced by decreasing volumes and negligible output via the percutaneous drain over time. In conclusion, advanced endoscopic methods are enabling less invasive and more physiological approaches for the management of GI leaks and fistulae. A multidisciplinary approach is a critical component in developing the correct treatment pathway; some leaks and fistulae are not amenable to endoscopic closure. For those that are, endoscopic closures represent significant progress in the minimally invasive management of GI leaks and fistulae.
Supplementary Material Note: To access the supplementary material accompanying this article, visit the online version of Clinical Gastroenterology and Hepatology at www.cghjournal.org, and at http://dx.doi.org/10.1016/j.cgh.2015.02.010.
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Reprint requests Address requests for reprints to: Field F. Willingham, MD, MPH, Emory University Hospital, 1364 Clifton Road NE, Atlanta, Georgia 30322. e-mail: field. Q2 [email protected]; fax: (404) 778-2925. Conflicts of interest The authors disclose no conflicts.
Q3
Funding Supported in part by a development grant from the Department of Medicine at Q4 Emory University School of Medicine.
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