Self-expanding metallic stents (SEMS). (a) Commercially available stents. (b) Radiographic image of deployed stents
It is important to point out that stent deployment requires suitable anatomy and sometimes it can be challenging to securely place a stent through a gastrojejunostomy leak. Sleeve leaks which occur most often at the angle of His might require a “nested” SEMS deployment to prevent stent migration and to “depressurize the conduit, which can result in significant pain and discomfort for the patient.
Internal Drainage
Internal drainage has been reported as a quite effective, inexpensive, and safe means to drain an enteric leak in bariatric patients. The pigtail can be introduced through the operative channel over a guide wire with the help of a pigtail pusher.
Fibrin Glues
Good quality data about the use of fibrin sealants in the early treatment of leaks following bariatric surgery is lacking. One study examined 3 patients which underwent fibrin injections and found that 2/3 had resolution at mean time of 33 days [41]. The efficacy of fibrin glue injections appeared even lower in patients with late leaks [42]. This treatment modality will require more extensive investigation before implementation on a large scale.
Clips
Traditional hemostatic clips are usually not effective when used alone for the closure of fistulas. The larger over-the-scope clips, such as the Ovesco OTSC (Ovesco Endoscopy, Germany) or Padlock Clip (US Endoscopy, OH), on the other hand, create a full-thickness closure like a “bear trap” which is more suitable for this application. Specialized grasping forceps are also available for pulling tissue up into the cap prior to deployment. Occasionally multiple clips can be deployed next to each other to seal linear defects >2 cm. Feasibility of any endoscopic closure with over-the-scope clips needs to take into the account the narrow working space of a tubular gastroesophageal junction, the size and orientation of the defect, the surrounding tissue quality, and the difficulty in removing the clips once fired.
While OTSC have been described in a variety of intestinal leaks, the experience in bariatric patients is limited. Surace et al. have described a series of 19 patients, 11 with gastric fistulas following sleeve gastrectomy and a successful closure rate of 91% [43]. Another study by Winder et al. with a patient population composed of 55% bariatric patients demonstrated a similar pattern in success rates, with long-term closure achieved in 77.3 and 100% of fistulas and leak cases, respectively [44]. Both studies emphasize the necessity of multiple interventions and attempts to close the leaks. Deployment of a stent over these clips has been advocated in some previous studies [45] to further aid in closure.
Chronic fistulae are difficult to treat endoscopically for multiple reasons; fibrosis and inflammation which cause friability of the tissues tend to increase the technical difficulty of endoscopic closure. In cases where the tissue is fibrotic and difficult to draw into the firing cap with suction, two devices are available to help assist with this which are the OTSC Twin Grasper and the OTSC Anchor (Ovesco Endoscopy, Germany). Both devices are used to grasp the fibrotic edges of more chronic fistulae to help draw the entire opening into the cap prior to firing. Although these devices can effectively grasp tissue and may assist in fistula closure, the reported long-term failure rate exceeds 80% in chronic fistulae [44].
EndoVAC
Most reported studies from European institutions show an average closure rate approximating 90% and mortality rates of around 10% [46, 48–53]. A commercially assembled system (Endo-SPONGE, B. Braun Medical, Germany) is available in Europe, but this system is only FDA approved for treatment of colorectal leaks in the United States. Therefore, it is necessary to self-assemble the available devices in the United States for implementation of this therapy.
The E-Vac insertion is performed under general anesthesia for airway protection. A 16-Fr Silastic nasogastric tube (NGT) is passed through one of the nostrils and pulled out of the mouth through the bite block. At this point, the E-Vac is created and attached to the end of the NGT. The E-Vac is adapted from the small granulofoam package from KCI (San Antonio, Texas) negative pressure system. The size of the actual E-Vac is limited by the necessity to pass it through the esophageal lumen, so 3–4 cm width and 6–8 cm length is the maximum size that can be safely passed through the esophagus. Once the E-Vac is cut to the appropriate size, a tunnel is created through its center to the tip without exiting the sponge. The NGT is then placed into this tunnel to encompass the extent of the foam making sure that all fenestrations on the NGT are within the sponge. The tube may need to be trimmed at the tip to accommodate this. Once in place, a 2–0 permanent suture is used to fix the E-Vac to the proximal portion of the NGT. A U-stitch is used to wrap the suture around the circumference of the E-Vac. Another suture is used at the tip of the NGT, through the E-Vac, and an air knot is created. This knot is used is to grasp the E-Vac with rat tooth forceps and facilitate carrying it into place. The scope should be driven into the cavity to get the tip of the NGT and E-Vac extraluminally. The E-Vac can be pushed, from its proximal portion into the fistula cavity with the rat tooth forceps, and then should be left in place. The NGT then should be adapted to connect to the KCI negative pressure machine (San Antonio,TX), and settings should be set to 175 mmHg, high, and continuous. The sponge should be changed every 3 days. This procedure should be repeated as the fistula cavity closes and eventually seals.
Early/Intermediate Leaks
When diagnosed promptly, early and intermediate leaks have the best prognosis for the patient. Early leaks can be approached through multiple therapeutic options although there is little comparative data available in the literature. In the appropriate setting and in most contained leaks, a regimen of drainage, antimicrobials, nil per os, and nutritional support (parenteral or jejunal) result in closure within 5 weeks in 90% of patients [19, 26, 54, 55]. Despite high resolution rates, a traditional percutaneous approach comes at the cost of significant distress for the patient that needs to be placed nil per os in case of high output leaks for several weeks and places him at risk for the complications derived from parenteral nutrition and/or additional procedures to gain enteric access which might be difficult to obtain in a bariatric patient. On the other end, surgical exploration and repair with drainage show similar efficacy in early but not intermediate/late leaks. Primary surgical repair performed after 2–3 days or in the face of significant peritoneal contamination is unlikely to succeed [18]. In both early and intermediate leaks, endoscopic therapies offer important alternatives to classical therapy. Further management should take into account the diameter of the opening, the time since inception, and size and degree of contamination of the cavity. Generally speaking all the previously described techniques used alone or in combination provide successful means to achieve resolution of the leaks.
Late Leaks and Fistulas
When presenting or diagnosed late, leaks will be associated with significant and persistent soiling. Similarly, leaks that have failed previous management may have inflammation or granulation complicating treatment. In series with late leaks, nonoperative strategies had success rates between 40% and 80% [27, 29]. Failure requiring alternative treatments was higher in patients with late leaks and fistulas compared with those with early leaks. However, in most of these series, failures of nonoperative and operative therapies responded to stenting. Fully covered esophageal stents can improve healing by minimizing soiling and inflammation of the wound. Several small case series involving late leaks diagnosed after postoperative day 8 reported 100% success rates when stents were left in situ for 2–4 months, demonstrating complete healing on contrast esophagogram when removed [28, 34, 56]. Other series of stenting on the other end were less successful and demonstrated 50%–80% healing rates of delayed fistulas with stents alone [32, 57].
Other treatment options are available for late leaks not amenable to stenting. Fibrin sealants, fistula plugs, and endoscopic suturing are only a few of the other modalities attempted for closure of fistulas. Though most series are small, results are promising. Injection of fibrin glue, biologic and degradable, into the leak orifice was uniformly successful in 11 selected patients coming from 4 series with no adverse events [23, 25]. Similarly, fistula plugs can provide a scaffolding for healing a chronic fistula and were particularly useful for fistulas 1.5 cm or wider, resulting in healing in ~80% of patients in small series [58, 59]. Endoscopic plication of the mucosa adjacent to the fistula over the orifice has also been described [60, 61]. Increasingly complex fistulas may require several technologies simultaneously. A few series examined outcomes of multimodality therapy for complex fistulas after bariatric procedures. Employing a combination of transluminal debridement, OTSC, fibrin sealants, and stenting was shown to achieve 100% success in a series of 27 patients with complex late fistulas larger than 10 mm at a mean of 86 days and a median of 4.4 endoscopies per patient [45].
Fistulization between the gastric pouch and gastric remnant can occur after gastric bypass and demands a separate discussion. This was more common due to staple line failure when the pouch was created with a nondividing stapler, which has fallen out of favor. Other causes include incomplete division of the fundus during gastric bypass, pouch staple line leak with abscess formation and decompression into the remnant, and marginal ulcer that erodes into the gastric remnant [62]. These fistulas can present with symptoms similar to marginal ulcer, or with weight regain and lack of satiety. Upper gastrointestinal series and endoscopy are the initial diagnostic modalities of choice. For small fistulas of a less than 5 mm in size, endoscopic closure with over-the-scope clip is a useful technique to achieve closure [20]. Surgical treatment including total gastrectomy with esophagojejunostomy, conversion of SG to RYGB, should be reserved only to patients with chronic leaks that have failed initial endoscopic management [17, 63, 64].
Conclusion
Historically, complications of bariatric surgery required operative therapy. This was morbid and sometimes even deadly for patients. Over the last decade, the role of endoscopy has emerged as an effective and less invasive approach to manage many of these complications.
There are several endoscopic approaches that have been found to achieve success in these difficult scenarios. Over-the-scope type of clips appears to be particularly suited for small early leaks <1 cm. Internal drainage with a pigtail stent seems to achieve comparable resolution rates and is useful for more chronic leaks with contained extramural fluid collections. E-Vac application is useful in leaks which have failed other therapeutic means and where high degree of contamination is present. Fully covered SEMS are successful in early as well as late leaks and fistulas, as a stand-alone treatment or as adjunct modality when the anatomy of the patient favors their placement.