CASE STUDY

Use of sleeve-customized self-expandable metal stents for the treatment of staple-line leakage after laparoscopic sleeve gastrectomy Sigal Fishman, MD,1,* Mati Shnell, MD,1,* Nathan Gluck, MD, PhD,1 Shmuel Meirsdorf, MD,2 Subhi Abu-Abeid, MD,3 Erwin Santo, MD1 Tel Aviv, Israel

Bariatric procedures have emerged as a leading therapeutic approach in morbidly obese patients. Laparoscopic sleeve gastrectomy (LSG) was originally introduced as a bridge procedure before Roux-en-Y gastric bypass (RYGB) but has subsequently become a definitive procedure after demonstrating similar efficacy to that of RYGB for inducing weight loss.1 Moreover, LSG has demonstrated a good safety profile and is less technically demanding than RYGB.2,3 However, LSG is prone to some adverse events because of the long staple line and elevated intragastric pressure.4 These include staple-line leakage, bleeding, and sleeve stricture.4 The prevalence of staple-line leaks has been as high as 20% in some reports, but a more traditional estimate is 1% to 9%.5,6 The onset of leaks is defined as acute, early, late, or chronic depending on the time interval since surgery: up to 1 week, 1 to 6 weeks, 6 to 12 weeks, and more than 12 weeks, respectively.6 Immediate treatment usually includes surgical or percutaneous drainage, antibiotics, and nutritional support.7-9 After primary control of the leakage, further specific therapeutic approaches have been described: surgical

Abbreviations: LSG, laparoscopic sleeve gastrectomy; RYGB, Roux-en-Y gastric bypass; SEMS, self-expandable metal stent; S-SEMS, sleeve-customized self-expandable metallic stent. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. *Drs Fishman and Shnell contributed equally to this article. Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2014.11.012 Received July 8, 2014. Accepted November 5, 2014. Current affiliations: Obesity Service, Department of Gastroenterology and Liver Diseases (1), Department of Imaging (2), and Bariatric Unit, Department of Surgery (3), Tel Aviv Sourasky Medical Center, affiliated with Tel Aviv University, Tel Aviv, Israel. Reprint requests: Dr. Sigal Fishman, MD, Department of Gastroenterology and Liver Diseases, Tel Aviv Sourasky Medical Center, Tel Aviv, 64239 Israel. E-mail: [email protected].

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repair, over-the-scope clip system, fibrin glue, and covered or partially covered self-expandable metal stents (SEMSs).10-13 These stents can reduce intragastric pressure and leakage and thus expedite healing.7,14 Sleevecustomized SEMSs (S-SEMSs) are specifically designed for sleeve leakage because they are longer than the standard available esophageal stent. These longer stents have the potential to better reduce intrasleeve pressure and may have lower migration rates. Endoscopic placement of SEMSs is increasingly used; however, this practice is currently based on small case series that showed promising results. In this study we report our recent experience in the treatment of this dreaded adverse event with S-SEMSs.

METHODS We reviewed the medical records of consecutive patients diagnosed with staple-line leakage and referred to our department between June 2012 and December 2013 for treatment with S-SEMSs. The patients were managed by a multidisciplinary team that included bariatric surgeons, gastroenterologists from the bariatric endoscopy service, invasive radiologists, and nutritionists. Endoscopic evaluation of the leak location and of the presence of sleeve stricture was performed. An S-SEMS was then placed with the patient under conscious sedation and with fluoroscopic guidance (Fig. 1). The proximal third of the stent was located above the gastroesophageal junction. Hanaro stents (MI-Tech, Seoul, Korea) with a length of 18 to 24 cm and a diameter of 18 to 22 mm were used in 5 patients and the Niti-S megastents (Teawoong, Seoul, Korea) with a length of 18 or 23 cm and a diameter of 22 to 24 mm were used in 21 patients. These stents have the CE mark. In some of the patients a stricture was diagnosed in the middle of the sleeve. In those patients the longer 23cm stent was chosen and the distal tip was inserted to the first part of the duodenum. This way the whole sleeve is covered and dilated by the stent. As we explain in the discussion we believe this achieves better pressure reduction by dilating the stricture. We used a stiff guidewire, the .38-inch Amplatz Super Stiff Volume 81, No. 5 : 2015 GASTROINTESTINAL ENDOSCOPY 1291

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Figure 1. A representative case for staple-line leak treatment by S-SEMSs. A, Endoscopic view after deployment of S-SEMSs with the distal tip extending to the duodenal bulb. B, CT scan before stent insertion. Note air and extravasation of contrast material into the collection (white arrow) adjacent to the staple line (black arrow). C, CT scan after stent insertion; the leak is controlled. Contrast material is visible in the sleeve with no extravasation to the collection (white arrow). Black arrow denotes the staple line. D, Fluoroscopy demonstrating the stent that controls the leak.

(Boston Scientific, Marlborough, Mass, USA), which enabled us to deploy the long stents distally. Confirmatory fluoroscopy or radiograph was performed 1 day after the procedure, after which patients gradually resumed a soft oral diet. Our target length of treatment was between a minimum of 2 weeks and a maximum of 6 weeks. The exact length of treatment was individualized by the drainage output, the nature of the fluid, and the patient’s tolerance to the stent. We considered the treatment as technically successful if stents remained in place for at least 2 weeks because we estimated this period as the minimum duration for stents to be potentially therapeutic. The primary endpoint was clinical resolution, defined as weaning from total parenteral nutrition, resuming oral diet, removal of intra-abdominal draining tubes, and avoidance of further surgical intervention. Secondary endpoints were fistula orifice closure and adverse outcomes, including stent migration, severe bleeding, ulceration, and intolerance.

TABLE 1. Patients’ demographic data distribution according to leak timing Acute

Early

Late

Chronic

Number of patients

1

17

5

3

Mean age, y

25

41.3

45

52

Body mass index

40

39.8

41.2

36.3

Sex (male %)

0

23.5

25

0

Twenty-six consecutive patients with staple-line leak confirmed by CT scan were treated with S-SEMSs. Patients’ characteristics stratified by the timing of the leak are

depicted in Table 1. Eighty percent of patients (21/26) were women with an average age of 42 and body mass index of 41 before surgery. The average time between surgery and clinical presentation was 40  31 days. Surgical and nutritional treatment is summarized in Table 2. One patient (4%) presented with an acute leak, 17 (65%) with early leaks, 5 (19%) with late leaks, and 3 (12%) with chronic leaks. In 1 case the stent was used as a second-line treatment after failure of an over-the-scope clip system treatment. The presence of a mid-sleeve stricture and intervention details are summarized in Table 3 and stratified according to outcome. Proximal leaks, below the gastroesophageal

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RESULTS

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Customized S-SEMS for the treatment of staple-line leakage after LSG

TABLE 2. Supportive treatment specifications

TABLE 4. Summary of adverse events in reported patients

Number (%) Number (%)

Treatment

Severe bleeding

1 (3.8)

Early removal

Severe intolerance

4 (15.4)

Early removal

Discomfort

26 (100)

High-dose PPI, Gaviscon

Migration

7 (26.9)

Repositioning

Drainage procedure Overall

23 (88.5)

Surgical

11 (42.3)

Percutaneous

9 (34.6)

Both

3 (11.6)

Nutritional support

PPI, Proton pump inhibitor.

Overall

19 (73.1)

TPN

16 (61.6)

Jejunostomy

1 (3.8)

Both

2 (7.7)

TPN, Total parenteral nutrition.

TABLE 3. Success rate stratified by stent specifications, placement, and presence of mid-sleeve stricture

Number of patients Duration, days Distal extension to duodenum Mid-sleeve stricture

Success

Failure

17 (65.4)

9 (34.6)

34.9

15.4

8 (47)

6 (66.7)

6 (35.3)

5 (55.6)

Values in parentheses are percents.

junction, were demonstrated in 96% of patients (25/26). A single patient presented with a leak distal to the incisura. A mid-sleeve stricture was noted in 11 of 26 patients (42%). In 14 of 26 patients (54%), including all patients with mid-sleeve stricture, the distal tip of the stent was located distal to the pylorus. The stent was removed after an average of 28.2  18.4 days, with a median of 26 days. In 21 of 26 patients (80.8%) the stent remained in place for over 2 weeks, defined as technical success. Overall, 17 patients achieved the primary endpoints with clinical resolution, representing 65% of all patients (17/26) and 81% of those with technical success (17/21). Interestingly, a complete fistula orifice closure was observed at the time of the stent removal in only 8 of 17 clinically successful cases (47%) (Table 3). In the subgroup of patients with mid-sleeve stricture, the overall clinical resolution rate was 55% (6/11). In those with technical success, analysis yielded a clinical success rate of 86% (6/7). Nine patients (35%) were defined as treatment failure: 7 were treated conservatively, whereas 2 required www.giejournal.org

conversion to RYGB. Five of these patients (19%) were technical failures with premature stent removal: 4 had severe reflux and retrosternal pain, and 1 patient had major bleeding from a duodenal ulcer 9 days after insertion. The bleeding was successfully controlled by endoscopic methods. Three patients (12%) who failed to show leakage control with the first stent underwent a sequential second stent insertion. In 2 patients the leak resolved. Seven patients (27%) required endoscopic repositioning of the stent because of migration, diagnosed by an upper GI series. Minor adverse events were universal, including upper GI discomfort, retrosternal pain, heartburn, and local mucosal ulcerations. These adverse events were treated successfully with an oral proton pump inhibitor, Gaviscon (Reckitt Benckiser, Slough, Berkshire, UK), and analgesics (Table 4).

DISCUSSION Staple-line leakage is a dreaded adverse event of LSG. Current data regarding the efficacy and safety of therapeutic approaches for this adverse event are limited. Previous series on the use of SEMSs reported a success rate of 33% to 100%.6,7,13,14 Herein we report our experience with S-SEMSs for sleeve leaks. Our overall clinical success rate was 65%. The main limitation was intolerance, which dictated premature stent removal. In those patients who had technically successful treatment, the clinical success rate increased to 81%. This relatively high success rate may result from the superior potency of pressure reduction and lower migration rates associated with these longer stents. Sleeve stricture was noted in 11 of 26 patients (42%), supporting the notion that stricture is an important risk factor for leakage. In all of these cases, the distal tip was positioned beyond the pylorus to achieve maximal reduction of intragastric pressure. In this subgroup of patients, overall clinical success rates were 55%, increasing to 86% in patients with technically successful treatment. Volume 81, No. 5 : 2015 GASTROINTESTINAL ENDOSCOPY 1293

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REFERENCES

Our primary goal with stent insertion has been intragastric pressure reduction and leakage control. Of note, in 53% of patients with clinical success, an open fistula orifice was detected at the time of stent removal. This may imply that complete sealing of the internal fistula orifice is not necessarily mandatory to achieve leakage control and adequate organization of the collection around the leakage point. In contrast, previous reports have emphasized the importance of actively sealing the fistula orifice by various means (ie, clip, fibrin glue) after initial control of the leak.9,12 In 5 patients the stent was removed less than 2 weeks after insertion, and these patients were defined as technical failures. Three of these 5 patients (60%) achieved the same primary outcome under conservative treatment. The question of whether diversion and leakage control with S-SEMSs improves outcome and shortens hospitalization should be addressed in larger prospective controlled trials. The safety profile seems adequate with only 1 major bleeding and no major migrations or bowel obstruction or perforation. However, pain and heartburn were universal, and 15% of patients (4/26) developed severe intolerance that mandated early stent removal. We strongly encourage physicians to discuss this issue with patients before stent insertion. Our study had several limitations. The main limitations were a relatively small group of patients, performance at a single tertiary referral center, and no control group in the study design. In conclusion, the use of S-SEMSs appears to be effective and reasonably safe to control leaks after LSG. However, tolerance issues and side effects may limit its usefulness. Further controlled prospective trials are needed to determine optimal treatment for this adverse event.

1. D'Hondt M, Vanneste S, Pottel H, et al. Laparoscopic sleeve gastrectomy as a single-stage procedure for the treatment of morbid obesity and the resulting quality of life, resolution of comorbidities, food tolerance, and 6-year weight loss. Surg Endosc 2011;25:2498-504. 2. Silecchia G, Boru C, Pecchia A, et al. Effectiveness of laparoscopic sleeve gastrectomy (first stage of biliopancreatic diversion with duodenal switch) on co-morbidities in super-obese high-risk patients. Obes Surg 2006;16:1138-44. 3. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med 2012;366:1567-76. 4. Yehoshua RT, Eidelman LA, Stein M, et al. Laparoscopic sleeve gastrectomydvolume and pressure assessment. Obes Surg 2008;18:1083-8. 5. Moszkowicz D, Arienzo R, Khettab I, et al. Sleeve gastrectomy severe complications: is it always a reasonable surgical option? Obes Surg 2013;23:676-86. 6. Rosenthal RJ, International Sleeve Gastrectomy Expert Panel, Diaz AA, et al. International Sleeve Gastrectomy Expert Panel consensus statement: best practice guidelines based on experience of O12,000 cases. Surg Obes Relat Dis 2012;8:8-19. 7. Vix M, Diana M, Marx L, et al. Management of staple line leaks after sleeve gastrectomy in a consecutive series of 378 patients. Surg Laparosc Endosc Percutan Tech 2015;25:89-93. 8. Casella G, Soricelli E, Rizzello M, et al. Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg 2009;19:821-6. 9. Bhayani NH, Swanstrom LL. Endoscopic therapies for leaks and fistulas after bariatric surgery. Surg Innov 2014;21:90-7. 10. El Mourad H, Himpens J, Verhofstadt J. Stent treatment for fistula after obesity surgery: results in 47 consecutive patients. Surg Endosc 2013;27:808-16. 11. Jacobsen GR, Coker AM, Acosta G, et al. Initial experience with an innovative endoscopic clipping system. Surg Technol Int 2012;22:39-43. 12. Sakran N, Goitein D, Raziel A, et al. Gastric leaks after sleeve gastrectomy: a multicenter experience with 2,834 patients. Surg Endosc 2013;27:240-5. 13. Bege T, Emungania O, Vitton V, et al. An endoscopic strategy for management of anastomotic complications from bariatric surgery: a prospective study. Gastrointest Endosc 2011;73:238-44. 14. Simon F, Siciliano I, Gillet A, et al. Gastric leak after laparoscopic sleeve gastrectomy: early covered self-expandable stent reduces healing time. Obes Surg 2013;23:687-92.

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Use of sleeve-customized self-expandable metal stents for the treatment of staple-line leakage after laparoscopic sleeve gastrectomy.

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