Joshua S Winder, MD, Afif N Kulaylat, MD, Jane Schubart, MS, MBA, PhD, Hassan M Hal, MD, Eric M Pauli, MD. Penn State Milton S. Hershey Medical Center
Introduction: Advanced endoscopic techniques are rapidly evolving and providing clinicians with novel ways to address issues that were historically treated with surgical interventions. The Ovesco over the scope clipping (OTSC™) system (Ovesco Endoscopy AG, Tübingen, Germany) has recently been shown to be effective at endoscopic closure of gastrointestinal(GI) defects including acute perforations, leaks, and fistulae. We hypothesize that by following classic principles of fistula management that we can achieve a higher rate of long term success than has been previously described.
Methods: A retrospective review of a prospectively maintained institutional database was performed at one institution (Penn State Milton S. Hershey Medical Center) from 2012 to 2014. All patients referred for management of gastrointestinal leaks or fistulae who underwent attempted closure with the OTSC™ system were included. All preoperative, intraoperative, and postoperative imaging were reviewed with a staff radiologist to characterize the leak/fistula and identify any long-term failures. The primary endpoint was long-term closure defined by absence of radiographic or clinical evidence of leak or fistula. Patients were stratified according to success or failure of the Ovesco clip intervention in the closure of the defect and were compared with Fishers’ Exact and Mann-Whitney U tests, as appropriate.
Results: 17 patients with a total of 20 defects (14 fistulae and leaks) were included in the study. Most patients were female (65%) with a median patient age of 47 (range 29-85), and had undergone a bariatric procedure (60%). Notable comorbidities included obesity (55%), smoking history (65%), and diabetes (25%). The majority of fistulae were solitary (55%), involved the upper gastrointestinal tract (80%), had been present for >30 days (70%), were between -3 cm in length (55%), with a median defect diameter of 7. mm (range 3-23). Prior therapeutic interventions to address the defects had been attempted in 60% of patients. A total of 26 OTSCs were applied. In cases foreign bodies(suture material) were removed at the site of defect. In cases a distal obstruction or stricture was identified requiring balloon dilatation or stenting. There were no adverse outcomes related to OTSC placement or misfiring. Overall success rate was 75% (100% for the leak group and 64% for the fistula group) at a median follow-up of . months. Differences in characteristics between successful and failed treatment of the defect did not meet statistical significance due to small sample size.
Conclusions: We have shown that the OTSC system can be safely and effectively used in patients presenting with GI leaks and fistulae. Our success rate of 64% for fistulae and 100% for leaks is somewhat higher than the rates currently being reported by other groups. Although our sample size was not sufficient to conclude that any one factor has lead to these successes, it is in line with previously published data suggesting that GI fistulae have a lower long term success rate than leaks. Larger sample sizes, longer follow-up, and further research is required to further characterize the determinants of long-term success and risk factors for failure.