Endoscopic management of GI perforations with a new over-the-scope clip device (with videos).

Background: Through-the-scope endoclips have been used to manage small perforations in the GI tract, but they have limitations. A new over-the-scope clip system, OTSC (Ovesco Endoscopy, Tuebingen, Germany), may be suitable for the closure of larger GI leaks.

Objective: To evaluate the clinical outcomes of patients with GI perforations of up to 20 mm, treated with OTSC.

Design: Prospective, single-arm, pilot study.

Setting: General hospitals referral centers for endotherapy.

Patients: This study involved 10 patients (median age 58.5 years [range 27-82 years], 7 men) with GI leaks from perforations, fistulas, and anastomotic dehiscence. Two gastric, 2 duodenal, and 6 colonic leaks were treated with OTSC. The diameter of leaks ranged between 7 and 20 mm.

Interventions: OTSC devices were used to seal the GI leaks. Then Gastrografin (Bayer AG, Germany) was introduced via the endoscope and complete sealing confirmed under fluoroscopy. Patients underwent a second endoscopic examination 3 months later.

Main Outcome Measurement: Complete sealing of the leak.

Results: Complete sealing of leaks was achieved by using OTSC alone in 8 of 10 patients. For one patient, successful endoscopic management was completed by placing two additional covered stents. Only one patient required surgical repair of the leak. Endoscopic examination 3 months after treatment confirmed that leaks in 8 of 9 endoscopically treated patients were healed, and the patients did not have recurrence of the leaks or complications from the OTSC devices. One patient died from neoplastic progression before the second endoscopy could be performed.

Limitations: Uncontrolled study.

Conclusions: The OTSC system appears to be a useful device in the management of larger GI leaks in a variety of clinical scenarios.