Clinical Application and Outcomes of Over the Scope Clip Device: Initial US Experience in Humans

Background. OTSCs are now available in the US for various indications. Methods. Retrospective review of OTSCs used from January 2011 to April 2012. Results. Twenty-four patients underwent placement of 28 OTSCs. Indications included postsurgical fistula, perforations, anastomotic leak, prophylactic closure after EMR, postpolypectomy bleeding, tracheoesophageal fistula, and jejunostomy site leak. Instruments used to grasp the tissue were dedicated (bidirectional forceps or tripronged device) and nondedicated devices (rat/alligator forceps or suction). Success was higher with nondedicated devices (12.5% versus 86.5%, ). Overall, OTSC was effective in 15/27 procedures. Defect closure was complete in 12/21. Mean followup was 2.9 months (1–8？m). Mean defect size was 10？mm (5–25？mm). A trend towards higher success was noted in defects <10？mm compared to defects >10？mm (90% versus 60%; ). No difference was noted in closure of fresh (<72？hrs) versus chronic defects (>1 month) (75% versus 67%). There were no complications. Conclusion. The OTSC provides a safe alternative to manage fistula, perforation, and bleeding. No significant difference was seen for closure of early fistula or perforations as compared to chronic fistula. Rat-tooth forceps or suction was superior to the dedicated devices. 1. Background Traditionally, surgical therapy has been the mainstay for closure of perorations and fistula in the gastrointestinal (GI) tract. Recently through the scope, clips have also been used for closure of similar defects and also as therapy for bleeding lesion in the GI tract [1]. However, these clips are limited by width of opening between the jaws and also a lower closure force leading to difficulty in tissue apposition. Multiple clips may therefore need to be placed to close larger defects and for bleeding lesions [2]. Recently an over the scope closure (OTSC—Ovesco Endoscopy, Tuebingen, Germany) device has been made available in the United States for various indications including defect closure and hemostasis. This is a nitinol based clip that is fitted over the scope with a cap. On deployment, it is capable of capturing significantly larger amounts of tissue with more force exerted for tissue apposition. We report here our data regarding the experience with the use of this OTSC device. 2. Technique and OTSC Device The OTSC is a clip made of shape-memory nitinol alloy. The advantage of nitinol is that the open clip returns to its initial closed shape when it is released from the applicator, causing closure of the two jaws of the clip. It is loaded onto the scope