A newly designed over-the-scope-clip device to prevent fully covered metal stents migration: A pilot study

Abstract Background Fully covered self-expandable metal stents (FCSEMS) have increasingly been used in the endoscopic management of malignant and benign gastrointestinal diseases. The main limitation of FCSEMS is the risk of migration, occurring in at least one-third of patients. Different methods have been employed for anchorage of esophageal stent, as external fixation with endoscopic snare and internal fixation using both through-the-scope (TTS) and over-the scope (OTS) clips to fix the upper flared end of the FCSEMS to the esophageal mucosa. A new designed over-the-scope device called Stentfix OTSC® System (AG-Tuebingen– Germany), has been developed to avoid migration. It consists in a Nitinol clip preloaded on the applicator cap used to clip the flared end of FCSEMS to the gastrointestinal mucosal layer Aims To evaluate the clinical outcomes of patients treated with Stentfix device. Methods Five consecutive patients (median age: 58 years; males, 80%) were enrolled. All patients had experienced FCSEMS migration. The OTSC device was placed to prevent further stent migration. Results Technical and clinical success was achieved in all patients. In one patient with a benign rectal anastomotic stricture long-term luminal patency was achieved after stent placement. One patient died of causes unrelated to endoscopic procedures. The other patients are still being followed. Dysphagia improvement of at least 1 point was seen in these patients. Conclusions The StentfixOTSC® System appears to be a useful and safe device in the preventing FCSEMS migration in a variety of clinical scenarios.