• Tsuyoshi Mukai, Ichiro Yasuda, Hiroyuki Isayama, Takuji Iwashita, Takao Itoi, Hiroshi Kawakami, Hirofumi Kogure, and Yousuke Nakai.
• Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
• Dig Endosc. 2016 Sep 1; 28 (6): 671-9.

Background And AimIn patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events.MethodsThis prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement.ResultsTechnical and functional success rates of the procedures were 100%. Six-month non-RBO rate was 50%, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at <30 days) developed in six patients (16%; cholecystitis, one; pancreatitis, one; hyperamylasemia, one; pancreatic ductitis, one; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients.ConclusionOur novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events.© 2016 Japan Gastroenterological Endoscopy Society.

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