{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T21:24:34Z","timestamp":1777065874081,"version":"3.51.4"},"reference-count":27,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2016,6,6]],"date-time":"2016-06-06T00:00:00Z","timestamp":1465171200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Digestive Endoscopy"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:sec><jats:title>Background and Aim<\/jats:title><jats:p>In patients with unresectable malignant distal biliary obstruction, covered self\u2010expandable metallic stents (CSEMS) may remain patent longer than uncovered self\u2010expandable 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\u2010bore stent. Therefore, we developed a novel, 12\u2010mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This 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\u2010RBO rate 6 months after placement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Technical and functional success rates of the procedures were 100%. Six\u2010month non\u2010RBO 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 &lt;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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events.<\/jats:p><\/jats:sec>","DOI":"10.1111\/den.12643","type":"journal-article","created":{"date-parts":[[2016,2,29]],"date-time":"2016-02-29T14:30:58Z","timestamp":1456756258000},"page":"671-679","source":"Crossref","is-referenced-by-count":25,"title":["Pilot study of a novel, large\u2010bore, fully covered self\u2010expandable metallic stent for unresectable distal biliary malignancies"],"prefix":"10.1111","volume":"28","author":[{"given":"Tsuyoshi","family":"Mukai","sequence":"first","affiliation":[{"name":"Department of Gastroenterology Gifu Municipal Hospital  Gifu 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