Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society
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Multicenter Study
Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies.
In 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. ⋯ Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events.