Fully-covered, self-expandable metal stents (CSEMS) in malignant distal biliary strictures: mid-term evaluation.

Background and Aims:  Limited data exist regarding fully-covered, self-expandable metal stents (CSEMS) with anchoring fins for the management of malignant distal biliary strictures. The aim of this study is to evaluate their safety and patency. Methods:  Over a period of 2 years, 70 patients (45 males, 66 ± 13 years) underwent endoscopic retrograde cholangiopancreatography (ERCP) with placement of a 10-mm (67 patients) or 8-mm diameter (3 patients) CSEMS for the palliation of distal malignant biliary obstruction (pancreatic [53] or other [17]). Data were collected prospectively for survival and stent patency; complications were evaluated retrospectively. Results:  After CSEMS placement, 17 patients proceeded to surgery, and 53 patients were deemed unresectable. Mean survival for non-surgical candidates was 180 days (range: 15–1091), and 170 days (range: 9–589) for patients who underwent surgical management. CSEMS were left in place and remained patent for a mean of 163 days (range: 15–1091) in non-surgical candidates, and a mean of 55 days (range: 5–126) in surgical candidates. Complications during placement included wire perforations (4) and proximal deployment requiring repositioning (4), one of which was complicated by a bile leak. Post-procedure complications were observed in 24 cases (34%) and included post-ERCP pancreatitis (8, with 2 of them severe), post-procedure pain (5, with 3 requiring admission), cholecystitis (3), stent occlusion (3), cholangitis (2), proximal migration (1), post-sphincterotomy bleeding (1), and sepsis leading to death (1). Conclusion:  CSEMS appear to provide acceptable short-term patency rates; however, their limited long-term patency and high complication rate might limit their widespread use. Further long-term prospective data are required to confirm this observation.