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.