Effectiveness and safety of endoscopic treatment of benign biliary strictures using a new fully covered self expandable metal stent.

Abstract

Background. In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data are sparse. This study was performed to evaluate the long-term effectiveness and safety of a new fully covered SEMS for benign biliary strictures. Methods. All consecutive patients with benign biliary strictures were treated with placement of a fully covered SEMS (WallFlex) for 6 months. Short- and long-term stricture resolution, adverse events, and ease of stent removal were recorded. Results. 23 patients were enrolled. Stricture etiology was chronic pancreatitis (14), postorthotopic liver transplant (4), idiopathic (4), and biliary stones (1). All ERCPs were technically successful. All stents were successfully removed. Short-term stricture resolution was seen in 22/23 (96%) patients. Long-term success was 15/18 (83.3%). All 3 failures were patients with biliary strictures in the setting of chronic calcific pancreatitis. Conclusions. The use of the new SEMS for the treatment of benign biliary strictures led to short-term stricture resolution in the vast majority of patients. Over a long-term followup the success rate appears favorable compared to historical results achieved with multiple plastic stenting, particularly in patients with chronic pancreatitis. The study was registered with ClinicalTrials.gov (NCT01238900).