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). 1. Introduction Benign biliary strictures are common and challenging clinical problems. The two leading etiologies are chronic pancreatitis (CP) and postoperative complications, either related to bile duct injury at the time of cholecystectomy or anastomotic narrowing after orthotopic liver transplantation (OLT). The reported incidence of benign biliary strictures among CP patients ranges from 3 to 46% [1]. In post-OLT setting, biliary tract complications can occur in up to 30% of patients [2]. Furthermore, biliary strictures can occur in 0.5 to 0.9% of patients undergoing laparoscopic cholecystectomy [3, 4]. Other less frequent causes are primary sclerosing cholangitis, papillary stenosis, autoimmune pancreatitis, and bile duct stones [5]. Benign biliary strictures can present with a variety of clinical scenarios that range from mild elevation of liver enzymes to recurrent episodes of cholangitis to secondary biliary cirrhosis and end stage liver disease [6]. In order to prevent these serious complications, proper and early effective treatment of these strictures is essential. Traditionally, benign biliary strictures had been
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