A novel antireflux metal stent for the palliation of biliary malignancies: a pilot feasibility study (with video).

Antireflux stents that prevent duodenal biliary reflux may improve biliary drainage and prolong stent patency. However, the use of antireflux metal stents (ARMSs) in the human biliary system has not been reported.To evaluate the safety and efficacy of ARMSs for the palliation of unresectable distal biliary malignancies.A retrospective case series in a tertiary referral center.From August 2007 to April 2009, a total of 23 patients with unresectable nonhilar malignant biliary obstruction.Endoscopic placement of an ARMS.Technical success and early complications with follow-up of stent patency and patient survival.Placement of an ARMS was successful on the first attempt in all patients. There were no procedure-related complications. Follow-up was obtained in 22 cases. Serum bilirubin level returned to normal within 1 month of stenting in 20 patients. Six stent malfunctions occurred as a result of tumor ingrowth (1 patient), tumor overgrowth (2 patients), and stent migration (3 patients). The remaining patients were free of biliary symptoms until death or final follow-up. The median duration of stent patency of ARMSs was 14 months, with cumulative patency rates at 3, 6, and 12 months of 95%, 74%, and 56%, respectively. The median survival of the patients was 7.9 months (range, 1-14 months).Small number of patients in single endoscopy center.Endoscopic insertion of an ARMS is technically feasible, safe, and effective in patients with distal malignant biliary obstruction. The impact of ARMSs in prolonging stent patency and life expectancy deserves further randomized evaluation.