bilateral versus unilateral metallic stent deployment in patients with malignant hilar biliary strictures due to biliary tract carcinoma

Abstract Background/Aim: Several single arm studies demonstrated the feasibility of using a Metallic Stent (MS) to manage Malignant Hilar Biliary Strictures (MHBS). We conducted a multi-center, prospective, randomized study to investigate the clinical significance of bilateral MS deployment in patients with MHBS caused by unresectable Biliary Tract Carcinoma (BTC). Methods: The patients with MHBS due to unresectable BTC were randomly allocated to endoscopic unilateral or bilateral stenting. The primary endpoint was the stent dysfunction rate at 6 months. Results: Between April 2011 and March 2014, 40 patients were randomly allocated to the bilateral group and 39 patients to the unilateral group. The procedure success rate was 93% (37/40) in the bilateral group and 100% (39/39) in the unilateral group (NS). The median survival time was 237 days in the bilateral group and 236 days in the unilateral group (NS). However, the median stent-functioning time was 295 days in the bilateral group and 187 days in the unilateral group (p=0.049, generalized Wilcoxon test). Conclusion: Despite including a smaller number of patients than planned, our findings suggest that bilateral MS deployment should be the first treatment for patients with MHBS due to unresectable BTC. Keywords Bilateral metallic stent deployment; Biliary tract carcinoma; Malignant hilar biliary strictures; Stent dysfunction