Placement of a Newly Designed Y-Configured Bilateral Self-Expanding Metallic Stent for Hilar Biliary Obstruction: A Pilot Study

Whether unilateral or bilateral drainage should be performed for malignant hilar biliary obstruction remains a matter of debate. Although a Y-stent with a central wide-open mesh facilitates bilateral stent placement, it has its own limitations. This study aims to evaluate the feasibility and efficacy of a newly designed Y-configured bilateral self-expanding metallic stent (SEMS) for the treatment of hilar biliary obstruction. In this retrospective study, 14 consecutive patients with unresectable malignant hilar biliary obstruction (Bismuth type II or higher), who underwent placement of a newly designed Y-configured bilateral SEMS for hilar biliary obstruction from April 2013 to March 2015, were included into this study. Data on technical success, clinical success, stent patency, complications and patient survival were collected. Technical and clinical success was 100 and 92.9 %, respectively. Mean serum bilirubin level was significantly decreased 1 month after stent placement (P < 0.01). Furthermore, two patients (14.3 %) had early complications (one patient had severe hemobilia and one patient had cholangitis), and two patients (14.3 %) had late complications (one patient had cholangitis and one patient had cholecystitis). During the mean follow-up period of 298 days (range 89-465 days), six patients (42.9 %) developed stent occlusion caused by tumor ingrowth or overgrowth (n = 5) and sludge (n = 1). Median stent patency and overall survival times were 281 days (95 % CI 175.9-386.1 days) and 381 days (95 % CI 291.4-470.6 days), respectively. The use of the newly designed Y-configured bilateral SEMS is feasible and effective for hilar biliary obstruction using port docking deployment.