Safety and Efficacy of Percutaneous Y-configured Covered Stent Placement for Malignant Hilar Biliary Obstruction: A Prospective, Pilot Study

Purpose: To investigate the technical and clinical safety and efficacy of percutaneous Y-configured covered stent placement in patients with malignant hilar binary obstruction. Materials and Methods: This prospective, pilot study enrolled 20 consecutive patients with malignant hilar biliary obstructions from October 2009 to December 2010. All patients were treated by percutaneous transhepatic placement of partially expanded polytetrafluoroethylene (ePTFE)-covered stents in a Y configuration. Results: Bilateral Y-configured covered stent deployment was technically successful in all 20 patients. Minor procedure-related complications occurred in four (20%) patients including self-limiting hemobilia in one patient and rapidly resolving cholangitis in three patients. Successful internal drainage was achieved in 18 (90%) of 20 patients. Mean serum bilirubin level, which was 12.6 mg/dL +/- 5.1 before drainage, decreased significantly to 2.5 mg/dL +/- 4.5 1 month after stent placement (P < .001). Median patient survival and stent patency times were 218 days (95% confidence interval [CI] 112-324 days) and 375 days (95% CI 55-695 days). Seven (35%) patients presented with stent occlusion, in six owing to sludge incrustation and in one owing to tumor overgrowth, and required repeat percutaneous transhepatic biliary drainage (PTBD). Tumor ingrowth, acute cholecystitis, or stent migration was not observed in any patient. Conclusions: Preliminary results suggest that percutaneous palliative treatment of malignant hilar biliary obstruction with Y-configured covered stents is safe and clinically effective in achieving internal biliary drainage. Y-configured, ePTFE-covered stents can also prevent tumor ingrowth without functional occlusion of hepatic segmental bile ducts.