A Novel Double Stent System for Palliative Treatment of Malignant Extrahepatic Biliary Obstructions: A Pilot Study

Abstract

The purpose of this study is to investigate the efficacy and safety of a novel double stent in patients with malignant extrahepatic biliary obstruction. This prospective pilot study enrolled 45 consecutive patients with malignant extrahepatic biliary obstructions from January 2008 to December 2009. All patients were treated with a novel double stent system (covered stent in uncovered stent). The double stents were successfully placed in all patients. Bilirubin levels decreased significantly after stent placement (p < 0.001). Median patient survival and stent patency times were 149 days (95% CI, 126-172 days) and 439 days (95% CI, 123-755 days), respectively. Cumulative stent patency rates at 3, 6, 9, and 12 months were 91%, 89%, 82%, and 82%, respectively. Five patients (11.1%) presented with stent occlusion due to tumor overgrowth (n = 3) or sludge incrustation (n = 2) and required repeat intervention. Tumor ingrowth, acute cholecystitis, pancreatitis, or stent migration was not observed in any of these patients. Preliminary results indicate that percutaneous treatment of malignant extrahepatic biliary obstructions using a novel double stent is feasible, safe, and effective in achieving internal biliary drainage.