OBJECTIVE: The purpose of this study is to investigate the efficacy and safety of a novel double stent in patients with malignant extrahepatic biliary obstruction. SUBJECTS AND METHODS: 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). RESULTS: 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. CONCLUSION: 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.
OBJECTIVE: The purpose of this study is to investigate the efficacy and safety of a novel double stent in patients with malignant extrahepatic biliary obstruction. SUBJECTS AND METHODS: 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). RESULTS: 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. CONCLUSION: 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.