Double-Stent System with Long Duodenal Extension for Palliative Treatment of Malignant Extrahepatic Biliary Obstructions: A Prospective Study

OBJECTIVE: To investigate the technical safety and clinical efficacy of a double-stent system with long duodenal extension in patients with malignant extrahepatic biliary obstruction. MATERIALS AND METHODS: This prospective study enrolled 48 consecutive patients (31 men, 17 women; mean age, 61 years; age range, 31–77 years) with malignant extrahepatic biliary obstructions from May 2013 to December 2015. All patients were treated with a double-stent system with long duodenal covered extension (16 cm or 21 cm). RESULTS: The stents were successfully placed in all 48 patients. There were five (10.4%) procedure-related complications. Minor complications were self-limiting hemobilia (n = 2). Major complications included acute pancreatitis (n = 1) and acute cholecystitis (n = 2). Successful internal drainage was achieved in 42 (87.5%) patients. Median patient survival and stent patency times were 92 days (95% confidence interval [CI], 61–123 days) and 83 days (95% CI, 46–120 days), respectively. Ten (23.8%) of the 42 patients presented with stent occlusion due to food impaction with biliary sludge, and required repeat intervention. Stent occlusion was more frequent in metastatic gastric cancer patients with pervious gastrectomy, but did not reach statistical significance (p = 0.069). CONCLUSION: Percutaneous placement of a double-stent system with long duodenal extension is feasible and safe. However, this stent system does not completely prevent stent occlusion caused by food reflux.