Malignant biliary obstruction: treatment with ePTFE-FEP- covered endoprostheses initial technical and clinical experiences in a multicenter trial

PURPOSE: To determine and present the initial technical and clinical results of using an expanded polytetrafluoroethylene-fluorinated ethylene propylene (ePTFE-FEP)-covered biliary endoprosthesis to treat malignant biliary obstruction. MATERIALS AND METHODS: This prospective nonrandomized study included 42 patients with malignant obstruction of the common bile duct, common hepatic duct, and hilar confluence. Unilateral (n = 38) or bilateral (n = 4) bile duct drainage was performed by using fully covered endoprostheses with anchoring fins. To avoid branch duct blockage, endoprostheses with drainage holes at the proximal end were available. Procedure- and device-related complications were recorded. Patient survival and stent patency rates were calculated with Kaplan-Meier survival analysis. Mean follow-up bilirubin and alkaline phosphatase levels were calculated, and differences in means were evaluated with a paired t test. RESULTS: Successful deployment, correct positioning, and patency of the device were achieved in all patients. Procedure-related complications occurred in two (5%) patients. Thirty-day mortality rate was 20% (eight of 41 patients), and median survival time was 146 days. Laboratory values decreased significantly after the procedure (P <.001). Recurrent obstructive jaundice occurred in six (15%) patients. Primary patency rates at 3, 6, and 12 months were 90%, 76%, and 76%, respectively. Calculation of the composite end point of death or obstruction revealed a median patency duration of 138 days. No endoprosthesis migration was observed. Branch duct obstruction was observed in four (10%) patients. Postmortem examination of one stent revealed a widely patent endoprosthesis with intact covering. CONCLUSION: Initial results of percutaneous treatment of malignant biliary obstructions with fully covered ePTFE-FEP endoprostheses suggest that they are safe and potentially clinically effective.