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Malignant Biliary Obstruction: Treatment with ePTFE-FEP– covered Endoprostheses—Initial Technical and Clinical Experiences in a Multicenter Trial¹

¹ From the Department of Angiography and Interventional Radiology, University of Vienna Medical School, Waehringerguertel 18-20, A-1090 Vienna, Austria (M.S., A.S., M.A.F., M.C., J.L.); Department of Radiology, University of Rome "La Sapienza," Italy (P.R., M.B.); and Interventional Radiology, Medical University of South Carolina, Charleston (R.U.). Received October 25, 2001; revision requested December 3; revision received February 15, 2002; accepted March 14. Address correspondence to M.S. (e-mail: maria.schoder@univie.ac.at).

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.

© RSNA, 2002

Index terms: Bile duct radiography, 76.1225, 76.1226 • Bile ducts, interventional procedures, 76.1267, 76.1269 • Bile ducts, neoplasms, 76.32 • Bile ducts, stenosis or obstruction, 76.32 • Bile ducts, stents and prostheses, 76.1267, 76.1269

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