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


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.


CONCLUSIONS
Initial results of percutaneous treatment of malignant biliary obstructions with fully covered ePTFE-FEP endoprostheses suggest that they are safe and potentially clinically effective.
D000008:Abdominal Neoplasms / Q000150:complications*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017734:Bile Ducts, Extrahepatic; D002758:Cholangiography; D001651:Cholestasis, Extrahepatic / Q000209:etiology / Q000628:therapy*; D020099:Coated Materials, Biocompatible; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D011138:Polytetrafluoroethylene / Q000031:analogs & derivatives*; D011446:Prospective Studies; D015641:Radiography, Interventional; D015607:Stents; D005465:Fluorocarbon Polymers
D020099:Coated Materials, Biocompatible; D011138:Polytetrafluoroethylene; C096305:fluorinated ethylene propylene; D005465:Fluorocarbon Polymers