New ePTFE/FEP-covered stent in the palliative treatment of malignant biliary obstruction

To determine the technical efficacy and safety of an expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE/FEP)-covered metallic stent in the management of malignant biliary obstruction and to evaluate its clinical efficacy by estimating stent patency and patient survival rates.

Twenty-six patients with common bile duct stricture caused by malignant disease were treated by placement of 29 stents. The stent consists of an inner ePTFE/FEP lining and an outer supporting structure of nitinol wire. Multiple wire sections elevated from the external surface provide anchoring. Stents are available in two versions, with or without holes in the proximal stent lining. Holes should provide drainage of the cystic duct or biliary side branches when covered by the proximal stent end. Clinical evaluation and assessment of serum bilirubin and liver enzyme levels were done before stent placement and at 1, 3, 6, and 9 months. Average follow-up duration was 5.4 months (range, 5 d to 12.5 mo).

Placement was successful in all cases. The 30-day mortality rate was 11.5%. The survival rates were 40% and 15% at 6 and 12 months, respectively. Eighty-four percent of patients had adequate palliative drainage during their lifetime. The stent patency rates were 91%, 77%, and 77% at 3, 6, and 12 months, respectively. Four patients (16%) presented with stent occlusion and needed repeat intervention. No migration occurred. Complications other than stent occlusion occurred in five patients (19%); among these, acute cholecystitis was observed in three patients (12%).

Preliminary results suggest that placement of this ePTFE/FEP-covered stent is feasible and effective in achieving biliary drainage. The percentage of patients undergoing lifetime palliation and the midterm patency are promising. However, the incidence of acute cholecystitis is high. Treatment of a larger group of patients is mandatory to validate these long-term results.