A Prospective, Randomized, Controlled Trial of Metal Stents for Malignant Obstruction of the Common Bile Duct

Abstract

Endoscopic insertion of biliary stents is the preferred method of palliation for inoperable malignant biliary obstruction; however, migration and clogging are frequent problems with conventional endoprostheses. We sought to determine if expandable metal stents offer improved palliation compared to conventional stents. Sixty-two patients with common bile duct lesions were randomized to receive polyethylene or metal stents. Stents were placed endoscopically or by the combined percutaneousendoscopic route. Early results (< 1 month) were similar in both groups. Long-term follow-up (n = 28 polyethylene, median: 5 months; n = 27 metal, median: 5 months) showed a higher stent failure rate in the polyethylene (n = 12; 43 %) compared to the metal group (n= 6; 22 %). The incidence of cholangitis was significantly higher (p < 0.05) in the polyethylene (n = 10; 36 %) compared to the metal group (n = 4; 15 %). Life-table analysis showed a significantly reduced incidence of sten failure (p = 0.0035) in the metal stent compared to the polyethylene group. The total duration of hospital stay for treatment of stent related problems was significantly higher in the polyethylene (11.8 ± 3 days) compared to the metal group (4 ± 1.9 days; p = 0.02). The costs for retreatment because of stent failure were significantly higher in the plastic (DM 5900 ± 1516) compared to the metal group (DM 2070 ± 977). As a result, the overall costs (treatment of stent related complications & stents) were higher in the polyethylene group (DM 6000 ± 1500). Expandable metal stents offer cost effective palliation of distal malignant biliary obstruction with fewer complications, reduced re-intervention rates and decreased hospital stays for stent-related problems.