A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct.

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 percutaneous-endoscopic 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 stent 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).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes