Hydrophilic hydromer-coated polyurethane stents versus uncoated stents in malignant biliary obstruction: a randomized trial

Background: Hydromer-coated polyurethane stents (HCPS) have a low coefficient of friction that may reduce sludge formation and potentially increase stent longevity. Methods: Eighty-three patients (39 men, mean age 69.3 years) with malignant mid or distal bile duct strictures were prospectively randomized to receive either 10F HCPS (n = 40) or standard polyethylene stents (n = 43). Results: Fifteen patients (18.1%) underwent surgery after stent insertion. Six patients were lost to follow-up (7.2%), whereas 34 died of the underlying disease without evidence of stent occlusion (15 HCPS group and 19 polyethylene group). Median survival was 75 days (range 15 to 372 days) and 108 days (range 25 to 325 days) in the HCPS and polyethylene stent groups, respectively (p = not significant). Stent occlusion was observed in 25 patients (42%), 16 with HCPS stents and 9 with polyethylene stents, with a median patency of 103 days (range 40 to 280 days) and 68 days (range 32 to 175 days), respectively (p = not significant). Conclusions: HCPS do not appear to provide significant clinical advantages in terms of stent longevity over standard plastic prostheses. (Gastrointest Endosc 2000;51:8-11.)