Prevention of biliary stent occlusion by ursodeoxycholic acid plus norfloxacin - A multicenter randomized trial

We report a prospective randomized multicenter trial that tested the effica cy of combining ursodeoxycholic acid and norfloxacin in the prevention of p olyethylene stent clogging in patients with obstructive jaundice due to an unresectable malignancy at the level of the common bile duct. After inserti on of a 10-Fr straight polyethylene stent, patients were allocated to recei ve oral treatment with ursodeoxycholic acid and norfloxacin, or conservativ e treatment. The primary outcome measure was stent blockage within six mont hs. Thirty-three patients (group I) received ursodeoxycholic acid and norfl oxacin, and 29 received conservative treatment (group II). At six months, c umulative stent patency rate did not differ significantly between group I ( 47 +/- 11%, mean +/- SE, median 149 days) and group II patients (24 +/- 10% , mean +/- SE, median 100 days, P = 0.23, log-rank test). Four stents were clogged by ursodeoxycholic acid. Survival did not differ between the two gr oups. Combined therapy with ursodeoxycholic acid and norfloxacin failed to improve stent patency. Moreover, ursodeoxycholic acid can cause stent obstr uction.