Ursodeoxycholic acid after bile duct stone removal and risk factors for recurrence: a randomized trial

Background Currently, no established pharmacologic treatment exists for the prevention of recurrent common bile duct (CBD) stones. Methods Here, we present a multi-center randomized trial that compared the CBD recurrence rate after bile duct stone removal between patients given ursodeoxycholic acid (UDCA) and the untreated group. A total of 36 patients were randomly assigned to either the UDCA (n = 15) or the untreated group (n = 21). The primary end-point was the recurrence rate of CBD stones. Results The recurrence rate of CBD stones was 6.6% in the UDCA group and 18.6% in the untreated group (P = 0.171). A multivariate analysis found that not receiving UDCA was an independent risk factor for stone recurrence. The recurrence rates of CBD stones did not differ by sex, past history of cholecystectomy, or the presence of gallstones. Conclusions Our findings indicate that UDCA may be a novel treatment strategy to prevent the recurrence of CBD stones. However, further evaluation of UDCA in a larger number of subjects will be required to confirm the applicability of these results.