Ursodeoxycholic acid for the prevention of recurrent complications after acute gallstone pancreatitis, a double-blind, multicenter, randomized controlled trial.


Multicenter, randomized, double-blind (ursodeoxycholic acid vs. placebo), parallel-group, controlled, superiority clinical trial.




Active, recruiting patients. New centers are welcome.


Acute biliary pancreatitis is a frequent disease, associated with a considerable health cost and with a tendency to recurrence if early cholecystectomy is not performed. The reality in Spanish centers is that the waiting list for cholecystectomy delays it for months, exposing the patient to a high probability (20% to 25%) of complications derived from biliary lithiasis. These complications would be avoidable, so in addition to the morbimortality of these complications, if they occur, they also represent a strong frustration and dissatisfaction of the patient with the health system. Ursodeoxycholic acid has been shown to dissolve cholesterol gallstones, but its ability to reduce the incidence of biliary complications in this context has not been rigorously studied.

The present study is a multicenter, double-blind, randomized, placebo-controlled clinical trial. Patients suffering a first episode of acute biliary pancreatitis will be randomized to receive either ursodeoxycholic acid or placebo. Its main objective is to investigate whether ursodeoxycholic acid reduces the incidence of complications associated with gallstones (acute pancreatitis, biliary colic, cholecystitis, cholangitis or choledocholithiasis).

Ongoing studies