Effectiveness of Ursodeoxycholic Acid (UDCA) in Preventing Bile Duct Gallstone Recurrence after Cholecystectomy: A Randomized, Double-Blind, Placebo-Controlled Trial (RCT)

Anotacija

Objective. Does ursodeoxycholic acid (UDCA) effectively prevent the recurrence of symptomatic bile duct stones that require intervention in patients who have undergone a cholecystectomy for symptomatic gallstone disease? Methods. Following successful cholecystectomy for symptomatic gallstone disease, 300 patients were randomized (1:1 ratio) to receive a 24-month course of either UDCA (300 mg twice daily) or a placebo. The primary outcome was symptomatic bile duct stones diagnosed by imaging (ultrasound, CT scan, or Magnetic Resonance Cholangiopancreatography (MRCP)) requiring treatment (endoscopic retrograde cholangiopancreatography with stone removal or surgery) during the 24-month follow-up. Secondary outcomes included changes in liver function tests and the incidence of adverse events. Results. During the 24-month follow-up, symptomatic bile duct stones requiring treatment were significantly less common in the UDCA group compared to the placebo group. Specifically, stones were found in 8 patients (5.3%) taking UDCA, but in 25 patients (16.7%) receiving the placebo. This difference was statistically significant, with a Hazard Ratio (HR) of 0.31, suggesting that patients in the UDCA group were about 69% less likely to develop stones. The study also found that liver function tests remained similar between both groups throughout the trial. In terms of safety, the frequency of adverse events was comparable between the two groups. The most common side effects reported were mild, temporary gastrointestinal symptoms. Conclusion. The postoperative administration of UDCA over a 24-month period represents a safe and effective prophylactic measure. It significantly reduces the recurrence of symptomatic bile duct stones requiring intervention in patients who have undergone a cholecystectomy for symptomatic gallstone disease.