Long-term efficacy of ursodeoxycholic acid for the prevention of gallstone formation after gastrectomy in patients with gastric cancer: a randomized clinical trial.

BACKGROUND

The optimal long-term strategy for preventing post-gastrectomy gallstone formation in gastric cancer (GC) remains unclear. This study evaluated the sustained efficacy of a 12-month course of ursodeoxycholic acid (UDCA) after gastrectomy for GC.

METHODS

We conducted a randomized, double-blind, placebo-controlled clinical trial at 13 institutions in the Republic of Korea. Patients who underwent total, distal, or proximal gastrectomy for GC were randomized 1:1:1 to receive either 300 mg UDCA, 600 mg UDCA, or placebo daily for 12 months. The primary outcome was the incidence of gallstone formation at least 5 years post-gastrectomy. Secondary outcomes were biliary pain, gallstone complications, and cholecystectomy.

RESULTS

A total of 431 participants (300 mg UDCA: n = 141; 600 mg UDCA: n = 150; placebo: n = 140) were analyzed. At 80 months post-gastrectomy, gallstone formation occurred in 10.00% of the 300 mg group, 12.83% of the 600 mg group, and 26.21% of the placebo group. UDCA significantly reduced the hazard of gallstone formation compared to placebo (hazard ratio: 0.33, 95% CI 0.18-0.63, P = 0.0014 for 300 mg; 0.43, 95% CI 0.25-0.75, P = 0.0064 for 600 mg). There were no significant differences among groups in the incidence of biliary pain, gallstone complications, or cholecystectomy.

CONCLUSION

Twelve months of UDCA administration was associated with sustained reduction in gallstone formation for up to 80 months after gastrectomy in GC patients.