UDCA, the Main Ingredient in Ursa, Reduces Gallstone Risk by Up to 67% After Gastric Cancer Surgery
"Study Expected to Support Revision of Korean Gastric Cancer Association Guidelines"
Daewoong Pharmaceutical’s liver function improvement product, ursodeoxycholic acid (UDCA), has been shown to significantly reduce the risk of gallstone formation in gastric cancer surgery patients, while maintaining its preventive effect for an extended period even after discontinuation.
Daewoong Pharmaceutical announced on March 26, 2026, that the results of this study, conducted on gastric cancer patients who underwent gastrectomy, have been published in the international journal 'International Journal of Surgery.'
The proportion of patients forming gallstones over the follow-up period after taking ursodeoxycholic acid. Daewoong Pharmaceutical
View original imageThis study is a multicenter Phase 4 extension study that followed up with patients who participated in a previous Phase 3 clinical trial. A total of 431 patients were included.
The results showed that the UDCA group had a significantly lower risk of developing gallstones compared to the placebo group. At the 80-month follow-up, the incidence of gallstones was 26.21% in the placebo group, 10.00% in the 300mg UDCA group, and 12.83% in the 600mg UDCA group. This represents a reduction of approximately 67% and 57%, respectively, compared to the placebo group.
Notably, the preventive effect against gallstones was maintained for up to 80 months, even after discontinuing UDCA following 12 months of administration. This is the first study to conduct long-term follow-up on the preventive effect over time in post-gastrectomy patients.
After gastric cancer surgery, the risk of gallstone formation increases due to impaired gallbladder contractility and rapid weight loss. In fact, the incidence of gallstones in gastrectomy patients has been reported to be as high as 32%.
The problem is that treating gallstones can place a significant burden on patients. Cholecystectomy or endoscopic gallstone removal may be necessary, but the procedures become more complicated in patients whose anatomical structures have been altered by surgery.
Currently, the clinical guidelines from the Korean Gastric Cancer Association recommend one year of UDCA administration after gastrectomy to prevent gallstones, but evidence for long-term efficacy has been limited. This study provides data confirming the long-term preventive effect, which may be used to strengthen future clinical guidelines.
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UDCA is an orally administered drug that has been used for the treatment of liver diseases and prevention of gallstones. Its safety has been established through long-term use.
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