In a Korean trial reported in JAMA Surgery, Lee et al found that treatment with ursodeoxycholic acid was successful in preventing gallstone formation in patients who had undergone gastrectomy for gastric cancer.
Study Details
In the multicenter double-blind trial, 465 evaluable patients undergoing total, distal, or proximal gastrectomy were randomly assigned 1:1:1 between May 2015 and January 2017 to receive oral ursodeoxycholic acid at 300 mg (n = 151), ursodeoxycholic acid at 600 mg (n =164), or placebo (n = 150) daily for 52 weeks starting within 2 weeks of gastrectomy.
All patients underwent screening abdominal ultrasonography to identify preexisting gallstones if ultrasonography had not been performed within 6 weeks prior to the study. Gallstone formation was assessed via abdominal ultrasonography every 3 months for 12 months. The primary endpoint was the proportion of patients who developed gallstones within 12 months postgastrectomy.
Gallstone Formation Rates
Within 12 months after gastrectomy, gallstones had developed in 8 patients (5.3%) in the 300-mg group, 7 patients (4.3%) in the 600-mg group, and 25 patients (16.7%) in the placebo group. The odds ratios vs placebo were 0.27 (P = .002) for the 300-mg group and 0.20 (P < .001) for the 600-mg group.
All detected gallstones were gallbladder stones, with no bile duct or intrahepatic duct stones being detected during the study period. Gallstone complications occurred in four patients during the study period—all in the placebo group—and consisted of one case of acute cholangitis and three cases of cholecystitis.
KEY POINTS
- Ursodeoxycholic acid significantly reduced gallstone formation vs placebo following gastrectomy.
- Treatment was not associated with a significantly higher rate of adverse events.
Adverse Events
Adverse events occurred in 4.7% of patients in the 300-mg group, 1.7% of the 600-mg group, and 1.8% of the placebo group, with no statistically significant differences among groups being observed. Gastrointestinal adverse events were observed in 1.7%, 1.1%, and 1.2% of patients, and skin or subcutaneous adverse events were observed in 2.3%, 0.6%, and 0.6%, respectively.
The investigators concluded, “Administration of ursodeoxycholic acid for 12 months significantly reduced the incidence of gallstones after gastrectomy for gastric cancer. These findings suggest that ursodeoxycholic acid administration prevents gallstone formation after gastrectomy in patients with gastric cancer.”
Do Joong Park, MD, PhD, of Seoul National University College of Medicine, is the corresponding author for the JAMA Surgery article.
Disclosure: The study was supported by Daewoong Pharmaceutical Co Ltd. For full disclosures of the study authors, visit jamanetwork.com.
