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Ursodeoxycholic Acid Prevents Gallstone Formation After Gastric Cancer Surgery
Patients who received ursodeoxycholic acid (UDCA) following gastrectomy for gastric cancer developed significantly fewer gallstones than those given placebo, according to results of the PEGASUS-D trial (JAMA Surg. 2020 Jun 17. Epub ahead of print).
“The incidence of gallstones has been reported to increase after gastrectomy,” Sang Hyub Lee, MD, PhD, Seoul National University Hospital, Seoul, Republic of Korea, and co-investigators wrote.
Because few studies have been conducted in this area, Dr Lee at al sought to evaluate the efficacy of UDCA in preventing gallstone formation after gastrectomy in patients with gastric cancer.
A total of 521 patients were enrolled in this trial across 12 centers in Korea and randomized in a 1:1:1 ratio to receive UDCA 300 mg (n = 175), UDCA 600 mg (n = 178), or placebo (n = 168) daily for 52 weeks.
The primary end point was the proportion of patients developing gallstones within 12 months of gastrectomy. Abdominal ultrasonography was performed every 3 months for 12 months to observe and assess gallstone formation.
In the 300-mg arm, the proportion of patients developing gallstones within 12 months after gastrectomy was 5.3% versus 4.3% in the 600-mg arm and 16.7% in the placebo arm.
The odds of developing gallstones were reduced in the 300-mg and 600-mg arms compared with the placebo arm.
No significant adverse drug reactions were detected amongst the 3 arms; the most common were nausea (n = 4) and skin rash (n = 3).
Dr Lee and colleagues determined that the administration of UDCA for 12 months after gastrectomy for gastric cancer significantly reduced the incidence of gallstones.
“These findings suggest that UDCA administration prevents gallstone formation after gastrectomy in patients with gastric cancer,” they concluded.—Kaitlyn Manasterski
