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AN EXTENSTION STUDY OF THE PEGASUS-D TRIAL TO EVALUATE THE LONG-TERM EFFICACY OF URSODEOXYCHOLIC ACID FOR THE PREVENTION OF GALLSTONE FORMATION AFTER GASTRECTOMY IN PATIENTS WITH GASTRIC CANCER
Date
May 21, 2024
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Background/Aim: The objective of this study is to assess the long-term efficacy of ursodeoxycholic acid (UDCA) in preventing gallstone formation after gastrectomy in patients with gastric cancer.
Methods: This is an extension study of the PEGASUS-D trial (a multicenter, randomized, double-blind, placebo-controlled phase 3 trial) where participants were randomly assigned to receive either 300 mg of UDCA, 600 mg of UDCA, or placebo at a ratio of 1:1:1, and drugs were administered for 52 weeks. Subjects included in the full analysis set in the PEGASUS-D trial, who consented to participation or were exempt from informed consent, were included. If more than 5 years had passed since gastrectomy at enrollment, data were collected retrospectively until that time; if less than 5 years had passed, data were collected prospectively up to 5 years. The primary endpoint was the proportion of subjects with gallstone formation after gastrectomy. Secondary endpoints included the incidence of symptomatic gallstones, acute cholecystitis, cholangitis, gallstone pancreatitis, hepatic abscess, and cholecystectomy.
Results: A total of 431 participants (UDCA 600mg, 150; UDCA 300mg, 141; placebo, 140) were enrolled. Up to 80 months after gastrectomy, the proportion of gallstone formation was 18/150 (12.0%, P=0.064) in the 600 mg group, 13/141 (9.2%, P=0.0007) in the 300 mg group, and 13/140 (24.3%) in the placebo group, with a significantly lower rate in the UDCA group (Fig. 1). However, secondary endpoints, including symptomatic gallstones evaluated until the same period, did not show significant differences among the three groups. Participants who took UDCA at least once during the entire period (33/303, 10.9%) had a significantly lower rate of gallstone formation at 80 months compared to those who never took UDCA (25/128, 19.5%) (P=0.0163).
Conclusion: This study demonstrated that taking UDCA for one year after gastrectomy prevents gallstone formation for a long period of time.
Methods: This is an extension study of the PEGASUS-D trial (a multicenter, randomized, double-blind, placebo-controlled phase 3 trial) where participants were randomly assigned to receive either 300 mg of UDCA, 600 mg of UDCA, or placebo at a ratio of 1:1:1, and drugs were administered for 52 weeks. Subjects included in the full analysis set in the PEGASUS-D trial, who consented to participation or were exempt from informed consent, were included. If more than 5 years had passed since gastrectomy at enrollment, data were collected retrospectively until that time; if less than 5 years had passed, data were collected prospectively up to 5 years. The primary endpoint was the proportion of subjects with gallstone formation after gastrectomy. Secondary endpoints included the incidence of symptomatic gallstones, acute cholecystitis, cholangitis, gallstone pancreatitis, hepatic abscess, and cholecystectomy.
Results: A total of 431 participants (UDCA 600mg, 150; UDCA 300mg, 141; placebo, 140) were enrolled. Up to 80 months after gastrectomy, the proportion of gallstone formation was 18/150 (12.0%, P=0.064) in the 600 mg group, 13/141 (9.2%, P=0.0007) in the 300 mg group, and 13/140 (24.3%) in the placebo group, with a significantly lower rate in the UDCA group (Fig. 1). However, secondary endpoints, including symptomatic gallstones evaluated until the same period, did not show significant differences among the three groups. Participants who took UDCA at least once during the entire period (33/303, 10.9%) had a significantly lower rate of gallstone formation at 80 months compared to those who never took UDCA (25/128, 19.5%) (P=0.0163).
Conclusion: This study demonstrated that taking UDCA for one year after gastrectomy prevents gallstone formation for a long period of time.
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