1180
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
Explore related products in the following collection:
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.
Tracks
Related Products
Management of Cholestatic Liver Disease
SOCIETY: AGA/AASLD
EXOSOMAL PROTEIN PROFILING FOR PREDICTING THE PROGNOSIS OF INTRADUCTAL PAPILLARY MUCINOUS NEOPLASMS
BACKGROUND AND AIMS: Intraductal papillary mucinous neoplasm (IPMN) is one of the well-known precancerous lesions. Predicting the malignant risk of IPMN is important but challenging…
FEMALES WITH AUTOIMMUNE LIVER DISEASES ARE AT INCREASED RISK OF MAJOR ADVERSE CARDIOVASCULAR OUTCOMES: A NATIONWIDE MATCHED COHORT STUDY
Cardiovascular disease (CVD) remains a leading cause of death in women. The Atherosclerotic Cardiovascular Disease 10-year risk score recommended by the American College of Cardiology does not encompass chronic inflammatory diseases, which is associated with increased CVD risk…
ASSESSING THE EFFICACY OF BLOOD CULTURE-GUIDED ANTIBIOTIC THERAPY: A PROSPECTIVE RANDOMIZED STUDY ON THE ROLE OF BILE CULTURE IN ACUTE CHOLANGITIS MANAGEMENT
BACKGROUND: The management of acute cholangitis often relies on the efficacy of selected antibiotic therapy, traditionally informed by both blood and bile culture findings. This study explores the hypothesis that antibiotic therapy guided exclusively by blood culture results would be sufficient…
