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  11. Efficacy And Safety Of Ursodeoxycholic Acid For The Prevention Of Gallstone Formation After Gastrectomy In Patients With Gastric Cancer: The Pegasus-d Randomized Clinical Trial

Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial

Sang Hyub Lee1, Dong Kee Jang2, Moon-Won Yoo3

  • 1Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.

JAMA Surgery
|June 26, 2020

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View abstract on PubMed

Summary
This summary is machine-generated.

Ursodeoxycholic acid (UDCA) significantly reduced gallstone formation in gastric cancer patients post-gastrectomy. This study highlights UDCA as a preventive measure against gallstones after this surgery.

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Area of Science:

  • Gastroenterology
  • Oncology
  • Clinical Pharmacology

Background:

  • Gallstone incidence increases post-gastrectomy.
  • Limited research exists on preventing gallstones after gastrectomy.

Purpose of the Study:

  • To evaluate ursodeoxycholic acid (UDCA) efficacy and safety in preventing gallstones after gastrectomy for gastric cancer.

Main Methods:

  • A multicenter, randomized, double-blind, placebo-controlled trial (PEGASUS-D study).
  • 521 patients received 300 mg UDCA, 600 mg UDCA, or placebo daily for 52 weeks.
  • Gallstone formation assessed via ultrasonography over 12 months.

Main Results:

  • Gallstone incidence was 5.3% (300 mg UDCA), 4.3% (600 mg UDCA), and 16.7% (placebo).
  • UDCA significantly reduced gallstone formation compared to placebo (OR 0.27 and 0.20, respectively).
  • No significant adverse drug reactions were observed.

Conclusions:

  • UDCA administration for 12 months effectively prevents gallstone formation post-gastrectomy in gastric cancer patients.
  • UDCA is a safe and effective option for preventing gallstones in this patient population.