Upper GI
Do Joong Park, MD, PhD, FACS
Professor
Seoul National University Hospital
Seoul, Republic of Korea
Do Joong Park, MD, PhD, FACS
Professor
Seoul National University Hospital
Seoul, Republic of Korea
Do Joong Park, MD, PhD, FACS
Professor
Seoul National University Hospital
Seoul, Republic of Korea
Dong Kee Jang, MD, PhD
Professor
Dongguk University Ilsan Hospital, United States
Young Suk Park, MD
Professor
Seoul National University Bundang Hospital, United States
Moon-Won Yoo, MD, PhD
Professor
Asan Medical Center, United States
Sun-Hwi Hwang, MD, PhD
Professor
Pusan National University Yangsan Hospital, United States
Seong-Yeob Ryu, MD, PhD
Professor
Chosun University Hospital, United States
Oh Kyoung Kwon, MD, PhD
Professor
Kyoungpook National University Chilgok Hospital, United States
Hoon Hur, MD, PhD
Professor
Ajou University Hospital, United States
Hong Man Yoon, MD, PhD
Doctor
National Cancer Center, United States
Bang Wool Eom, MD, PhD
Professor
National Cancer Center, United States
Hye Seong Ahn, MD, PhD
Professor
Boramae Medical Center, United States
Taeil Son, MD, PhD
Professor
Yonsei University Severance Hospital, United States
Kyo Young Song, MD, PhD
Professor
Catholic University Seoul St. Mary’s Hospital, United States
Han Hong Lee, MD, PhD
Professor
Catholic University Seoul St. Mary’s Hospital, United States
Min-Gew Choi, MD, PhD
Professor
Samsung Medical Center, United States
Ji Yeong An, MD, PhD
Professor
Samsung Medical Center, United States
Sang-Il Lee, MD, PhD
Professor
Chungnam National University Hospital, United States
Sang Hyub Lee, MD, PhD
Professor
Seoul National University Hospital, United States
Bile reflux gastritis and bile acid-induced carcinogenesis may arise as major problems in patients who underwent gastrectomy for gastric cancer. This study aimed to evaluate the symptoms and endoscopic findings of bile reflux examined in the PEGASUS-D study and assess the efficacy of ursodeoxycholic acid (UDCA) for treating bile reflux after gastrectomy.
Methods:
The PEGASUS-D trial is a multicenter, randomized, double-blind, placebo-controlled trial conducted in South Korea that enrolled patients who had undergone gastrectomy for gastric cancer. Eligible participants were randomly assigned to receive 300 mg UDCA, 600 mg UDCA, or placebo at a ratio of 1:1:1. Bile reflux symptoms (upper abdominal pain, heartburn, and nausea) were assessed at each visit using a self-administered questionnaire. Upper gastrointestinal endoscopy was performed at three and 12 months post-operation (or at termination of participation) to assess bile reflux and gastritis. The primary outcomes included bile reflux symptoms at each time point, percentage of participants with bile reflux, and the grade of gastritis. In the present secondary analysis, only patients who underwent gastrectomy with Billroth I, Billroth II (B-II), or Roux-en-Y reconstructions were included.
Results:
A total of 521 participants were randomly selected from 625 eligible patients across 12 participating institutions. In this secondary analysis, 120, 133, and 122 participants were analyzed from the 300 mg UDCA, 600 mg UDCA, and placebo groups, respectively. Although the scores for each symptom and the overall symptom score decreased over time, the difference between the UDCA groups and control group was not significant. Bile reflux was less evident in the UDCA group than in the placebo group; however, this difference was significant only in the 300-mg group at 12 months post-operation (odds ratio, 0.44; P = 0.0076). A significant reduction in gastritis was also observed in the 300-mg group at 12 months post-operation (odds ratio, 0.50; P = 0.0368) compared to the placebo group. UDCA 600 mg was superior to UDCA 300 mg in preventing bile reflux, particularly in patients with B-II anastomosis assessed at three months post-operation.
Conclusions:
This study showed that UDCA administration significantly reduced bile reflux and gastritis by approximately 50% at the 12 months-postoperative follow-up in patients who underwent gastrectomy for gastric cancer.