한빛사논문
Jang, Dong Kee MD, PhDa; Park, Young Suk MD, PhDb; Yoo, Moon-Won MDc; Hwang, Sun-Hwi MD, PhDd; Ryu, Seong-Yeob MD, PhDe; Kwon, Oh Kyoung MD, PhDf; Hur, Hoon MD, PhDg; Man Yoon, Hong MD, PhDh; Eom, Bang Wool MDh; Ahn, Hye Seong MD, PhDi; Son, Taeil MDj; Song, Kyo Young MD, PhDk; Lee, Han Hong MD, PhDk; Choi, Min-Gew MD, PhDl; An, Ji Yeong MD, PhDl; Lee, Sang-Il MD, PhDm; Lee, Sang Hyub MD, PhDn,*; Park, Do Joong MD, PhDo,*
aDepartment of Internal Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea
bDepartment of Surgery, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea
cDepartment of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
dDepartment of Surgery and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Republic of Korea
eDepartment of Surgery, Chosun University Hospital, Kwangju, Republic of Korea
fDepartment of Surgery, Kyoungpook National University Chilgok Hospital, Daegu, Republic of Korea
gDepartment of Surgery, Ajou University Hospital, Suwon, Republic of Korea
hCenter for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea
iDepartment of Surgery, Boramae Medical Center, Seoul, Republic of Korea
jDepartment of Surgery, Yonsei University Severance Hospital, Seoul, Republic of Korea
kDepartment of Surgery, Catholic University Seoul St. Mary’s Hospital, Seoul, Republic of Korea
lDepartment of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
mDepartment of Surgery, Chungnam National University Hospital, Daejeon, Republic of Korea
nDepartment of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea
oDepartment of Surgery, Seoul National University Bundang Hospital, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea
Dong Kee Jang and Young Suk Park contributed equally.
*Corresponding authors: Do Joong Park, Sang Hyub Lee
Abstract
Background: Few studies have been conducted on the prevention of bile reflux in gastric cancer patients who have undergone gastrectomy. The aim of this study was to evaluate the efficacy and safety of ursodeoxycholic acid (UDCA) in preventing bile reflux after gastrectomy in patients with gastric cancer.
Methods: This study was a secondary analysis of the PEGASUS-D trial, a randomized, double-blind, placebo-controlled clinical trial. Adults with a diagnosis of gastric cancer who underwent gastrectomy were enrolled. Eligible participants were randomly assigned to receive 300 mg of UDCA, 600 mg of UDCA, or placebo at a ratio of 1:1:1. UDCA and placebo were administered daily for 52 weeks. The primary outcomes included bile reflux symptoms at each time point, percentage of participants with bile reflux, and the grade of gastritis.
Results: Among 521 participants who underwent randomization, 151, 164, and 150 participants were analyzed from the 300 mg UDCA, 600 mg UDCA, and placebo groups, respectively. The difference in symptoms between the three groups 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.
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.
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