한빛사논문
Sang Hyub Lee, MD, PhD1; Dong Kee Jang, MD2; Moon-Won Yoo, MD3; Sun-Hwi Hwang, MD, PhD4; Seong-Yeob Ryu, MD, PhD5; Oh Kyoung Kwon, MD, PhD6; Hoon Hur, MD, PhD7; Hong Man Yoon, MD, PhD8; Bang Wool Eom, MD8; Hye Seong Ahn, MD, PhD9; Taeil Son, MD10; Kyo Young Song, MD, PhD11; Han Hong Lee, MD, PhD11; Min-Gew Choi, MD, PhD12; Ji Yeong An, MD, PhD12; Sang-Il Lee, MD, PhD13; Kyung Ho Lee, MD, PhD14; Soyeon Ahn, PhD15; Young Suk Park, MD16; Do Joong Park, MD, PhD16,17,*; for the Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study (PEGASUS-D) Group
1Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea
2Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Republic of Korea
3Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
4Department of Surgery, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea
5Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, Republic of Korea
6Department of Surgery, Kyoungpook National University Chilgok Hospital, Daegu, Republic of Korea
7Department of Surgery, Ajou University Hospital, Suwon, Republic of Korea
8Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea
9Department of Surgery, Boramae Medical Center, Seoul, Republic of Korea
10Department of Surgery, Yonsei University Severance Hospital, Seoul, Republic of Korea
11Department of Surgery, Catholic University of Seoul St Mary’s Hospital, Seoul, Republic of Korea
12Department of Surgery, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
13Department of Surgery, Chungnam National University Hospital, Daejeon, Republic of Korea
14Department of Radiology, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea
15Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea
16Department of Surgery, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea
17Department of Surgery and Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea
*Corresponding author
Abstract
Importance
The incidence of gallstones has been reported to increase after gastrectomy. However, few studies have been conducted on the prevention of gallstone formation in patients who have undergone gastrectomy.
Objective
To evaluate the efficacy and safety of ursodeoxycholic acid (UDCA) in preventing gallstone formation after gastrectomy in patients with gastric cancer.
Design, Setting, and Participants
The PEGASUS-D study (Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study) was a randomized, double-blind, placebo-controlled clinical trial conducted at 12 institutions in the Republic of Korea. Adults (aged ≥19 years) with a diagnosis of gastric cancer who underwent total, distal, or proximal gastrectomy were enrolled between May 26, 2015, and January 9, 2017; follow-up ended January 8, 2018. Efficacy was evaluated by both the full analysis set, based on the intention-to-treat principle, and the per-protocol set; full analysis set findings were interpreted as the main results.
Interventions
Eligible participants were randomly assigned to receive 300 mg of UDCA, 600 mg of UDCA, or placebo at a ratio of 1:1:1. Ursodeoxycholic acid and placebo were administered daily for 52 weeks.
Main Outcomes and Measures
Gallstone formation was assessed with abdominal ultrasonography every 3 months for 12 months. Randomization and allocation to trial groups were carried out by an interactive web-response system. The primary end point was the proportion of patients developing gallstones within 12 months after gastrectomy.
Results
A total of 521 patients (175 received 300 mg of UDCA, 178 received 600 mg of UDCA, and 168 received placebo) were randomized. The full analysis set included 465 patients (311 men; median age, 56.0 years [interquartile range, 48.0-64.0 years]), with 151 patients in the 300-mg group, 164 patients in the 600-mg group, and 150 patients in the placebo group. The proportion of patients developing gallstones within 12 months after gastrectomy was 8 of 151 (5.3%) in the 300-mg group, 7 of 164 (4.3%) in the 600-mg group, and 25 of 150 (16.7%) in the placebo group. Compared with the placebo group, odds ratios for gallstone formation were 0.27 (95% CI, 0.12-0.62; P = .002) in the 300-mg group and 0.20 (95% CI, 0.08-0.50; P < .001) in the 600-mg group. No significant adverse drug reactions were detected among the enrolled patients.
Conclusions and Relevance
Administration of UDCA for 12 months significantly reduced the incidence of gallstones after gastrectomy for gastric cancer. These findings suggest that UDCA administration prevents gallstone formation after gastrectomy in patients with gastric cancer.
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