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Randomized Trial of Prophylactic Antibiotics for Endoscopic Retrograde Cholangiopancreatography in Patients With Biliary Obstruction
- Title
- Randomized Trial of Prophylactic Antibiotics for Endoscopic Retrograde Cholangiopancreatography in Patients With Biliary Obstruction
- Authors
- Leem; Galam; Sung; Min Je; Park; Ji Hoon; Kim; So Jeong; Jo; Jung Hyun; Lee; Hee Seung; Ku; Nam Su; Jeong Youp; Bang; Seungmin; Seung Woo; Song; Si Young; Chung; Moon Jae
- Ewha Authors
- 김소정
- SCOPUS Author ID
- 김소정
- Issue Date
- 2024
- Journal Title
- American Journal of Gastroenterology
- ISSN
- 0002-9270
- Citation
- American Journal of Gastroenterology vol. 119, no. 1, pp. 183 - 190
- Keywords
- endoscopic retrograde cholangiopancreatography (ERCP); post-ERCP bacteremia; post-ERCP cholangitis; post-ERCP complication; prophylactic antibiotics
- Publisher
- Wolters Kluwer Health
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- Abstract
- INTRODUCTION: The incidence of postendoscopic retrograde cholangiopancreatography (ERCP) infections is reported to be up to 18% in patients with biliary obstruction. Antibiotic prophylaxis may reduce the risk of infectious complications after ERCP; however, the clinical value of prophylactic antibiotics in ERCP remains controversial. METHODS: We conducted a double-blind, placebo-controlled, randomized trial to investigate whether the use of prophylactic antibiotics would reduce infectious complications after ERCP in patients with biliary obstruction. We randomly assigned patients in a 1:1 ratio to receive either a single dose of 1 g intravenous cefoxitin or normal saline as a placebo 30 minutes before undergoing ERCP. The primary outcome was the incidence of infectious complications after ERCP. RESULTS: We enrolled 378 patients, and 189 patients were assigned to each group. The risk of infectious complications after ERCP was 2.8% (5 of 176 patients) in the antibiotic prophylaxis group and 9.8% (17 of 173 patients) in the placebo group (risk ratio, 0.29; 95% confidence interval [CI], 0.11–0.74, P 5 0.0073). The incidence rates of bacteremia were 2.3% (4 of 176 patients) and 6.4% (11 of 173 patients), respectively (risk ratio, 0.36; 95% CI, 0.12–1.04; P 5 0.0599). The incidence rate of cholangitis was 1.7% (3 of 176 patients) in the antibiotic prophylaxis group and 6.4% (11 of 173 patients) in the placebo group (risk ratio, 0.27; 95% CI, 0.08–0.87; P 5 0.0267). DISCUSSION: Antibiotic prophylaxis before ERCP in patients with biliary obstruction resulted in a significantly lower risk of infectious complications, especially cholangitis, than placebo (ClinicalTrials.gov trial number NCT02958059). Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.
- DOI
- 10.14309/ajg.0000000000002495
- Appears in Collections:
- 의료원 > 의료원 > Journal papers
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