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©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 21, 2024; 30(3): 238-251
Published online Jan 21, 2024. doi: 10.3748/wjg.v30.i3.238
Effectiveness of antibiotic prophylaxis for acute esophageal variceal bleeding in patients with band ligation: A large observational study
Chikamasa Ichita, Sayuri Shimizu, Tadahiro Goto, Uojima Haruki, Naoya Itoh, Masao Iwagami, Akiko Sasaki
Chikamasa Ichita, Uojima Haruki, Akiko Sasaki, Gastroenterology Medicine Center, Shonan Kamakura General Hospital, Kamakura 247-8533, Kanagawa, Japan
Chikamasa Ichita, Sayuri Shimizu, Tadahiro Goto, Department of Health Data Science, Yokohama City University, Yokohama 236-0027, Kanagawa, Japan
Tadahiro Goto, TXP Research, TXP Medical Co., Ltd., Chiyoda-ku 101-0042, Tokyo, Japan
Tadahiro Goto, Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Bunkyo-ku 113-0033, Tokyo, Japan
Uojima Haruki, Department of Genome Medical Sciences Project, Research Institute, National Center for Global Health and Medicine, Ichikawa 272-8516, Chiba, Japan
Naoya Itoh, Division of Infectious Diseases, Aichi Cancer Center, Nagoya 464-8681, Aichi, Japan
Masao Iwagami, Department of Health Services Research, Institute of Medicine, University of Tsukuba, Tsukuba 305-8575, Ibaraki, Japan
Author contributions: Ichita C contributed to the planning, data gathering, literature review, writing, and editing of the manuscript; Shimizu S and Goto T are experts in epidemiological statistics and were responsible for the causal inference and analysis methods in this study; Haruki U is an expert in portal hypertension and provided appropriate advice in this field, whereas Itoh N is an expert in infectious diseases and offered appropriate guidance on antibiotics; Iwagami M is a leading expert in the use of the Tokushukai medical database and provided appropriate advice on its utilization; Sasaki A is an expert in endoscopy and provided valuable advice on endoscopic hemostasis; all the authors reviewed the various drafts of the manuscript and have approved the final version of the manuscript.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of the Future Medical Research Centre Ethical Committee (Approval No. TGE02100-02).
Informed consent statement: Owing to the observational nature of the study, where patient data were accessed from hospital medical records without taking biological samples from patients, informed patient consent was not deemed to be necessary. Instead, an opt-out method directed at patients was employed on the website of each hospital.
Conflict-of-interest statement: All other authors have nothing to disclose.
Data sharing statement: Due to privacy and ethical considerations, the data supporting the findings of this study is not publicly available. However, the study protocol and analysis code can be made available upon contacting the corresponding author. As for the participant data, ethical approval is required for access. The corresponding author can facilitate this process upon receipt of an appropriate request. After ethical approval, data sharing will be possible. The process of accessing the data will be carried out in accordance with ethical guidelines, ensuring respect for participant privacy and confidentiality.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Chikamasa Ichita, MD, Chief, Gastroenterology Medicine Center, Shonan Kamakura General Hospital, No. 1370-1 Okamoto, Kamakura 247-8533, Kanagawa, Japan. ichikamasa@yahoo.co.jp
Received: October 4, 2023
Peer-review started: October 4, 2023
First decision: December 6, 2023
Revised: December 12, 2023
Accepted: January 3, 2024
Article in press: January 3, 2024
Published online: January 21, 2024
ARTICLE HIGHLIGHTS
Research background
Esophageal variceal bleeding is a critical complication of liver cirrhosis, typically managed with endoscopic variceal ligation (EVL). While current Western guidelines advocate antibiotic prophylaxis post-EVL, the evolving landscape of cirrhosis management and the rise of multidrug-resistant bacteria necessitate a reevaluation of this practice.
Research motivation
This study was motivated by the need to reassess the effectiveness of routine antibiotic prophylaxis following EVL in the context of improved cirrhosis treatments and increasing concerns regarding antibiotic resistance. Understanding the real-world impact of prophylaxis on patient outcomes may result in a more effective and judicious use of antibiotics.
Research objectives
The primary objective was to evaluate the effectiveness of antibiotic prophylaxis in patients undergoing EVL for esophageal variceal bleeding using data from multiple Japanese medical centers. The study aimed to provide evidence that could influence future guideline recommendations and clinical practice.
Research methods
A 13-year observational study was conducted, using the Tokushukai medical database that includes data from 46 hospitals. Patients were categorized into prophylaxis and non-prophylaxis groups, with outcomes measured in terms of mortality, rebleeding, and spontaneous bacterial peritonitis. Logistic regression, inverse probability of treatment weighting, subgroup, and sensitivity analyses were conducted.
Research results
The study included 790 patients, and the primary outcomes were not significantly different between the prophylaxis and non-prophylaxis groups. These findings persisted across various subgroups and sensitivity analyses, suggesting that routine antibiotic prophylaxis post-EVL may not be beneficial.
Research conclusions
These findings challenge the current standard of prescribing antibiotics following EVL for esophageal variceal bleeding. They highlight the need for a global reassessment of this practice, considering the minimal impact on patient outcomes and the broader context of antibiotic resistance.
Research perspectives
Future research should focus on personalized approaches to antibiotic use in cirrhosis-related procedures, considering patient-specific factors and broader public health concerns. Further studies should also explore alternative strategies for managing complications in patients with liver cirrhosis.
