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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
Processing time: 106 Days and 3 Hours
BACKGROUND
Esophageal variceal bleeding is a severe complication associated with liver cirrhosis and typically necessitates endoscopic hemostasis. The current standard treatment is endoscopic variceal ligation (EVL), and Western guidelines recommend antibiotic prophylaxis following hemostasis. However, given the improvements in prognosis for variceal bleeding due to advancements in the management of bleeding and treatments of liver cirrhosis and the global concerns regarding the emergence of multidrug-resistant bacteria, there is a need to reassess the use of routine antibiotic prophylaxis after hemostasis.
AIM
To evaluate the effectiveness of antibiotic prophylaxis in patients treated for EVL.
METHODS
We conducted a 13-year observational study using the Tokushukai medical database across 46 hospitals. Patients were divided into the prophylaxis group (received antibiotics on admission or the next day) and the non-prophylaxis group (did not receive antibiotics within one day of admission). The primary outcome was composed of 6-wk mortality, 4-wk rebleeding, and 4-wk spontaneous bacterial peritonitis (SBP). The secondary outcomes were each individual result and in-hospital mortality. A logistic regression with inverse probability of treatment weighting was used. A subgroup analysis was conducted based on the Child-Pugh classification to determine its influence on the primary outcome measures, while sensitivity analyses for antibiotic type and duration were also performed.
RESULTS
Among 980 patients, 790 were included (prophylaxis: 232, non-prophylaxis: 558). Most patients were males under the age of 65 years with a median Child-Pugh score of 8. The composite primary outcomes occurred in 11.2% of patients in the prophylaxis group and 9.5% in the non-prophylaxis group. No significant differences in outcomes were observed between the groups (adjusted odds ratio, 1.11; 95% confidence interval, 0.61-1.99; P = 0.74). Individual outcomes such as 6-wk mortality, 4-wk rebleeding, 4-wk onset of SBP, and in-hospital mortality were not significantly different between the groups. The primary outcome did not differ between the Child-Pugh subgroups. Similar results were observed in the sensitivity analyses.
CONCLUSION
No significant benefit to antibiotic prophylaxis for esophageal variceal bleeding treated with EVL was detected in this study. Global reassessment of routine antibiotic prophylaxis is imperative.
Core Tip: Esophageal variceal bleeding, a serious condition linked to liver cirrhosis, often requires endoscopic treatment. While western guidelines suggest using antibiotics after endoscopic treatment, data from multiple Japanese medical centers indicates that these prophylactic antibiotics are not associated with 6-wk mortality. Based on advances in cirrhosis treatment and the appropriate use of antibiotics, the necessity of routine prophylaxis must be reassessed.
