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Preventive effect of prophylactic intravenous antibiotics against cholangitis in biliary atresia: a randomized controlled trial

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Abstract

Objective

Biliary atresia (BA) is a neonatal liver disease and requires Kasai portoenterostomy. Many patients develop postoperative cholangitis, resulting in a poor prognosis. The preventive strategy of antibiotics is empirical and lacks a standard regimen. We aimed to analyze the effect of different durations of prophylactic intravenous antibiotics against post-Kasai cholangitis.

Study design

A single-center, open-labeled, randomized clinical trial was performed from June 2016 to August 2017. One hundred and eighty BA patients were recruited and randomized into a short-term (n = 90) and a long-term (n = 90) treatment group, and prophylactic intravenous antibiotics were used for 7 versus 14 days, respectively. The primary outcome was the overall cholangitis incidence within 6-months post-Kasai portoenterostomy. The secondary outcomes included cholangitis incidence within 1 and 3 months post-Kasai portoenterostomy, the onset and average episodes of cholangitis, jaundice clearance rate, native liver survival rate, and adverse events within 6-months post-Kasai portoenterostomy.

Results

The cholangitis incidence within 6-months post-Kasai in the short-term group was similar to the long-term group (62% vs. 70%, p = 0.27) with intention-to-treat and pre-protocol analysis. There was no significant difference in jaundice clearance rate or native liver survival rate between the two groups. However, the percentage of early onset (61% vs. 38%, p = 0.02) and average episodes (2.4 ± 0.2 vs. 1.8 ± 0.1 episodes, p = 0.01) of cholangitis were lower in the long-term group.

Conclusion

Long-term intravenous antibiotics can be replaced by the short-term regimen in the general protection against post-Kasai cholangitis.

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Data availability

This trial was registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/), title “Therapeutic effect of prophylactic intravenous antibiotics after Kasai procedure in biliary atresia patients”, registration number: ChiCTR-IPR-16008609. This article is licensed under a Creative Commons Attribution 4.0 International License. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. Application should be submitted to szheng@shmu.edu.cn.

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Acknowledgements

We would like to thank all the doctors and nurses in the Department of Pediatric Surgery of Children’s Hospital of Fudan University for the cooperation during the trial. We would like to thank professor Weili Yan from the Department of Clinical Epidemiology, Children’s Hospital of Fudan University for the help in study design and statistical analyses.

Funding

This study was supported by the Shanghai Hospital Development Center (Grant No SHDC12014106), Shanghai Key Disciplines (Grant No.2017ZZ02022), Shanghai Outstanding Youth Medical Talents (Grant No EK00000622), National Natural Science Foundation of China (Grant No 81873545).

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Author notes

  1. Gong Chen and Jia Liu are co-first author.

Authors and Affiliations

  1. Department of Pediatric Surgery, Shanghai Key Laboratory of Birth Defect, Children’s Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, China

    Gong Chen, Jia Liu, YanLei Huang, Ying Wu, XueXin Lu, Rui Dong, Zhen Shen, Song Sun, Jingying Jiang & Shan Zheng

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Contributions

Conceptualization and design of the study: Shan Zheng, Jia Liu, YanLei Huang, Gong Chen. Data collection coordination and supervision: SZ, GC Data collection instruments design: XL, RD, ZS. Data collection: JL, YH, GC, SS, YW. Data analyses: JL, XL, RD, SS, YW, GC. Manuscript drafting: GC, JL, XL, RD, SS, YW. Manuscript review and revise: SZ, GC, JJ. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Shan Zheng.

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Conflict of interest

All the authors declare that they have no conflict of interest.

Ethical approval

This study was approved by the Ethics Board for Human Research of the Children’s Hospital of Fudan University, Shanghai, China in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and later amendments.

Consent to participate

Parents and/or legal guardians were appropriately informed and gave written consent for the participation of the participants in this study in all cases.

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All authors consent that this manuscript, if accepted, will be published in Pediatric Surgery International.

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Chen, G., Liu, J., Huang, Y. et al. Preventive effect of prophylactic intravenous antibiotics against cholangitis in biliary atresia: a randomized controlled trial. Pediatr Surg Int 37, 1089–1097 (2021). https://doi.org/10.1007/s00383-021-04916-z

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