Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Apr 27, 2023; 15(4): 712-722
Published online Apr 27, 2023. doi: 10.4240/wjgs.v15.i4.712
External use of mirabilite to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis in children: A multicenter randomized controlled trial
Jing-Qing Zeng, Tian-Ao Zhang, Kai-Hua Yang, Wen-Yu Wang, Jia-Yu Zhang, Ya-Bin Hu, Jian Xiao, Zhi-Jian Gu, Biao Gong, Zhao-Hui Deng
Jing-Qing Zeng, Tian-Ao Zhang, Kai-Hua Yang, Wen-Yu Wang, Jia-Yu Zhang, Jian Xiao, Zhao-Hui Deng, Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
Ya-Bin Hu, Department of Clinical Epidemiology and Biostatistics, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China
Zhi-Jian Gu, Biao Gong, Department of Gastroenterology, Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China
Author contributions: Zeng JQ and Zhang TA have contributed equally to this work; Deng ZH and Gong B conceived and designed the study and participated in logistical planning of the study; Yang KH, Wang WY, Zhang JY, Xiao J, and Gu ZJ acquired, analyzed, and interpreted the data; Hu YB performed the statistical analysis; Zhang TA and Zeng JQ contributed significantly to analysis and manuscript preparation; and all authors agreed to be accountable for all aspects of the work.
Supported by Shanghai Municipal Health Commission of China, No. 2018LP018.
Institutional review board statement: This study has been approved by the Institutional Ethnic Committee.
Clinical trial registration statement: The trial was registered in the Chinese Clinical Trial Registry (ChiCTR1900022642).
Informed consent statement: Written informed consent was willingly provided by each patient or their legal guardian.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: All the individual data, except participant data collected during the trial, will share. Study protocol, statistical analysis plans, analytic code, informed consent form, and clinical study report will be available. The data will be made available from the corresponding author (E-mail: dzhrj@163.com), upon reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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: Zhao-Hui Deng, PhD, Chief Physician, Department of Gastroenterology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, No. 1678 Dongfang Road, Shanghai 200127, China. dzhrj@163.com
Received: November 8, 2022
Peer-review started: November 8, 2022
First decision: November 23, 2022
Revised: December 1, 2022
Accepted: March 20, 2023
Article in press: March 20, 2023
Published online: April 27, 2023
Processing time: 166 Days and 0.7 Hours
ARTICLE HIGHLIGHTS
Research background

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common adverse event following ERCP. Currently, only non-steroidal anti-inflammatory drugs have been shown to be effective in preventing PEP in adults. Few studies have prospectively evaluated interventions to prevent PEP in children.

Research motivation

The occurrence of PEP could limit the application of ERCP in children, for which finding an ideal, effective, less invasive, and safe prevention strategy is desirable.

Research objectives

The objective of this study was to assess the efficacy and safety of external use of mirabilite to prevent PEP in children.

Research methods

We conducted a multicenter, randomized controlled clinical trial. Patients with chronic pancreatitis scheduled for ERCP were enrolled and randomly divided into the external use of mirabilite group and the blank group. The primary outcome was the incidence of PEP. The secondary outcomes included the severity of PEP, abdominal pain scores, levels of serum inflammatory markers, tumor necrosis factor (TNF)-α and interleukin (IL)-10, and intestinal barrier function markers, diamine oxidase (DAO), D-lactic acid, and endotoxin. Additionally, the side effects of topical mirabilite were investigated.

Research results

A total of 234 patients were enrolled, including 117 in the external use of mirabilite group and the other 117 in the blank group. The pre-procedure and procedure-related factors were not significantly different between the two groups. The incidence of PEP in the external use of mirabilite group was significantly lower than that in the blank group (7.7% vs 26.5%, P < 0.001). The severity of PEP decreased in mirabilite group (P = 0.023). At 24 h after the procedure, the visual analog score in the external use of mirabilite group was lower than that in the blank group (P = 0.001). Compared with those in the blank group, the TNF-α expressions were significantly lower and the IL-10 expressions were significantly higher at 24 h after the procedure in the external use of mirabilite group (P = 0.032 and P = 0.011, respectively). There were no significant differences in serum DAO, D-lactic acid, and endotoxin levels before and after ERCP between the two groups. No adverse effects of mirabilite were observed.

Research conclusions

External use of mirabilite reduced the occurrence of PEP. Moreover, it significantly alleviated post-procedural pain and reduced inflammatory response. Our results favor the external use of mirabilite to prevent PEP in children.

Research perspectives

This study illustrated that external use of mirabilite is a safe, effective, and more acceptable option for PEP prophylaxis in pediatric patients. Our findings would be informative to expand the field of prospective research on the prevention of pediatric PEP.