Abstract
BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is crucial for managing pediatric hepatobiliary diseases but frequently results in postoperative gastrointestinal dysfunction such as delayed flatus and defecation, which can prolong recovery and increase the risk of complications. Nonpharmacological interventions such as acupoint massage and mirabilite application offer potential benefits, but evidence for their efficacy and synergy in children after ERCP is lacking. OBJECTIVE: This study aims to evaluate the individual and combined effects of acupoint massage and abdominal mirabilite application on accelerating gastrointestinal recovery in pediatric patients following ERCP. METHODS: A single-center, single-blind, randomized controlled trial will be conducted involving 72 children aged between 2 and 12 years who have undergone ERCP. Participants will be randomly allocated to 1 of the 4 groups: acupoint massage group (stimulating ST-36, ST-25, CV-12, and PC-6 for 2 minutes per point; twice daily), mirabilite group (abdominal application for 1 hour; twice daily), combination group (both interventions; at least 1 hour apart), or conventional care group. The primary outcome is the time to first postoperative flatus and defecation. The secondary outcomes include the frequency of postoperative nausea and vomiting and inflammatory markers. Data will be analyzed using intention-to-treat analysis with SPSS, using ANOVA, chi-square, and nonparametric tests as appropriate. RESULTS: This trial is currently in progress, having received funding in January 2023 and July 2023. Participant recruitment commenced on November 1, 2024, with an anticipated completion date of October 30, 2026. As of January 2026, a total of 38 pediatric patients have been enrolled and randomized, while data collection and intervention delivery are ongoing. No interim analysis has been conducted. The final analysis will begin after recruitment and follow-up are complete, with primary results expected to be published in the second half of 2026. CONCLUSIONS: This study is the first to rigorously assess the efficacy and potential synergistic effects of acupoint massage and mirabilite application for enhancing gastrointestinal recovery after pediatric ERCP. Positive findings could establish a safe, nonpharmacological protocol to improve postoperative outcomes, reduce hospital stays, and minimize complications in this vulnerable population. TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry ITMCTR2025000670; https://itmctr.ccebtcm.org.cn/mgt/project/view/3385640124071694411. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/87961.