Study protocol for a multicentre, randomised controlled trial of the external use of mirabilite to prevent pancreatitis in children after endoscopic retrograde cholangiopancreatography.

Abstract

Background Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP) in children. To date, there is no suitable medicine for post-ERCP pancreatitis prophylaxis in children and few study has prospectively evaluated an intervention to prevent post-ERCP pancreatitis in children. Mirabilite, a well-known traditional Chinese medicine(TCM) has good therapeutic effects on acute pancreatitis and no side effect for children by basic research and clinical studies. Our protocol is designed to assess the efficacy and safety of the external use of mirabilite to prevent post-ERCP pancreatitis in children. Methods/design: 520 patients planned for diagnostic and therapeutic ERCP will be enrolled according to the eligibility criteria‎. The patients will be randomly divided into two equal groups (Mirabilite and control, the external use of mirabilite in a bag on the projected abdominal area over the pancreas within 30 min before ERCP). The primary end point is incidence of post-ERCP pancreatitis. Secondary end points include abdominal pain scores, the levels of inflammatory markers [tissue necrosis factor (TNF)-α, IL-6, and IL-8] and intestinal barrier function markers (diamine oxidase, D-lactic acid, and endotoxin). Additionally, the side effects of topical mirabilite is investigated. Conclusion This trial would be the first experiment to determine mirabilite to prevent post-ERCP pancreatitis in children. Mirabilite maybe provide potential clinical benefits and a new avenue with tremendous potential for the future preventing of post-ERCP pancreatitis. Trial registration number: ChiCTR1900022642. Registered on 19 April 2019- Retrospectively registered, http://www.chictr.org.cn.