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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial

Authors: Yang-Yang Qian, Hui Chen, Xin-Ying Tang, Xi Jiang, Wei Qian, Wen-Bin Zou, Lei Xin, Bo Li, Yan-Fen Qi, Liang-Hao Hu, Duo-Wu Zou, Zhen-Dong Jin, Dong Wang, Yi-Qi Du, Luo-Wei Wang, Feng Liu, Zhao-Shen Li, Zhuan Liao

Published in: Trials | Issue 1/2017

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Abstract

Background

Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is the first-line therapy for large pancreatic duct stones. Although it is a highly effective and safe procedure for the fragmentation of pancreatic stones, it is still not complication-free. Just like endoscopic retrograde cholangiopancreatography (ERCP), pancreatitis is the most common complication. To date, nonsteroidal anti-inflammatory drugs (NSAIDs) have proven to be the only effective prophylactic medication for post-ERCP pancreatitis and the European, American and Japanese Society for Gastrointestinal Endoscopy guidelines have recommended prophylactic rectally administered indomethacin for all patients undergoing ERCP. Given the little research about effective prevention for post P-ESWL pancreatitis, we aim to determine whether rectally administered indomethacin can reduce post-ESWL-pancreatitis.

Methods/design

The RIPEP study is a prospective, randomized, double-blinded, placebo-controlled trial. One thousand three hundred and seventy patients with chronic pancreatitis and pancreatic stones (>5 mm in diameter) treated with P-ESWL at Changhai Hospital will be randomly allocated to rectally administered indomethacin or placebo therapy before the procedure. The primary endpoint is the incidence of post-ESWL pancreatitis. Secondary endpoints include the severity of pancreatitis, occurrence rate of asymptomatic hyperamylasemia and other complications.

Discussion

The RIPEP trial is designed to show that rectally administered indomethacin reduces the development and severity of post-ESWL pancreatitis and benefits patients treated with P-ESWL.

Trial registration

ClinicalTrials.gov, ID: NCT02797067. Registered on 17 November 2016.
Appendix
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Metadata
Title
Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial
Authors
Yang-Yang Qian
Hui Chen
Xin-Ying Tang
Xi Jiang
Wei Qian
Wen-Bin Zou
Lei Xin
Bo Li
Yan-Fen Qi
Liang-Hao Hu
Duo-Wu Zou
Zhen-Dong Jin
Dong Wang
Yi-Qi Du
Luo-Wei Wang
Feng Liu
Zhao-Shen Li
Zhuan Liao
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2250-7

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