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Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial.
Trials. 2017 Nov 02; 18(1):513.T

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.

Authors+Show Affiliations

Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.Department of Anesthesiology, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. zhaoshenli@hotmail.com. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China. zhaoshenli@hotmail.com. Shanghai Institute of Pancreatic Diseases, Shanghai, China. zhaoshenli@hotmail.com. National Clinical Research Center of Digestive Diseases, Shanghai, China. zhaoshenli@hotmail.com.Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China. liaozhuan@smmu.edu.cn. Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China. liaozhuan@smmu.edu.cn. Shanghai Institute of Pancreatic Diseases, Shanghai, China. liaozhuan@smmu.edu.cn. National Clinical Research Center of Digestive Diseases, Shanghai, China. liaozhuan@smmu.edu.cn.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29096689

Citation

Qian, Yang-Yang, et al. "Rectally Administered Indomethacin to Prevent post-ESWL-pancreatitis (RIPEP): Study Protocol for a Randomized Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 513.
Qian YY, Chen H, Tang XY, et al. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. Trials. 2017;18(1):513.
Qian, Y. Y., Chen, H., Tang, X. Y., Jiang, X., Qian, W., Zou, W. B., Xin, L., Li, B., Qi, Y. F., Hu, L. H., Zou, D. W., Jin, Z. D., Wang, D., Du, Y. Q., Wang, L. W., Liu, F., Li, Z. S., & Liao, Z. (2017). Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. Trials, 18(1), 513. https://doi.org/10.1186/s13063-017-2250-7
Qian YY, et al. Rectally Administered Indomethacin to Prevent post-ESWL-pancreatitis (RIPEP): Study Protocol for a Randomized Controlled Trial. Trials. 2017 Nov 2;18(1):513. PubMed PMID: 29096689.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. AU - Qian,Yang-Yang, AU - Chen,Hui, AU - Tang,Xin-Ying, AU - Jiang,Xi, AU - Qian,Wei, AU - Zou,Wen-Bin, AU - Xin,Lei, AU - Li,Bo, AU - Qi,Yan-Fen, AU - Hu,Liang-Hao, AU - Zou,Duo-Wu, AU - Jin,Zhen-Dong, AU - Wang,Dong, AU - Du,Yi-Qi, AU - Wang,Luo-Wei, AU - Liu,Feng, AU - Li,Zhao-Shen, AU - Liao,Zhuan, Y1 - 2017/11/02/ PY - 2017/05/13/received PY - 2017/10/10/accepted PY - 2017/11/4/entrez PY - 2017/11/4/pubmed PY - 2018/7/3/medline KW - ESWL KW - Indomethacin KW - Post-ESWL pancreatitis KW - Prophylaxis KW - Trial SP - 513 EP - 513 JF - Trials JO - Trials VL - 18 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29096689/Rectally_administered_indomethacin_to_prevent_post_ESWL_pancreatitis__RIPEP_:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2250-7 DB - PRIME DP - Unbound Medicine ER -