Qian YY et al, 2017: Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial.
Qian YY, Chen H, Tang XY, Jiang X, Qian W, Zou WB, Xin L, Li B, Qi YF, Hu LH, Zou DW, Jin ZD, Wang D, Du YQ, Wang LW, Liu F, Li ZS, Liao Z.
Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.
Digestive Endoscopy Center, Department of Anesthesiology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.
Shanghai Institute of Pancreatic Diseases, Shanghai, China.
National Clinical Research Center of Digestive Diseases, Shanghai, China.
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.
Trials. 2017 Nov 2;18(1):513. doi: 10.1186/s13063-017-2250-7. FREE ARTICLE
This article is a description of a planned randomized double-blind study aimed to get information on whether NSAID (indomethacin) administered rectally reduces the risk of post-SWL pancreatitis.
No results are so far provided. It is, however, surprising that the authors state that patients are or should be treated in supine position without giving any details of which lithotripter that is used. In my own experience stones in the pancreatic duct very often need to be treated with the patient in prone position if the shockwave source is under the table.