Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. 2017

Yang-Yang Qian, and Hui Chen, and Xin-Ying Tang, and Xi Jiang, and Wei Qian, and Wen-Bin Zou, and Lei Xin, and Bo Li, and Yan-Fen Qi, and Liang-Hao Hu, and Duo-Wu Zou, and Zhen-Dong Jin, and Dong Wang, and Yi-Qi Du, and Luo-Wei Wang, and Feng Liu, and Zhao-Shen Li, and Zhuan Liao
Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, 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 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. CONCLUSIONS 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. BACKGROUND ClinicalTrials.gov, ID: NCT02797067 . Registered on 17 November 2016.

UI MeSH Term Description Entries
D007213 Indomethacin A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES. Amuno,Indocid,Indocin,Indomet 140,Indometacin,Indomethacin Hydrochloride,Metindol,Osmosin
D008096 Lithotripsy The destruction of a calculus of the kidney, ureter, bladder, or gallbladder by physical forces, including crushing with a lithotriptor through a catheter. Focused percutaneous ultrasound and focused hydraulic shock waves may be used without surgery. Lithotripsy does not include the dissolving of stones by acids or litholysis. Lithotripsy by laser is LITHOTRIPSY, LASER. ESWL (Extracorporeal Shockwave Lithotripsy),Electrohydraulic Shockwave Lithotripsy,Extracorporeal Shockwave Lithotripsy,Litholapaxy,Noninvasive Litholapaxy,Percutaneous Ultrasonic Lithotripsy,Ultrasonic Lithotripsy,ESWLs (Extracorporeal Shockwave Lithotripsy),Electrohydraulic Shockwave Lithotripsies,Extracorporeal Shockwave Lithotripsies,Litholapaxies,Litholapaxies, Noninvasive,Litholapaxy, Noninvasive,Lithotripsies,Lithotripsies, Electrohydraulic Shockwave,Lithotripsies, Extracorporeal Shockwave,Lithotripsies, Percutaneous Ultrasonic,Lithotripsies, Ultrasonic,Lithotripsy, Electrohydraulic Shockwave,Lithotripsy, Extracorporeal Shockwave,Lithotripsy, Percutaneous Ultrasonic,Lithotripsy, Ultrasonic,Noninvasive Litholapaxies,Percutaneous Ultrasonic Lithotripsies,Shockwave Lithotripsies, Electrohydraulic,Shockwave Lithotripsies, Extracorporeal,Shockwave Lithotripsy, Electrohydraulic,Shockwave Lithotripsy, Extracorporeal,Ultrasonic Lithotripsies,Ultrasonic Lithotripsies, Percutaneous,Ultrasonic Lithotripsy, Percutaneous
D010195 Pancreatitis INFLAMMATION of the PANCREAS. Pancreatitis is classified as acute unless there are computed tomographic or endoscopic retrograde cholangiopancreatographic findings of CHRONIC PANCREATITIS (International Symposium on Acute Pancreatitis, Atlanta, 1992). The two most common forms of acute pancreatitis are ALCOHOLIC PANCREATITIS and gallstone pancreatitis. Acute Edematous Pancreatitis,Acute Pancreatitis,Pancreatic Parenchyma with Edema,Pancreatic Parenchymal Edema,Pancreatitis, Acute,Pancreatitis, Acute Edematous,Peripancreatic Fat Necrosis,Acute Edematous Pancreatitides,Acute Pancreatitides,Edema, Pancreatic Parenchymal,Edematous Pancreatitides, Acute,Edematous Pancreatitis, Acute,Fat Necrosis, Peripancreatic,Necrosis, Peripancreatic Fat,Pancreatic Parenchymal Edemas,Pancreatitides, Acute,Pancreatitides, Acute Edematous,Parenchymal Edema, Pancreatic,Peripancreatic Fat Necroses
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D002137 Calculi An abnormal concretion occurring mostly in the urinary and biliary tracts, usually composed of mineral salts. Also called stones. Biliary or Urinary Stones,Calculus
D002681 China A country spanning from central Asia to the Pacific Ocean. Inner Mongolia,Manchuria,People's Republic of China,Sinkiang,Mainland China
D002985 Clinical Protocols Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy. Protocols, Clinical,Research Protocols, Clinical,Treatment Protocols,Clinical Protocol,Clinical Research Protocol,Clinical Research Protocols,Protocol, Clinical,Protocol, Clinical Research,Protocols, Clinical Research,Protocols, Treatment,Research Protocol, Clinical,Treatment Protocol
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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