Not Yet RecruitingPhase 2

Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis

100 participantsStarted 2024-10-01

Plain-language summary

This study aims to evaluate the efficacy and safety of parecoxib versus indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). It is a single-center, prospective, randomized, controlled, exploratory trial. Participants will be randomly assigned to receive either parecoxib or indomethacin as a preventive treatment. The primary endpoint is to compare the efficacy of the two drugs in reducing the incidence of PEP. Secondary endpoints include the incidence of moderate to severe PEP and post-ERCP-related adverse events. This study will systematically assess the efficacy and safety of both drugs, providing preliminary data for future larger confirmatory trials.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 80 years. * Patients scheduled to undergo ERCP for conditions such as common bile duct stones, benign or malignant biliary strictures, cholangitis, suspected biliary tumors, unexplained jaundice, or pancreas divisum. Exclusion Criteria: * Previous papillectomy. * Previous endoscopic sphincterotomy (EST) without planned pancreatic duct intervention. * Simple biliary stent removal or replacement without planned pancreatic duct intervention. * Biliary-duodenal fistula, post-biliary-duodenal anastomosis, or post-biliary-jejunal anastomosis. * Malignant tumor of the pancreatic head. * Currently or recently (within 1 week) suffering from acute pancreatitis. * Current or recent (within 1 week) use of NSAIDs. * Recent (within 2 weeks) or within 4 weeks prior to surgery, gastrointestinal bleeding or peptic ulcers. * History of significant adverse reactions to NSAIDs. * Renal insufficiency (creatinine clearance \< 30 mL/min). * Moderate to severe hepatic impairment (Child-Pugh score ≥ 7). * Severe cardiovascular or cerebrovascular disease. * Patients with psychiatric disorders. * Pregnant or breastfeeding patients. * Patients without a rectum. * Patients unwilling or unable to provide informed consent.

What they're measuring

Incidence of Post-ERCP Pancreatitis (PEP)

Timeframe: 24 hours after ERCP procedure.

Trial details

NCT IDNCT06623513

SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Ge Yu, MD

021-63240090-9185 ge.yu@shgh.cn