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Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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.
Official title: A Single-Center, Prospective, Randomized, Controlled, Exploratory Trial Comparing the Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis: The PRECISE Trail
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-10-01
Completion Date
2026-09-30
Last Updated
2024-10-02
Healthy Volunteers
No
Interventions
Parecoxib Sodium
Parecoxib Sodium 40 mg administered intravenously 30 minutes before the ERCP procedure.
Indomethacin suppository
Indomethacin suppository 100 mg administered rectally 30 minutes before the ERCP procedure.