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

NCT06623513 PHASE2 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase	PHASE2
Status	NOT_YET_RECRUITING
Enrolment	100
Start date	Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Sep 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Pancreatitis, Acute
• Cholangiopancreatography, Endoscopic Retrograde

Interventions

• Parecoxib Sodium
• Indomethacin suppository