NCT06623513

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatitis, Acute
• Cholangiopancreatography, Endoscopic Retrograde

Interventions

Type	Name	Description
DRUG	Parecoxib Sodium	Parecoxib Sodium 40 mg administered intravenously 30 minutes before the ERCP procedure.
DRUG	Indomethacin suppository	Indomethacin suppository 100 mg administered rectally 30 minutes before the ERCP procedure.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-10-02
• Last updated: 2024-10-02