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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Parecoxib Sodium
  • Indomethacin suppository

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations