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

Shanghai Jiao Tong University

Status and phase

Not yet enrolling

Phase 2

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Pancreatitis, Acute

Treatments

Drug: Parecoxib Sodium

Drug: Indomethacin suppository

Study type

Interventional

Funder types

Other

Identifiers

NCT06623513

CCTR-2023C01

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.