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Not yet recruiting NCT06623513

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

Phase II Interventional Pancreatitis, Acute Cholangiopancreatography, Endoscopic Retrograde

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parecoxib Sodium, Indomethacin suppository.
Who it may be relevant to
Registry conditions: Pancreatitis, Acute, Cholangiopancreatography, Endoscopic Retrograde. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Incidence of Post-ERCP Pancreatitis (PEP) [Time frame: 24 hours after ERCP procedure.]
Secondary outcome measures (4)
  • Incidence of Moderate to Severe PEP [Time frame: At discharge (up to 30 days)]
  • Incidence of Hyperamylasemia [Time frame: 3 and 24 hours after ERCP procedure]
  • Post-Procedure Discomfort Symptoms [Time frame: Baseline (pre-procedure), 3 hours post-procedure, 6 hours post-procedure, 12 hours post-procedure, 24 hours post-procedure, 48 hours post-procedure, 72 hours post-procedure, and at discharge (up to 30 days)]
  • Bleeding, Perforation, Cholangitis, Cardiac Adverse Events, Renal Adverse Events [Time frame: 3 hours post-procedure, 6 hours post-procedure, 12 hours post-procedure, 24 hours post-procedure, 48 hours post-procedure, 72 hours post-procedure, and at discharge (up to 30 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06623513 · CCTR-2023C01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗