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NCT Number: NCT06623513

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

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.

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Key information

Conditions

Pancreatitis, Acute Cholangiopancreatography, Endoscopic Retrograde Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parecoxib Sodium

Drug

Parecoxib Sodium 40 mg administered intravenously 30 minutes before the ERCP procedure.

Indomethacin suppository

Drug

Indomethacin suppository 100 mg administered rectally 30 minutes before the ERCP procedure.

Primary outcomes

  1. Incidence of Post-ERCP Pancreatitis (PEP)

    Time frame: 24 hours after ERCP procedure.

    The primary outcome is the proportion of patients who develop post-ERCP pancreatitis. PEP is characterized by new or worsened abdominal pain, elevated serum amylase levels (≥3 times the upper normal limit).

Secondary outcomes

  1. Incidence of Moderate to Severe PEP

    Time frame: At discharge (up to 30 days)

    The severity of PEP will be classified according to the Cotton consensus and the revised Atlanta classification.

  2. Incidence of Hyperamylasemia

    Time frame: 3 and 24 hours after ERCP procedure

    Hyperamylasemia is defined as a serum amylase level greater than three times the upper limit of normal, without the onset of new abdominal pain or worsening of existing pain.

  3. 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)

    Definition: Post-ERCP discomfort symptoms primarily include abdominal pain, nausea, vomiting, sore throat, abdominal bloating, dizziness, and headache. To comprehensively assess the severity of these symptoms, the study will utilize the Symptom Severity Index (SSI) to quantify and analyze patient-reported symptoms.

    Assessment Method: Each symptom will be self-assessed by the patient using the Numeric Rating Scale (NRS), a self-assessment tool, and verified by the study staff. The score ranges from 0 to 10, where 0 represents no symptoms, and 10 represents the most severe symptoms.

    Scoring Weights: The final score for each symptom will be calculated by multiplying the symptom score by its respective weight. The total symptom score will be the sum of all weighted scores, with a maximum score of 100.

  4. 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)

    Symptom-driven detection methods will be used to evaluate adverse events. The severity of bleeding, perforation, and cholangitis will be assessed according to the Cotton criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Ge Yu, MD

CONTACT

[email protected]

021-63240090-9185

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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

Acronym: PRECISE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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