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

NCT06623513 | Not Yet Recruiting Phase 2

• 1 other identifier: CCTR-2023C01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Parecoxib; Indomethacin; Post-ERCP Pancreatitis; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-ERCP Pancreatitis (PEP)

  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).

  24 hours after ERCP procedure.

Secondary Outcomes (4)

• Incidence of Moderate to Severe PEP

  At discharge (up to 30 days)

• Incidence of Hyperamylasemia

  3 and 24 hours after ERCP procedure

• Post-Procedure Discomfort Symptoms

  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

  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)

Study Arms (2)

Parecoxib Group

EXPERIMENTAL

Drug: Parecoxib Sodium

Indomethacin Group

ACTIVE COMPARATOR

Drug: Indomethacin suppository

Interventions

Parecoxib Sodium DRUG

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

Parecoxib Group

Indomethacin suppository DRUG

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

Indomethacin Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Pancreatitis

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Ge Yu, MD

CONTACT

021-63240090-9185; ge.yu@shgh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Gastroenterology Department

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share