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

NCT ID: NCT06623513

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Parecoxib Group

Group Type: EXPERIMENTAL

Parecoxib Sodium

Intervention Type: DRUG

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

Indomethacin Group

Group Type: ACTIVE_COMPARATOR

Indomethacin suppository

Intervention Type: DRUG

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

Interventions

Parecoxib Sodium

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

Intervention Type: DRUG

Indomethacin suppository

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ge Yu

Attending Physician, Gastroenterology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ge Yu, MD

Role: CONTACT

ge.yu@shgh.cn

021-63240090-9185

Other Identifiers

CCTR-2023C01

Identifier Type: -

Identifier Source: org_study_id