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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatitis, Acute; Cholangiopancreatography, Endoscopic Retrograde
• Intervention / Treatment: Drug: Parecoxib Sodium; Drug: Indomethacin suppository

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ge Yu, MD; Phone Number: 021-63240090-9185; Email: ge.yu@shgh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parecoxib Group	Drug: Parecoxib Sodium; Parecoxib Sodium 40 mg administered intravenously 30 minutes before the ERCP procedure.
Active Comparator: Indomethacin Group	Drug: Indomethacin suppository; Indomethacin suppository 100 mg administered rectally 30 minutes before the ERCP procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Moderate to Severe PEP	The severity of PEP will be classified according to the Cotton consensus and the revised Atlanta classification.	At discharge (up to 30 days)
Incidence of Hyperamylasemia	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 and 24 hours after ERCP procedure
Post-Procedure Discomfort Symptoms	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.	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	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.	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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Parecoxib; Indomethacin; Post-ERCP Pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Cyclooxygenase 2 Inhibitors; Gout Suppressants; Tocolytic Agents; Indomethacin; Parecoxib
• Other Study ID Numbers: CCTR-2023C01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No