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

Phase 2Not Yet RecruitingNCT06623513

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Pancreatitis, Acute Cholangiopancreatography, Endoscopic Retrograde

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 24 hours after ERCP procedure.

Secondary Outcomes

Incidence of Moderate to Severe PEP

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

Time frame: 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.

Time frame: 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.

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

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.

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)