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

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Sep 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether two medications, parecoxib and indomethacin, can help prevent a complication called post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), which can occur after a specific procedure done to look at the bile ducts and pancreas. Participants in the study will be randomly assigned to receive one of these medications before their ERCP, and researchers will compare how effective each drug is at reducing the chances of developing PEP. They will also monitor for any side effects related to the medications.

To be eligible for this trial, participants need to be between 18 and 80 years old and are scheduled for an ERCP due to conditions like bile duct stones or jaundice. However, there are certain health issues that could exclude someone from participating, such as recent pancreatitis or severe kidney and liver problems. While the trial is not yet recruiting participants, it aims to provide important initial data that could lead to larger studies in the future. If you or a loved one are considering participation, you can expect careful monitoring and support throughout the process.

Gender

ALL

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.