RecruitingPhase 3NCT03713879

Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis

Comparative Effectiveness Between Rectally Administered Indomethacin and Pancreatic Stenting in the Prevention of Post Endoscopic Retrograde Cholangio-panceaticography (ERCP) Pancreatitis: a Randomized Trial


Sponsor

Chinese University of Hong Kong

Enrollment

1,734 participants

Start Date

Mar 21, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP. The comparative effectiveness of the two methods has however not been studied. It is argued that in the context of indomethacin, the placement of a PDS is unnecessary. Advocates for PDS insertion however believe that mechanical decompression of the pancreatic duct is critical in the prevention of pancreatitis. The investigators propose a multi-centre randomised controlled trial to compare the use of rectal indomethacin to PDS insertion in high risk patients in the prevention of PEP.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods for preventing pancreatitis (inflammation of the pancreas) after a common stomach procedure called ERCP (endoscopic retrograde cholangiopancreatography). ERCP is used to examine the bile ducts and pancreas, but it can sometimes cause the pancreas to become inflamed. The two methods being compared are: a suppository medication called indomethacin (an anti-inflammatory drug) and a small plastic tube (pancreatic stent) placed temporarily in the pancreatic duct. Participants are patients who are already having ERCP and are considered at higher risk for post-procedure pancreatitis. The study aims to find which method better prevents this painful complication, helping doctors make evidence-based decisions during ERCP procedures. You may be eligible if: - You are 18 or older and scheduled for ERCP - You have at least one risk factor for post-ERCP pancreatitis (such as a history of it, difficult bile duct access, or certain anatomical features) You may NOT be eligible if: - You are pregnant or breastfeeding - You have a known allergy to NSAIDs (like ibuprofen or indomethacin) - You have active gastrointestinal bleeding - You have kidney failure (creatinine above 140) - You have heart failure - You have unusual digestive anatomy (other than certain types of previous stomach surgery) - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEpancreatic stenting

a PD stent to be inserted during ERCP (a 3 to 5 cm 5Fr single pigtail pancreatic duct stent without inner flap is used, the stent is inserted after deep cannulation of pancreatic duct with a .025" or .035" wire)

DRUGIndomethacin

rectally administered indomethacin before or after ERCP


Locations(7)

Endoscopy centre

Xi'an, Shaanxi, China

Eastern Hepatobiliary Surgery Hospital,Endoscopy centre

Shanghai, Shanghai Municipality, China

Endoscopy centre

Shanghai, Shanghai Municipality, China

Endoscopy centre

Tianjin, Tianjin Municipality, China

Endoscopy centre

Hangzhou, Zhejiang, China

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, Hong Kong, Hong Kong

2. Chulalongkorn University and King Chulalongkorn Memorial Hospital

Bangkok, Thailand

View Full Details on ClinicalTrials.gov

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NCT03713879


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