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A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF POST-ERCP PANCREATITIS -RCT

Recruitingn/aAges 18 Years - 60 YearsAllAsian Institute of Gastroenterology, India
NCT07574970 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Endoscopic retrograde cholangiopancreatography (ERCP) has emerged as the primary modality in the management of biliary and pancreatic disease. The complications occurring from ERCP can range from mild to fatal. Procedure related complications are Pancreatitis , Bleeding , Infections- Cholangitis, Cholecystitis , Perforations of which Post-ERCP pancreatitis (PEP) is the most common serious adverse event. Reported incidence of PEP is 8.6-10.7% according to studies(overall RCTs).In India it is 6.6% (2020 study). Prevention as well as early detection and management of PEP results in a satisfactory outcome. Multiple RCTs and meta-analyses show rectal indomethacin/diclofenac significantly reduce PEP in average- and high-risk patients; now recommended by ASGE/ESGE for nearly all ERCPs. Other measures for prevention of PEP are prophylactic pancreatic duct stents in high-risk anatomy/instrumentat

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Standard ERCP indication 2. Consent given Exclusion Criteria: 1. Pregnancy and lactation 2. Chronic calcific pancreatitis / pancreatic divisum / pancreatic head 3. malignancy / acute pancreatitis within 14 days of ERCP 4. ERCP for biliary/pancreatic stent exchange or removal or prior biliary sphincterotomy 5. Chronic kidney disease with GFR \<30 or acute kidney injury. 6. Presence of rectal anomaly 7. Active GI bleeding or high bleeding risk precluding NSAIDs;platelet \<50000/L;INR \>1.5 not correctable 8. NSAID allergy 9. Cirrhosis Child-Pugh C 10. Temp instability or severe cardiopulmonary disease precluding cooling/shock risk. 11. Sphincter of Oddi dysfunction (Type 3)
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What it tests

  • Not listed
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Where

1 site
Asian institute of Gastroenterology/AIG Hospitals
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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