Rectal indomethacin plus cold-water ampullary cooling to lower pancreatitis after ERCP
Official title: 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 PEP
Run by Asian Institute of Gastroenterology, India · NCT07574970 · Data updated 2026-11-12
This will test whether adding cold-water cooling of the ampulla to standard rectal indomethacin lowers the chance of pancreatitis in adults having ERCP.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | July 10, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07574970 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for a standard ERCP who can receive rectal NSAIDs and give informed consent are the ideal candidates.
✕Probably not a fit
People with NSAID allergy, active high bleeding risk, recent pancreatitis, severe renal failure, pregnancy, or certain pancreatic anatomy/pathology excluded from the protocol would not be eligible and would not benefit from this intervention in this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-centre, randomized pilot superiority trial at the Asian Institute of Gastroenterology in Hyderabad that randomizes adults undergoing ERCP to receive rectal indomethacin alone or rectal indomethacin plus cold-water exposure of the ampulla. The primary outcome is the incidence of post-ERCP pancreatitis (PEP), with secondary outcomes including PEP severity, adverse events, hospital/ICU stay, and feasibility and adherence to the cooling protocol. The trial will follow participants for 30 days after their procedure and is planned over a 12-month recruitment period. Subgroup analyses will explore effect modification by baseline PEP risk, diagnostic versus therapeutic ERCP, and use of prophylactic pancreatic stents.
Why it matters
Potential benefit: If successful, adding cold-water ampullary cooling to rectal indomethacin could reduce rates and severity of post-ERCP pancreatitis and shorten hospital stays.
How similar studies have gone: Rectal NSAIDs (indomethacin/diclofenac) are well supported by RCTs and guidelines for PEP prevention, while cold-water ampullary cooling is a newer approach with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Asian institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, India Recruiting
Study contacts
- Study coordinator: Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA
- Email: rajeshgoud761@gmail.com
- Phone: 04023378888
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.