Rectal indomethacin plus cold-water ampullary cooling to lower pancreatitis after ERCP

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

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
• Enrollment: 150 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Asian Institute of Gastroenterology, India (Academic / other)
• Locations: 1 site (Hyderabad, Telangana)
• Trial ID: NCT07574970 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults scheduled for a standard ERCP who can receive rectal NSAIDs and give informed consent are the ideal candidates.

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.

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 performed: 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.

Eligibility 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 this trial is running

Hyderabad, Telangana

• Asian institute of Gastroenterology/AIG Hospitals — Hyderabad, Telangana, India (Recruiting)

Study contacts

• Study coordinator: Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA

Conditions Pancreas Disease