Actively Recruiting
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
Led by Asian Institute of Gastroenterology, India · Updated on 2026-05-12
150
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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/instrumentation; wire-guided cannulation; minimizing PD contrast; periprocedural aggressive lactated Ringer's hydration. Cryoprevention effect was shown to reduce postprocedure papillary edema and thus lower the risk of PEP 1. Rectal NSAIDs reduce but do not eliminate PEP. 2. Cold-water ampullary cooling is biologically plausible but under-studied. 3. First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect. 4. First study in Indian population.
CONDITIONS
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 POST-ERCP PANCREATITIS -RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing ERCP for a standard medical reason
- Ability and willingness to provide consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Chronic calcific pancreatitis, pancreatic divisum, pancreatic head cancer, or acute pancreatitis within 14 days before ERCP
- ERCP performed for biliary or pancreatic stent exchange, removal, or after prior biliary sphincterotomy
- Chronic kidney disease with estimated filtration rate below 30 or recent acute kidney injury
- Presence of rectal abnormalities
- Active gastrointestinal bleeding or high bleeding risk preventing NSAID use; platelet count below 50000/L; uncorrectable INR above 1.5
- Allergy to NSAIDs
- Severe liver disease classified as Child-Pugh C cirrhosis
- Temperature instability or severe heart or lung disease making cooling unsafe
- Diagnosed with Type 3 Sphincter of Oddi dysfunction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Asian institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, India, 500079
Actively Recruiting
Research Team
R
Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA
CONTACT
M
Mohana Dr Prafullah, MD DNB
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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