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Study identifier: NCT07574970 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: Pancreas Disease  ·  Sponsor: Asian Institute of Gastroenterology, India

PhaseN/A
Planned participants150
Who can joinAll sexes, 18 Years to 60 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA  ·  04023378888  ·  rajeshgoud761@gmail.com

Mohana Dr Prafullah, MD DNB  ·  04023378888  ·  mona.prafullah@gmail.com

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Locations (1)

Asian institute of Gastroenterology/AIG HospitalsHyderabad, Telangana, IndiaRecruiting

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Source record: clinicaltrials.gov/study/NCT07574970