RecruitingNCT07574970

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 - A PILOT RCT IN INDIAN POPULATION

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


Sponsor

Asian Institute of Gastroenterology, India

Enrollment

150 participants

Start Date

Dec 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

  • Standard ERCP indication
  • Consent given

Exclusion Criteria11

  • Pregnancy and lactation
  • Chronic calcific pancreatitis / pancreatic divisum / pancreatic head
  • malignancy / acute pancreatitis within 14 days of ERCP
  • ERCP for biliary/pancreatic stent exchange or removal or prior biliary sphincterotomy
  • Chronic kidney disease with GFR <30 or acute kidney injury.
  • Presence of rectal anomaly
  • Active GI bleeding or high bleeding risk precluding NSAIDs;platelet <50000/L;INR >1.5 not correctable
  • NSAID allergy
  • Cirrhosis Child-Pugh C
  • Temp instability or severe cardiopulmonary disease precluding cooling/shock risk.
  • Sphincter of Oddi dysfunction (Type 3)

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Locations(1)

Asian institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, India

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NCT07574970


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