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

Recruiting now

Conditions studied: Pancreas Disease

In brief

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.

Key facts

Study ID

NCT07574970

Run by

Asian Institute of Gastroenterology, India

People needed

150

Starts

2025-12-01

Expected to finish

2026-12-30

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Standard ERCP indication
• Consent given

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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