NCT07574970 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
| NCT ID | NCT07574970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asian Institute of Gastroenterology, India |
| Condition | Pancreas Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-12-01 with a primary completion date of 2026-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Mohan Dr Ramchandani, MD DM
STUDY DIRECTOR
Asian Institute of Gastroenterology
Frequently Asked Questions
Who can join the NCT07574970 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Pancreas Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07574970 currently recruiting?
Yes, NCT07574970 is actively recruiting participants. Contact the research team at rajeshgoud761@gmail.com for enrollment information.
Where is the NCT07574970 trial being conducted?
This trial is being conducted at Hyderabad, India.
Who is sponsoring the NCT07574970 clinical trial?
NCT07574970 is sponsored by Asian Institute of Gastroenterology, India. The principal investigator is Mohan Dr Ramchandani, MD DM at Asian Institute of Gastroenterology. The trial plans to enroll 150 participants.