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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 PEP

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
View:

• Standard ERCP indication

• Consent given

Locations
Other Locations
India
Asian institute of Gastroenterology/AIG Hospitals
RECRUITING
Hyderabad
Contact Information
Primary
Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA
rajeshgoud761@gmail.com
04023378888
Backup
Mohana Dr Prafullah, MD DNB
mona.prafullah@gmail.com
04023378888
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 150
Treatments
Rectal Indomethacin plus Papilary spay of Cold saline
Intervention group: Rectal indomethacin( 100 mg suppository administered 30-60 minutes pre ERCP + cold saline irrigation (4 - 10°C, 250 mL, 2 min)
Rectal Indomethacin alone
Rectal indomethacin should be administered to the patient before 30 minutes ERCP procedure
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov