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(s) studied

Study 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

Primary outcome measure(s)

• Categorisation of Post ERCP Pancreatitis — 10 Days
  Incidence of Post ERCP Pancreatitis by Cotton criteria: severity graded as mild/ moderate/ severe per consensus

Trial sites (1)

More Asian Institute of Gastroenterology, India trials in India

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