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

NCT07574970 | Recruiting DMC

• 1 other identifier: IWCRCT1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Rectal NSAIDs reduce but do not eliminate PEP.
2. 2.Cold-water ampullary cooling is biologically plausible but under-studied.
3. 3.First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect.
4. 4.First study in Indian population.

Conditions

Pancreas Disease

Outcome Measures

Primary Outcomes (1)

• Categorisation of Post ERCP Pancreatitis

  Incidence of Post ERCP Pancreatitis by Cotton criteria: severity graded as mild/ moderate/ severe per consensus

  10 Days

Secondary Outcomes (3)

• Serum amylase and lipase 24 hours post ERCP.

  24 hours

• Abdomen pain score assessment

  24 hours

• Adverse events detection : GI bleeding, perforation, cholangitis, aspiration, hypoxemia

  24 hours

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

150

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)

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500079, India

RECRUITING

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Mohan Dr Ramchandani, MD DM

  Asian Institute of Gastroenterology

  STUDY DIRECTOR

Central Study Contacts

Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA

CONTACT

04023378888; rajeshgoud761@gmail.com

Mohana Dr Prafullah, MD DNB

CONTACT

04023378888; mona.prafullah@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 8, 2026

Record last verified: 2025-11

Locations

IN (1)