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 (ERCP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreas Disease

Detailed Description

• Assess whether combination therapy reduces PEP compared to NSAIDS alone.

Secondary Aims:

• Compare PEP severity (Cotton grading and revised Atlanta criteria).
• Adverse effects
• Length of hospital stay and/or intensive care unit stay
• Assess feasibility and adherence and fidelity of cooling protocol.
• Explore effect modification by baseline PEP risk (average vs high-risk), type of intervention (diagnostic vs therapeutic ERCP), and prophylactic pancreatic stenting use

DESIGN AND DURATION OF THE STUDY: Single centre pilot randomised control superiority trail over 12 months with 30 days followup

INCLUSION / EXCLUSION CRITERIA:

• Inclusion criteria:

  • Standard ERCP indication
  • Consent given

• Exclusion criteria:

  • 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)

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Rajesh Goud Mr Maragoni, M.Pharm,MBA,PGDCA; Phone Number: 312 04023378888; Email: rajeshgoud761@gmail.com
• Study Contact Backup: Name: Mohana Dr Prafullah, MD DNB; Phone Number: 427 04023378888; Email: mona.prafullah@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500079
      • Recruiting
      • Asian institute of Gastroenterology/AIG Hospitals
      • Contact: Rajesh Goud Mr Maragoni, M.Pharm, MBA; Phone Number: 531 04023378888; Email: rajeshgoud761@gmail.com
      • Contact: Zaheer Nabi Dr Mohammed, MBBS, MD; Phone Number: 102 04023378888; Email: zaheernabi1978@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

150

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Categorisation of Post ERCP Pancreatitis	Incidence of Post ERCP Pancreatitis by Cotton criteria: severity graded as mild/ moderate/ severe per consensus	10 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum amylase and lipase 24 hours post ERCP.	To evaluate the serum amylase and lipase levels 24 hours after ERCP procedure	24 hours
Abdomen pain score assessment	To check pain levels every 4 hours up to 24 hours post ERCP procedure	24 hours
Adverse events detection : GI bleeding, perforation, cholangitis, aspiration, hypoxemia	To detect adverse events post procedure	24 hours

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Study Director: Mohan Dr Ramchandani, MD DM, Asian Institute Of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: IWCRCT1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No