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NCT Number: 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

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.

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Key information

Conditions

Pancreas Disease Digestive System Diseases Pancreatic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asian institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500079, India

Location status: Recruiting

Location contact

Rajesh Goud Mr Maragoni, M.Pharm, MBA

CONTACT

[email protected]

04023378888 ext. 531

Zaheer Nabi Dr Mohammed, MBBS, MD

CONTACT

[email protected]

04023378888 ext. 102

About this study

  • 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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Categorisation of Post ERCP Pancreatitis

    Time frame: 10 Days

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

Secondary outcomes

  1. Serum amylase and lipase 24 hours post ERCP.

    Time frame: 24 hours

    To evaluate the serum amylase and lipase levels 24 hours after ERCP procedure

  2. Abdomen pain score assessment

    Time frame: 24 hours

    To check pain levels every 4 hours up to 24 hours post ERCP procedure

  3. Adverse events detection : GI bleeding, perforation, cholangitis, aspiration, hypoxemia

    Time frame: 24 hours

    To detect adverse events post procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Mohana Dr Prafullah, MD DNB

CONTACT

[email protected]

04023378888 ext. 427

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

CONTACT

[email protected]

04023378888 ext. 312

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Acronym: ERCP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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