Cold water rinse may cut pancreatitis risk after ERCP

NCT ID NCT07574970

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Recruiting now This study
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether rinsing the bile duct opening with cold water, in addition to standard rectal indomethacin, can better prevent pancreatitis after ERCP—a common procedure to treat bile or pancreas issues. About 150 adults in India will be randomly assigned to get either the combination or indomethacin alone. The main goal is to see if the combo lowers the rate of post-procedure pancreatitis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rectal indomethacin plus cold water irrigation of the ampulla
What this could lead to
If it works, this could offer a simple, low-cost way to further reduce the risk of pancreatitis after a common bile duct procedure.
What could go wrong
This is a small, early-stage study (150 people) testing a new combination. The added benefit of cold water may be small or absent, and the procedure carries its own risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

150

Ages

18 to 60 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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Contacts and locations

Locations

  • Asian institute of Gastroenterology/AIG Hospitals

    RECRUITING

    Hyderabad, Telangana, 500079, India

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