Cold water rinse may cut pancreatitis risk after ERCP
NCT ID NCT07574970
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
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
Show the full entry requirements Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asian institute of Gastroenterology/AIG Hospitals
RECRUITINGHyderabad, Telangana, 500079, India
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