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Chilling the pancreatic duct opening: can ice water cut Post-ERCP pancreatitis?

NCT ID NCT07826026

Prevention Sponsor: Unity Health Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Pancreatitis is a painful inflammation of the pancreas that can happen after an ERCP procedure. Doctors often give rectal indomethacin around the time of ERCP to lower that risk, but it still occurs. This trial randomly assigns adults having ERCP to receive either rectal indomethacin alone or indomethacin plus a two-minute ice water rinse of the papilla, the small opening where the bile and pancreatic ducts drain. Researchers compare how many participants in each group develop pancreatitis within 30 days.

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 ice water irrigation of the duodenal papilla
What this could lead to
If the added irrigation helps, it could give doctors a simple, low-cost way to further lower the chance of pancreatitis after ERCP.
What could go wrong
The trial is small and early, so the added irrigation may not reduce pancreatitis risk beyond indomethacin alone. Irrigation adds about two minutes to the procedure and could cause local irritation or bleeding.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Age 18 years or older. Undergoing ERCP with a native papilla. Eligible to receive rectal indomethacin. Able to provide informed consent. Willing and able to complete the required follow-up and post-procedure bloodwork. Exclusion Criteria: Known allergy, hypersensitivity, or contraindication to indomethacin or rectal NSAIDs. Active acute pancreatitis at the time of ERCP. Prior sphincterotomy or absent native papilla. Prediction of papilla inaccessibility. Pregnancy. Inability or unwillingness to provide informed consent. Any clinical circumstance in which the treating endoscopist judges study participation to be unsafe or inappropriate. Chronic pancreatitis. Pancreatic head malignancy with complete main pancreatic duct obstruction. Altered luminal anatomy, other than Billroth I.

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Conditions

The condition(s) this trial relates to.

pancreatitis

As listed by the trial registrant

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

Pancreatitis

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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