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Chilled water may curb pancreatitis risk after Bile-Duct procedure

NCT ID NCT07738094

Prevention Sponsor: Instituto do Cancer do Estado de São Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This trial tests whether rinsing the bile-duct opening with ice-cold water, on top of standard anti-inflammatory medication, can lower the chance of pancreatitis after an ERCP procedure. About 462 adults who need an ERCP will receive either the usual NSAID pill alone or the NSAID plus a cold-water rinse. The goal is to see if the cold-water addition reduces 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
irrigation of the duodenal papilla with ice-cold distilled water plus rectal indomethacin (NSAID)
What this could lead to
If it works, this simple, low-cost addition could significantly reduce the risk of pancreatitis after a common bile-duct procedure.
What could go wrong
This is a single-center trial, and the ice-water technique has not been tested alongside standard NSAID care. Results may not apply to all hospitals or patient groups.

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 583 people

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

Started

Jun 2026

Expected to finish

Aug 2028

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: * Patients aged 18 years or older * Clinical indication for ERCP * Presence of native major duodenal papilla without previous manipulation * Ability of the patient or companion to provide informed consent. Exclusion Criteria: * Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation) * Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved) * Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions) * Pregnant women * Refusal to participate in the study or inability to sign the ICF * Contraindication to NSAID use.

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Conditions

The condition(s) this trial relates to.

acute pancreatitis pancreatitis

As listed by the trial registrant

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

Pancreatitis, acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brasil.

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

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