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Cold saline rinse after ERCP may prevent pancreatitis

NCT ID NCT07381478

Prevention Sponsor: Universidad Nacional de Colombia 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether rinsing the duodenal papilla with cold (3°C) sterile saline right after an ERCP procedure can lower the risk of post-ERCP pancreatitis. 900 adults in Colombia were randomly assigned to receive the cold saline rinse or standard care. The main goal was to see how many developed pancreatitis within 24 hours.

What this could mean

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

Active substance
cold sterile saline (3°C)
What this could lead to
If it works, this simple cooling technique could become a standard way to prevent a common and painful complication of ERCP.
What could go wrong
This is a combined Phase 2/3 trial, so results are still preliminary. The cooling effect may not be strong enough to prevent pancreatitis, and there is a small risk of side effects like chills or minor 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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

900 people

The number who actually took part.

Started

Aug 2025

Finished

Jan 2026

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:\*\* * Adults \*\*18 years of age or older\*\* * \*\*Native (unmodified) duodenal papilla\*\* * Scheduled for \*\*diagnostic or therapeutic ERCP\*\* \*\*Exclusion Criteria:\*\* * \*\*Inaccessible papilla\*\* or papilla \*\*surgically altered/modified\*\* * \*\*Ongoing acute or chronic pancreatitis\*\* * \*\*Pregnancy\*\* * \*\*Ethical or medical contraindications to ERCP\*\* * \*\*Lack of informed consent\*\*

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Conditions

The condition(s) this trial relates to.

pancreatitis acute pancreatitis prevention target

As listed by the trial registrant

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

Pancreatitis

Contacts and locations

Locations

  • Hospital San Rafael de Facatativá

    Bogotá, Bogota D.C., 110111, Colombia

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