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Could a tiny dye dose prevent bile duct injuries during gallbladder removal?

NCT ID NCT07195331

Disease control Sponsor: Instituto de Investigación Biomédica de Salamanca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial compares two doses of a dye called indocyanine green (ICG) given before laparoscopic gallbladder removal. The dye helps surgeons see the bile ducts clearly, which may reduce the risk of accidental injury. One group gets the standard dose hours before surgery; the other gets a much lower dose just 15–30 minutes before. The study will enroll 122 adults in Spain to see if the lower dose works just as well.

What this could mean

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

Active substance
indocyanine green (ICG)
What this could lead to
If successful, this could make a safer, more convenient dye-dosing routine standard for gallbladder surgery, potentially reducing bile duct injuries.
What could go wrong
This is a small, early-phase trial (122 participants) comparing two doses; it may not show a clear difference, and results may not apply to all patients or surgical settings.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 122 people

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

Started

Feb 2026

Expected to finish

Jan 2027

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. * Signed informed consent. * Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps). Exclusion Criteria: * Age \<18 years. * Pregnancy or lactation. * Chronic kidney disease (stage \>IIIb). * ICG allergy. * Allergy to other iodinated contrast * Functional thyroid disease. * Emergency non-deferrable surgery. * Open approach. * Suspicion of gallbladder cancer. * Inability to understand the study.

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Conditions

The condition(s) this trial relates to.

cholelithiasis polyp of gallbladder

As listed by the trial registrant

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

Laparoscopic cholecystectomy surgery

How to take part

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

  1. The places running it

    2 sites. 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

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, Salamanca, 37006, Spain

  • Hospital Virgen de la Concha

    NOT_YET_RECRUITING

    Zamora, Zamora, 49022, Spain

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