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Green dye may make gallbladder surgery safer

NCT ID NCT04103762

Diagnosis Sponsor: Centre Hospitalier Universitaire, Amiens 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether a green dye injected into the blood can help surgeons see bile ducts better during gallbladder removal for acute cholecystitis, compared to the standard contrast dye. 156 adults with mild to moderate gallbladder inflammation took part. The goal was to see if the green dye could reduce the risk of bile duct injury and shorten surgery time.

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 dye
What this could lead to
If successful, this could make gallbladder surgery safer by reducing the risk of bile duct injury and shortening operation time.
What could go wrong
This is a completed, moderate-sized study, but the dye may not always provide clear images, and 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

156 people

The number who actually took part.

Started

Oct 2019

Finished

Jul 2024

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 patient (\>18 years old) * Patients requiring laparoscopic cholecystectomy for grade 1 or 2 acute gallstone cholecystitis according to Tokyo recommendations confirmed by radiological morphological examination * Acute lithiasis cholecystitis (ALC) evolving for less than 5 days * Patients affiliated to a social security scheme Exclusion Criteria: * Antecedent of biliary tract surgery * Antecedent of cholecystectomy * Contraindication to laparoscopy * Contraindication to surgery * Cholecystectomy by laparotomy out of hand * Grade 3 cholecystitis according to Tokyo recommendations * Acute alithiasis cholecystitis * Cirrhosis * Conversion for gangrenous ALC * Patient with an allergy to indocyanine green * Pregnant or lactating woman, childbearing age without effective contraception * Minor patient * Physical or psychological state that does not allow participation in the study, patient under guardianship or curatorship or patient deprived of liberty by a judicial or administrative decision (according with articles L 1121-6 and L 1121-8 of the French Public Health Code)

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Conditions

The condition(s) this trial relates to.

acute cholecystitis Lithiasis urolithiasis

As listed by the trial registrant

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

Cholangiopathy Cholecystitis, acute Lithiasis

Contacts and locations

Locations

  • CHU Amiens

    Amiens, 80480, France

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