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New dye formula could make emergency gallbladder surgery safer

NCT ID NCT07551388

Symptom relief Sponsor: Peking Union Medical College Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested a personalized dose of a dye called indocyanine green (ICG) to help surgeons see bile ducts more clearly during emergency gallbladder removal. 21 patients with acute cholecystitis received a dye dose calculated from their MRI scans. The goal was to improve surgical safety by reducing the risk of bile duct injury.

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) dye
What this could lead to
If successful, this could provide a safer, clearer way for surgeons to see bile ducts during emergency gallbladder removal, reducing the risk of injury.
What could go wrong
This is a small, early-phase study with only 21 participants, so results may not apply to all patients. The dye may still not provide clear images in some cases.

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

21 people

The number who actually took part.

Started

Jan 2025

Finished

Oct 2025

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 to 80 years

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 undergoing emergency laparoscopic cholecystectomy. * Diagnosis of moderate to severe acute cholecystitis according to the 2018 Tokyo Guidelines. * Preoperative MRI available for common bile duct wall thickness measurement. * Ability to provide informed consent. Exclusion Criteria: * Known allergy or contraindication to indocyanine green (ICG). * Severe renal or hepatic dysfunction (eGFR \<30 mL/min/1.73m² or Child-Pugh class B/C cirrhosis). * Pregnancy or breastfeeding. * Previous biliary surgery or known choledocholithiasis requiring preoperative intervention. * Unstable hemodynamic status requiring conversion to open surgery before ICG administration.

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Conditions

The condition(s) this trial relates to.

acute cholecystitis

As listed by the trial registrant

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

Acute cholecystitis

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.