Fluorescent bile duct imaging with standard versus reduced indocyanine green doses during laparoscopic gallbladder removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label Phase IV trial comparing two intravenous ICG dosing strategies used for near-infrared fluorescent cholangiography during elective laparoscopic cholecystectomy. Participants are randomized to receive the standard 2.5 mg dose more than three hours before surgery or a reduced 0.25 mg dose 15–30 minutes before surgery, with surgeons blinded only to allocation at analysis. Primary outcomes include visualization of extrahepatic biliary structures, degree of visualization, liver background fluorescence interference, and the perceived usefulness of the technique, analyzed on a modified intention-to-treat basis. Key exclusions include pregnancy, ICG or iodinated contrast allergy, advanced chronic kidney disease, functional thyroid disease, emergency non-deferrable surgery, suspected gallbladder cancer, and inability to consent.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario de Salamanca
  Salamanca, Salamanca, Spain Recruiting
• Hospital Virgen de la Concha
  Zamora, Zamora, Spain Not yet recruiting

Study contacts

• Principal investigator: Jaime López, Medical Degree in Surgery — Centro Asistencial Universitario de Salamanca (CAUSA)
• Study coordinator: Fátima Macho Sánchez-Simón, Project Manager
• Email: uicec.admon@ibsal.es
• Phone: +34923291200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.