Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

October 15, 2025

Primary Completion Date

November 15, 2026

Study Completion Date

January 31, 2027

Conditions
Laparoscopic Cholecystectomy Surgery
Interventions
DRUG

Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.

A dilution will be prepared by dissolving 25 mg of ICG in 10 mL of water for injectable solutions, yielding a concentration of 2.5 mg/mL. Once the solution is prepared, 1 mL will be administered directly via a peripheral venous line in the patient's upper limb.

DRUG

Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.

A dilution will be prepared by dissolving 25 mg of ICG in 25 mL of water for injectable solutions, yielding a concentration of 1 mg/mL. Subsequently, 0.25 mL will be administered as a direct intravenous injection via a peripheral venous line in the patient's upper limb.

Trial Locations (2)

37006

Hospital Universitario de Salamanca, Salamanca

49022

Hospital Virgen de la Concha, Zamora

All Listed Sponsors
collaborator

Spanish Association of Surgeons (AEC)

OTHER

lead

Instituto de Investigación Biomédica de Salamanca

OTHER