Fluorescent bile duct imaging with standard versus reduced indocyanine green doses during laparoscopic gallbladder removal
Reduced Dose vs Standard Dose of Indocyanine Green in Near-infrared Fluorescence Cholangiography During Laparoscopic Cholecystectomy: a Randomized Clinical Trial.
This will see if a much lower dose of indocyanine green given shortly before laparoscopic gallbladder removal shows the bile ducts as well as the standard higher dose given hours earlier.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Biomédica de Salamanca Academic / other |
| Locations | 2 sites (Salamanca, Salamanca and 1 other locations) |
| Trial ID | NCT07195331 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for elective laparoscopic cholecystectomy for symptomatic gallstones or gallbladder polyps who can give informed consent and do not have contraindications to ICG or the listed exclusions are ideal candidates.
Not a fit: Patients with emergency non-deferrable surgery, pregnancy or lactation, ICG or iodinated contrast allergy, advanced CKD, functional thyroid disease, suspected gallbladder cancer, or those requiring an open approach are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the reduced-dose, immediate-preoperative approach could provide equally clear bile duct images with less dye exposure, lower liver background signal, and greater logistical convenience for patients and surgical teams.
How similar studies have performed: ICG fluorescence cholangiography is an established method that has improved bile duct visualization in prior studies, although optimal dosing and exact timing—especially very low immediate preoperative doses—are still being defined.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Salamanca, Salamanca and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.