Status:
NOT_YET_RECRUITING
Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.
Lead Sponsor:
Instituto de Investigación Biomédica de Salamanca
Collaborating Sponsors:
Spanish Association of Surgeons (AEC)
Conditions:
Laparoscopic Cholecystectomy Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Introduction: This protocol outlines a randomized phase IV clinical trial designed to compare the efficacy of two different doses of indocyanine green (ICG) used in near-infrared fluorescent cholangi...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Signed informed consent.
- Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).
Exclusion
- 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.
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT07195331
Start Date
January 15 2026
End Date
January 31 2027
Last Update
December 5 2025
Active Locations (2)
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1
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain, 37006
2
Hospital Virgen de la Concha
Zamora, Zamora, Spain, 49022