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

RecruitingPhase 4Ages 18 Years - anyAllInstituto de Investigación Biomédica de Salamanca
NCT07195331 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 cholangiography during laparoscopic cholecystectomy (LC)-the current gold standard treatment for symptomatic cholelithiasis. Despite its effectiveness, LC is still associated with significant risks, particularly bile duct injury (BDI), a severe complication that this study aims to mitigate. Phase: Phase IV Study design: Multicenter, randomized, open-label, parallel-group clinical trial (modified intention-to-treat). Objectives: Primary objective: * To analyze differences between treatment groups (standard dose 2.5 mg \>3h preoperative vs reduced dose 0.25 mg immediate preoperative 15-30 min) during laparoscopic cholecystectomy in: * Visualization of extrahepatic biliary structures * Degree of vi

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.
  • Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.
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Where

2 sites
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Virgen de la Concha
Zamora, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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