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The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.

RecruitingPhase 4Ages 18 Years - anyAllHospital Universitari Vall d'Hebron Research Inst…
NCT06398028 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Summary: Preoperative administration of indocyanine green (ICG) improves the detection of liver tumors in patients undergoing minimally invasive liver resection guided by conventional intraoperative ultrasound. The primary objectives of this study are to evaluate the efficacy of ICG fluorescence uptake in combination with intraoperative ultrasonography and preoperative magnetic resonance imaging for detecting liver tumors. Additionally, a machine-learning algorithm will be developed to enhance liver tumor detection using ICG through photographic analysis. Secondary objectives include investigating the distribution of ICG in liver tissue and its correlation with hepatic fibrosis and steatosis, as well as describing patterns of ICG uptake and their relationship with liver tumors. The study also aims to analyze various clinical outcomes such as the 30-day comprehensive complication index,

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📋 Eligibility rules (as published)
Inclusion Criteria * Patients with liver tumors with an indication for minimally invasive surgery, evaluated by the hospital's multidisciplinary liver tumor board (MDTB). * Contrast enhanced MRI within 6 weeks prior to liver surgery * ≥18 years old * Absence of exclusion criteria and able to provide consent for data collection and analysis Exclusion Criteria * Emergency surgery * Patients in which ICG is contraindicated: previous history of iodine hypersensitivity, patients with renal failure (GFR \<60 mL/min/1.73 m2), uremia, clinical hyperthyroidism, autonomic thyroid adenomas, or focal and diffuse autonomic abnormalities of the thyroid gland. * Previous liver surgery.
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What it tests

  • Indocyanine green
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Where

1 site
Hospital Universitari Vall d'Hebron
Barcelona, 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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