The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine green.
- Who it may be relevant to
- Registry conditions: Liver Tumor; Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Preoperative Administration of ICG (Indocyanine Green) Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
Overview
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, operation time, conversion to open surgery rate, length of hospital stay, liver tumor recurrence, readmission rate, complications, and 90-day mortality. This research seeks to advance tumor detection methods and improve patient outcomes in minimally invasive liver resection procedures.
Interventions
- Drug Indocyanine green
Indocyanine green has a sharply defined spectral peak absorption of near-infrared light at 800 nm in blood plasma or blood. This is the same wavelength at which the optical density of oxygenated hemoglobin in blood approximately equals that of reduced hemoglobin. Therefore, this coincidental light absorption makes it possible to measure indocyanine green concentrations in blood, plasma and serum in terms of its optical density at 800 nm, independent of variations in oxygen saturation level
Primary outcome measures
- Number of liver tumors identified intraoperatively using preoperative magnetic resonance imaging, intraoperative ultrasound, and ICG fluorescence. [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Spain · 1 center
- Hospital Universitari Vall d'Hebron — Barcelona
Publications
- Huerta M, Lopez-Ben S, Llado L, Sanchez-Cabus S, Mils K, Molina V, Dopazo C, Vidal L, Dalmau M, Caralt M, Roson N, Merino X, Armario D, Salcedo MT, Pellino G, Sapisochin G, Gomez-Gavara C; LIVERGREEN Collaborative Group. Indocyanine green fluorescence for intraoperative detection of liver tumours in minimally invasive surgery: protocol for the LIVERGREEN phase IV multicentre clinical trial. BMJ Op PMID 41991264
Identifiers
NCT: NCT06398028 · LIVERGREEN