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

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

NCT ID: NCT06398028

Condition: Liver Tumor; Surgery

Conditions: Official terms:
Liver Neoplasms

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Multicentric low-intervention phase IV clinical trial of preoperative ICG administration for intraoperative detection of liver tumors

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Indocyanine green
Description: 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

Summary: 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Universitari Vall d'Hebron

Address:
City: Barcelona
Country: Spain

Status: Recruiting

Contact:
Last name: Concepcion Gomez Gavara

Start date: August 19, 2023

Completion date: March 19, 2028

Lead sponsor:
Agency: Hospital Universitari Vall d'Hebron Research Institute
Agency class: Other

Source: Hospital Universitari Vall d'Hebron Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06398028