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

NCT06398028 | Recruiting Phase 4

• 1 other identifier: LIVERGREEN
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Tumor; Surgery

Outcome Measures

Primary Outcomes (1)

• Number of liver tumors identified intraoperatively using preoperative magnetic resonance imaging, intraoperative ultrasound, and ICG fluorescence.

  3 years

Interventions

Indocyanine green DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Concepción Gómez Gavara

CONTACT

934 89 30 00; concepcion.gomez@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric low-intervention phase IV clinical trial of preoperative ICG administration for intraoperative detection of liver tumors

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: August 19, 2023
• Primary Completion: March 19, 2026
• Study Completion (Estimated): March 19, 2028
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)