RecruitingPhase 4NCT06398028

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

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


Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

173 participants

Start Date

Aug 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a dye called ICG (indocyanine green) before surgery helps surgeons better identify and remove colorectal tumors and nearby lymph nodes during laparoscopic (minimally invasive) surgery, potentially improving cancer removal rates. **You may be eligible if...** - You have been diagnosed with colorectal cancer and are scheduled for surgery - Your surgery is planned to be laparoscopic (keyhole surgery) - You are at least 18 years old - You have adequate kidney and liver function **You may NOT be eligible if...** - You have a known allergy to iodine or ICG dye - Your surgery is an emergency procedure - You have already had prior surgery for this cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIndocyanine 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


Locations(1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

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NCT06398028


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