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

Recruiting now · Phase 4

Conditions studied: Liver Tumor; Surgery

In brief

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.

Key facts

Study ID

NCT06398028

Run by

Hospital Universitari Vall d'Hebron Research Institute

People needed

173

Starts

2023-08-19

Expected to finish

2028-03-19

Last updated by the study team

2024-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Absence of exclusion criteria and able to provide consent for data collection and analysis

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.

Where it is running

• Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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