Clinical trial NCT06398028: The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
Official title: The Preoperative Administration of ICG (Indocyanine Green) Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liver Tumor; Surgery
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric low-intervention phase IV clinical trial of preoperative ICG administration for intraoperative detection of liver tumors
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Number of liver tumors identified intraoperatively using preoperative magnetic resonance imaging, intraoperative ultrasound, and ICG fluorescence.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
References: