Actively Recruiting
The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-05-03
173
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with liver tumors indicated for minimally invasive surgery as evaluated by the hospital's multidisciplinary liver tumor board (MDTB)
- Contrast-enhanced MRI performed within 6 weeks before liver surgery
- Age 18 years or older
- Able to provide consent for data collection and analysis and do not meet exclusion criteria
You will not qualify if you...
- Emergency surgery
- History of iodine hypersensitivity or allergy
- Renal failure with GFR less than 60 mL/min/1.73 m2
- Uremia
- Clinical hyperthyroidism
- Autonomic thyroid adenomas or focal and diffuse autonomic thyroid abnormalities
- Previous liver surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
Research Team
C
Concepción Gómez Gavara
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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