Preoperative Indocyanine Green administration increases intraoperative detection of Liver Tumors in Imaging-guided surgery. A phase IV clinical trial.
Phase 1
- Conditions
- Patients with liver tumors that will undergo minimally invasive liver surgeryMedDRA version: 21.0Level: LLTClassification code: 10025630Term: Malignant liver tumour resectable Class: 10029104Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Registration Number
- CTIS2023-508316-27-00
- Lead Sponsor
- Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 173
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 (one condition will be enough for excluding the patient): 1.previous history of iodine hypersensitivity; 2. patients with renal failure (GFR <60 mL/min/1.73 m2); 3 uremic syndrome; 4. clinical hyperthyroidism; 5. autonomic thyroid adenomas; or 6. focal and diffuse autonomic abnormalities of the thyroid gland., Previous liver surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method