CTIS2023-508316-27-00
Active, not recruiting
Phase 1
Preoperative Indocyanine Green administration increases intraoperative detection of Liver Tumors in Imaging-guided surgery. A phase IV clinical trial. - LIVERGREE
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron0 sites173 target enrollmentNovember 28, 2023
ConditionsPatients 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with liver tumors that will undergo minimally invasive liver surgery
- Sponsor
- Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
- Enrollment
- 173
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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 (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
Outcomes
Primary Outcomes
Not specified
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