Using ICG to Improve Liver Tumor Detection During Minimally Invasive Surgery
The Preoperative Administration of ICG (Indocyanine Green) Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
PHASE4 · Hospital Universitari Vall d'Hebron Research Institute · NCT06398028
This study is testing whether a special dye can help doctors find liver tumors more easily during minimally invasive surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 173 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06398028 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of preoperative indocyanine green (ICG) administration in enhancing the detection of liver tumors during minimally invasive liver surgery. It combines ICG fluorescence uptake with intraoperative ultrasound and preoperative MRI to improve tumor visibility. Additionally, a machine-learning algorithm will be developed to analyze photographic data for better tumor detection. The study also aims to assess the distribution of ICG in liver tissue and its relationship with liver conditions, while monitoring various clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults with liver tumors who are scheduled for minimally invasive surgery and have undergone a recent contrast-enhanced MRI.
Not a fit: Patients requiring emergency surgery or those with contraindications to ICG will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the accuracy of liver tumor detection, leading to better surgical outcomes for patients.
How similar studies have performed: Other studies have shown promising results with ICG in tumor detection, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Concepción Gómez Gavara
- Email: concepcion.gomez@vallhebron.cat
- Phone: 934 89 30 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Tumor, Surgery