NCT06398028 The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.
| NCT ID | NCT06398028 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Liver Tumor; Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 173 participants |
| Start Date | 2023-08-19 |
| Primary Completion | 2026-03-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 173 participants in total. It began in 2023-08-19 with a primary completion date of 2026-03-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06398028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Tumor; Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06398028 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06398028 currently recruiting?
Yes, NCT06398028 is actively recruiting participants. Contact the research team at concepcion.gomez@vallhebron.cat for enrollment information.
Where is the NCT06398028 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06398028 clinical trial?
NCT06398028 is sponsored by Hospital Universitari Vall d'Hebron Research Institute. The trial plans to enroll 173 participants.