The Preoperative Administration of ICG (Indocyanine Green) Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Contact Information
Primary
Concepción Gómez Gavara
concepcion.gomez@vallhebron.cat
934 89 30 00
Time Frame
Start Date: 2023-08-19
Estimated Completion Date: 2028-03-19
Participants
Target number of participants: 173
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitari Vall d'Hebron Research Institute

This content was sourced from clinicaltrials.gov