Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06398028

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

Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2024-05-03

173

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with liver tumors indicated for minimally invasive surgery as evaluated by the hospital's multidisciplinary liver tumor board (MDTB)
  • Contrast-enhanced MRI performed within 6 weeks before liver surgery
  • Age 18 years or older
  • Able to provide consent for data collection and analysis and do not meet exclusion criteria
Not Eligible

You will not qualify if you...

  • Emergency surgery
  • History of iodine hypersensitivity or allergy
  • Renal failure with GFR less than 60 mL/min/1.73 m2
  • Uremia
  • Clinical hyperthyroidism
  • Autonomic thyroid adenomas or focal and diffuse autonomic thyroid abnormalities
  • Previous liver surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Actively Recruiting

Loading map...

Research Team

C

Concepción Gómez Gavara

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here