Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398028
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
The Preoperative Administration of ICG Indocyanine Green Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None