NCT03946761

Fluorescence Imaging in Hepatobiliary Surgery

Evaluation of Fluorescence Imaging in Hepatobiliary Surgery

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A current gap in the use indocyanine green fluorescence to isolate the biliary system is the dosing amount necessary to fluoresce the biliary system without "over" fluorescing the liver and gallbladder. Over fluorescing surrounding structures such as the liver and gallbladder saturates the image and makes it impossible to identify biliary leaks or differentiate branches of the common bile duct using fluorescent imaging devices. The over dosing does not affect the standard of care procedure, but eliminates the added benefit of the fluorescent imaging technology. The use of "microdoses" (approximately 0.1 mg) of indocyanine green has been trialed and shown promise in some patients. This study aims to do an in depth study utilizing the Cancer goggle systems fluorescent imaging system to determine the correct dose needed to isolate the biliary system without over fluorescing surrounding structures. This dosing study could additionally serve as a pilot study for follow on research using indocyanine green and fluorescent imaging in hepatobiliary surgery.

Conditions

• Hepatobiliary Surgery

Interventions

Type	Name	Description
DEVICE	Cancer goggle system	-The cancer goggle system is being used as a non-significant risk device

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-05-13
• Last updated: 2022-01-24

Regulatory

• FDA-regulated device study