Fluorescence Imaging in Hepatobiliary Surgery

Evaluation of Fluorescence Imaging in Hepatobiliary Surgery

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03946761

Enrollment

Registered

2019-05-13

Start date

2021-12-31

Completion date

2022-12-31

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatobiliary Surgery

Brief 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.

Interventions

DEVICECancer goggle system

-The cancer goggle system is being used as a non-significant risk device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Planned open liver resection or ablation. * At least 18 years of age. * Able to understand and willing to sign a written informed consent document.

Exclusion criteria

-History of allergic reactions attributed to ICG, iodine, iodine dye, or other agents used in the study.

Design outcomes

Primary

Measure	Time frame
The minimum dose of the ICG that causes initial fluorescence of the liver	Through completion of surgery for all participants enrolled (estimated to take 1 year)

Secondary

Measure	Time frame
The visible status of the bile ducts and/or bile leaks from the cut surface of the liver at ICG doses administered in our dosing regimen	Through completion of surgery for all participants enrolled (estimated to take 1 year)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026