Fluorescence Imaging in Hepatobiliary Surgery

Hepatobiliary Surgery Clinical Trial

Official title:

Evaluation of Fluorescence Imaging in Hepatobiliary Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03946761
• Other study ID #: 201904180
• Status: Withdrawn
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatobiliary Surgery

Intervention

Device:
• Cancer goggle system
-The cancer goggle system is being used as a non-significant risk device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine