Fluorescence Imaging in Hepatobiliary Surgery

Sponsor

Washington University School of Medicine (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03946761

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatobiliary Surgery	Device: Cancer goggle system	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Fluorescence Imaging in Hepatobiliary Surgery

Anticipated Study Start Date :

Dec 31, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cancer goggle system The surgical procedure will be performed according to standard practice, with the exception of microdosing of ICG & visualization of biliary/liver anatomy using the cancer goggles system The surgeon will start with a peripherally injected microdose of 0.02 mg of ICG & will inject an additional 0.02mg every 5 minutes until a noticeable fluorescent change in the liver is observed. If a change is not observed after 0.14 mg has been injected then the microdosing regimen will stop. Output video from the cancer goggles will be recorded and saved for post-surgical analysis. Following resection of the liver parenchyma, the portal area and the cut surface of the liver will be analyzed for the identification of bile ducts leaks with or without cancer goggles.	Device: Cancer goggle system -The cancer goggle system is being used as a non-significant risk device

Arm

Intervention/Treatment

Experimental: Cancer goggle system

The surgical procedure will be performed according to standard practice, with the exception of microdosing of ICG & visualization of biliary/liver anatomy using the cancer goggles system The surgeon will start with a peripherally injected microdose of 0.02 mg of ICG & will inject an additional 0.02mg every 5 minutes until a noticeable fluorescent change in the liver is observed. If a change is not observed after 0.14 mg has been injected then the microdosing regimen will stop. Output video from the cancer goggles will be recorded and saved for post-surgical analysis. Following resection of the liver parenchyma, the portal area and the cut surface of the liver will be analyzed for the identification of bile ducts leaks with or without cancer goggles.

Device: Cancer goggle system

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Chet Hammill, M.D., FACS, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT03946761

Other Study ID Numbers:

201904180

First Posted:

May 13, 2019

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jan 24, 2022