Fluorescence Imaging in Hepatobiliary Surgery

NCT03946761 | Withdrawn DMC FDA Device

• 1 other identifier: 201904180
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatobiliary Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Cancer goggle system

EXPERIMENTAL

* 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

Interventions

Cancer goggle system DEVICE

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

Cancer goggle system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

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

Study Officials

• Chet Hammill, M.D., FACS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 13, 2019
• Study Start: December 31, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share