Low Dose ICG for Biliary Tract and Tumor Imaging

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 15, 2021

Primary Completion Date

September 15, 2022

Study Completion Date

April 1, 2023

Conditions
CholecystitisHepatocellular CarcinomaLiver Metastases
Interventions
DRUG

Indocyanine green

Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

DEVICE

PINPOINT Endoscopic Fluorescence

The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.

Trial Locations (1)

32610

University of Florida Health Shands, Gainesville

All Listed Sponsors
collaborator

Society of University Surgeons

OTHER

lead

University of Florida

OTHER

NCT04942665 - Low Dose ICG for Biliary Tract and Tumor Imaging | Biotech Hunter | Biotech Hunter