Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio
Study Overview
Brief Summary
Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG can be administered on the same day of surgery in order to augment real-time intraoperative visualization, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.
Detailed Description
The investigators have a series of surgical cases in which the investigators have been able to achieve excellent intraoperative biliary visualization with a greatly decreased (50-200 fold lower) dose of ICG than the previously published dose. Furthermore, this decreased dose was visible in about 15-20 minutes from the time of injection with low liver background fluorescence, a significant improvement that would make its utilization in the operating room more practical. The investigators hypothesize that a lower dose will: 1) allow adequate visualization of the extrahepatic biliary tree, including the cystic, common hepatic, and common bile ducts. Confirmation of hypotheses would mean that a lower dose of ICG can be administered on the same day of surgery in order to augment real-time intraoperative localization of the extrahepatic biliary tree, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.
The investigators intend to test our hypothesis with the following specific aims:
Aim 1: To compare the efficacy and utility of a low dose ICG (0.05 mg) protocol with a previously published dose (2.5 mg) in imaging the extrahepatic biliary tract.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Masking Description
To mask the investigator randomization will be done with envelopes for this study and the dose given to the patient prior to surgery with the investigator not being aware of the amount given.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing standard of care laparoscopic hepatic or biliary operations or Patients undergoing standard of care laparoscopic resection for hepatic tumors: hepatocellular carcinoma or metastatic tumor
Exclusion Criteria
- •Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes and Pregnant and/or lactating patients.
Arms & Interventions
Low Dose
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Intervention: Indocyanine green (Drug)
Low Dose
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Intervention: PINPOINT Endoscopic Fluorescence (Device)
Standard Dose
Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.
Intervention: Indocyanine green (Drug)
Standard Dose
Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.
Intervention: PINPOINT Endoscopic Fluorescence (Device)
Outcomes
Primary Outcomes
Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio
Time Frame: intraoperative, average of 2 hours
Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver
Secondary Outcomes
- Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)(intraoperative, average of 2 hours)
- Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio(intraoperative, average of 2 hours)
- Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light(intraoperative, average of 2 hours)