Clinical trial NCT04942665: Low Dose ICG for Biliary Tract and Tumor Imaging
Official title: Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholecystitis
Hepatocellular Carcinoma
Liver Metastases
Keywords: Biliary Tract
Indocyanine Green (ICG)
Tumors
Near-infrared Fluorescence
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Society of University Surgeons
First posted: 2021-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio
timeFrame: intraoperative, average of 2 hours
Secondary outcomes:
measure: Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light
timeFrame: intraoperative, average of 2 hours
measure: Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio
timeFrame: intraoperative, average of 2 hours
measure: Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)
timeFrame: intraoperative, average of 2 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Health Shands
state: Florida
Study officials:
affiliation: University of Florida
name: Ali Zarrinpar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: