Phase 2
Completed N=60
Low Dose ICG for Biliary Tract and Tumor Imaging
Source: ClinicalTrials.gov NCT04942665 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio — 2.7; 0.7 ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio |
2.7; 0.7 | — |
| SECONDARY Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light |
3.4; 3.1 | — |
| SECONDARY Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio |
6.1; 2.7 | — |
| SECONDARY Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts) |
3.6; 2.8; 3.6; 3.5; 3.6; 3.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04942665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.