A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neck Dissection
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Recognize injury intra-operatively
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This phase I trial studies how well indocyanine green lymphangiography works in identifying thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence imaging with indocyanine green may help recognize and prevent injury to thoracic duct during neck surgery.
Detailed Description
PRIMARY OBJECTIVES: I. Feasibility and optimization of thoracic duct identification using indocyanine green (ICG) lymphangiography. II. To explore specifically how identifying the thoracic duct (TD) will prevent injury intra-operatively. III. To understand if a TD injury can be recognized by leakage of fluorescent chyle into the operating field. OUTLINE: Participants receive indocyanine green solution subcutaneously (SC) and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery. After completion of study treatment, participants are followed up for up to 1 year.
Investigators
John Phay, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
Inclusion Criteria
- •Healthy adult patients who are undergoing LEFT modified radical or selective (including zone IV) lymph node dissection for any indication; this includes patients who have had prior neck surgery
Exclusion Criteria
- •Children, minors, pregnant women, women who are breast feeding, institutionalized patients
- •Known prior allergic reaction to ICG or allergy to iodine
- •Patients with excessively high anesthesia risks who cannot tolerate the extra time under general anesthesia needed to perform this study; the surgeon and anesthesiologist will determine this pre-operatively
Outcomes
Primary Outcomes
Recognize injury intra-operatively
Time Frame: Up to 1 year
Will be mostly qualitative data collection on how the injury was identified and in what percent.
Prevent injury to the TD
Time Frame: Up to 1 year
Percentage of patients with TD injury will be calculated and compared to contemporary rates of injury.
Identify thoracic duct (TD) using indocyanine green (ICG)
Time Frame: Up to 1 year
We will determine in how many patients the thoracic duct is identified by white light visualization and by ICG fluorescence. The collected data will be primarily qualitative as determined by the surgeon.