Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

Neck Dissection Clinical Trial

Official title:

A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532581
• Other study ID #: OSU-17368
• Secondary ID: NCI-2018-00390
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: March 7, 2023

Study information

• Verified date: January 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neck Dissection
• Radical Lymph Node Dissection

Intervention

Other:
• Indocyanine Green Solution
Given Subcutaneous injection

Procedure:
• Lymphangiography
Undergo lymphangiography

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify thoracic duct (TD) using indocyanine green (ICG)	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.	Up to 1 year
Primary	Prevent injury to the TD	Percentage of patients with TD injury will be calculated and compared to contemporary rates of injury.	Up to 1 year
Primary	Recognize injury intra-operatively	Will be mostly qualitative data collection on how the injury was identified and in what percent.	Up to 1 year

External Links

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