Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03532581|
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neck Dissection Radical Lymph Node Dissection||Other: Indocyanine Green Solution Procedure: Lymphangiography||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection|
|Actual Study Start Date :||April 23, 2018|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||July 30, 2021|
Experimental: Treatment (ICG lymphangiography)
Participants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.
Other: Indocyanine Green Solution
Given Subcutaneous injection
Other Name: Lymphography
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532581
|Contact: Ohio State Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: John Phay 614-293-7171 John.Phay@osumc.edu|
|Principal Investigator: John Phay|
|Principal Investigator:||John Phay, MD||Ohio State University Comprehensive Cancer Center|