A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Recognize injury intra-operatively
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recognize injury intra-operatively
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
John Phay, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center