Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Adverse events related to use of indocyanine green (ICG)
研究概览
简要总结
The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-89
- •Planned laparoscopic cholecystectomy
排除标准
- •Inability to provide informed consent
- •Allergy to ICG, iodine, and/or shellfish
- •Lactating
研究组 & 干预措施
NIRF-C and IOC
Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.
干预措施: Indocyanine Green (ICG) (Drug)
NIRF-C and IOC
Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.
干预措施: Near Infrared Fluorescence Cholangiography (NIRF-C) (Device)
结局指标
主要结局
Adverse events related to use of indocyanine green (ICG)
时间窗: Injection to 2 wk follow-up
Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed.
Procedure time
时间窗: Intraoperative
The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
Anatomic identification with NIRF-C and IOC
时间窗: Intraoperative
Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality.
次要结局
未报告次要终点
研究者
Narula, Vimal K, MD
Associate Professor
Ohio State University