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临床试验/NCT02070640
NCT02070640已完成不适用

Near Infrared Fluorescence Cholangiography During Cholecystectomy

Ohio State University1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
1
主要终点
Complications Related to 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). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

详细描述

This study is designed to determine the clinical utility of intravenous indocyanine green (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. Testing will be done during an abdominal surgery which requires gallbladder removal. Subjects will be recruited during consult for their surgical procedure. The study itself will take an estimated 5 minutes during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be given. Following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (IOC), which is standard of care. Subject post-operative recovery will be monitored for the duration of their hospital stay. Adverse events will be monitored at the patient's routine follow up visit.

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

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
  • Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
  • Lactating

研究组 & 干预措施

NIRF-C

Experimental

Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera.

干预措施: Injection of indocyanine green (ICG) (Drug)

NIRF-C

Experimental

Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera.

干预措施: Near Infrared Cholangiography Fluorescence (NIRF-C) (Device)

结局指标

主要结局

Complications Related to ICG

时间窗: From time of injection to 1st post-op follow-up

A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.

次要结局

  • Incidence of Anatomic Identification With NIRF-C(Intraoperative)
  • Time to Complete NIRF-C and IOC(Intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Narula, Vimal K, MD

Associate Professor

Ohio State University

研究点 (1)

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