跳至主要内容
临床试验/NCT03946761
NCT03946761撤回不适用

Evaluation of Fluorescence Imaging in Hepatobiliary Surgery

Washington University School of Medicine0 个研究点开始时间: 2021年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
The minimum dose of the ICG that causes initial fluorescence of the liver

研究概览

简要总结

A current gap in the use indocyanine green fluorescence to isolate the biliary system is the dosing amount necessary to fluoresce the biliary system without "over" fluorescing the liver and gallbladder. Over fluorescing surrounding structures such as the liver and gallbladder saturates the image and makes it impossible to identify biliary leaks or differentiate branches of the common bile duct using fluorescent imaging devices. The over dosing does not affect the standard of care procedure, but eliminates the added benefit of the fluorescent imaging technology. The use of "microdoses" (approximately 0.1 mg) of indocyanine green has been trialed and shown promise in some patients. This study aims to do an in depth study utilizing the Cancer goggle systems fluorescent imaging system to determine the correct dose needed to isolate the biliary system without over fluorescing surrounding structures. This dosing study could additionally serve as a pilot study for follow on research using indocyanine green and fluorescent imaging in hepatobiliary surgery.

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

入选标准

  • Planned open liver resection or ablation.
  • At least 18 years of age.
  • Able to understand and willing to sign a written informed consent document.

排除标准

  • History of allergic reactions attributed to ICG, iodine, iodine dye, or other agents used in the study.

结局指标

主要结局

The minimum dose of the ICG that causes initial fluorescence of the liver

时间窗: Through completion of surgery for all participants enrolled (estimated to take 1 year)

次要结局

  • The visible status of the bile ducts and/or bile leaks from the cut surface of the liver at ICG doses administered in our dosing regimen(Through completion of surgery for all participants enrolled (estimated to take 1 year))

研究者

申办方类型
Other
责任方
Sponsor

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