The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The accuracy of detecting small liver tumor by ICG fluorescence.
研究概览
简要总结
This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of liver tumors. By correlating the ICG fluorescence patterns with pathologically confirmed tumors , it would be possible to use fluorescence navigation system in helping promoting oncology treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years≤ Age ≤70 years
- •Compling with the diagnosis criteria of hepatic carcinoma.
- •Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled.
- •Preoperative liver function is Child - Pugh grade A or B.
- •The patients are volunteered for the study.
排除标准
- •Patients with mental illness.
- •Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.
- •The patients refused to take part in the study.
- •There are other co-existed malignant tumors.
- •Benign liver diseases.
- •Indocyanine green allergy
研究组 & 干预措施
Indocyanine-Green(ICG) injection group
干预措施: Indocyanine-Green(ICG) (Drug)
结局指标
主要结局
The accuracy of detecting small liver tumor by ICG fluorescence.
时间窗: 3 Days
The tumor which aggregate ICG fluorescence will be resected and dignosed by pathology. The accuracy of detecting small liver tumor by ICG fluorescence will be evaluated.
The accuracy of positive margins of resection detected by ICG fluorescence.
时间窗: 3 Days
The surgery margins will be detected by ICG fluorescence. If there is fluorescence aggregating, we consider the presence of residual tumor in the margin and proven by histological examination.
次要结局
未报告次要终点