NCT02825355已完成不适用
Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 512
- 试验地点
- 3
- 主要终点
- Incidence of lymphedema
研究概览
简要总结
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size < 2 cm
- •Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, > 50% myometrial invasion
排除标准
- •Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
- •Women included in other studies affecting outcome-measures of the present study
结局指标
主要结局
Incidence of lymphedema
时间窗: 3 years
Incidence of lymphedema will be assessed using patient reported outcome measures.
Severity of lymphedema
时间窗: 3 years
Severity of lymphedema will be assessed using patient reported outcome measures.
次要结局
- Detection rate of sentinel lymph node(2 years)
- Mapping of SLN in different types of lymph node stations(2 years)
研究者
Sara Sponholtz
MD
University of Southern Denmark
研究点 (3)
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