Pelvic Sentinel Node According to SHREC-trial for the Application of the 2021 European Recommendations for Lymph Node Staging Strategy in Endometrial Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bilateral node detection rates
研究概览
简要总结
According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.
Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling.
The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.
详细描述
Introduction:
According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.
The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.
Patients and Method:
All patients presenting with early FIGO stage and low, intermediate, high intermediate or high risk endometrial carcinoma will be prospectively enrolled.
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
- •Letter of non objection Endometrial carcinoma Stage FIGO I-II whatever the histological subtype. ESGO-ESMO-ESTRO 2021 risk classification : low, intermediate, high intermediate, high Laparoscopic approach.
排除标准
- •Participation refusal Medical contraindication to laparoscopic approach. Stage FIGO > II Suspected Indocyanine Green allergy
结局指标
主要结局
Bilateral node detection rates
时间窗: Day 0 (during surgery)
target = 70% to 90%
次要结局
- Salvage operations in case of GS failure(Day 0 (during surgery))
- sentinel nodes(Day 0 (during surgery))
- adverse events(Day 30)
- factors for detection failure(Day 0 (during surgery))