NCT04302714已完成不适用
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a Multicenter Prospective Randomized Study
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2017年3月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Detection rate
研究概览
简要总结
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a multicenter prospective randomized study
详细描述
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from the patient;
- •Histological diagnosis of endometrial cancer (including type I and II EC);
- •Early stage (FIGO stage < 4);
- •Age older than 18 years.
排除标准
- •Preoperative diagnosis of extra-uterine disease;
- •Preoperative suspicious of gross positive nodes;
- •Execution of neoadjuvant chemotherapy;
- •Contraindication to upfront general anesthesia and or mini-invasive surgery;
- •Systemic infections ongoing;
- •Pregnancy ongoing.
结局指标
主要结局
Detection rate
时间窗: 30 month
assessment of Detection rate in the para-aortic area
次要结局
- Intraoperative complications(30 month)
- Detection rate(30 month)
- Operative time(30 month)
- Postoperative complications(30 month)
研究者
研究点 (2)
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