Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tumor invasion
研究概览
简要总结
In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient's age is 18 or above
- •Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms.
- •Patient able to understand,read and sign informed consent.
- •Patient is not participating in other medical trials at present or in the past 30 days
排除标准
- •Age under 18 years
- •Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma
- •Subjects which their biopsy in the pre operating process will include high risk cell types:
- •Grade 3 endometrioid adenocarcinoma,
- •clear cell carcinoma
- •papillary serous carcinoma
- •carcinosarcoma
研究组 & 干预措施
Endometrial carcinoma patient
干预措施: Intraoperative ultrasound (Device)
结局指标
主要结局
Tumor invasion
时间窗: Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)
Tumor invasion (in millimeters and in percentage of myometrial size) as assessed by ultrasound in comparison to macroscopic assesment during surgery and to final pathological report)
次要结局
未报告次要终点
研究者
Ido Feferkorn
MD
Carmel Medical Center