Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Detected pelvic and paraaortic sentinel lymph node numbers
研究概览
简要总结
The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.
详细描述
Endometrial tracer injection will be performed by cervical or transcervical endometrial methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
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
- •Endometrial Cancer Patients
- •Suitable patients for surgical staging
排除标准
- •Patients who cannot undergo cervical or transcervical endometrial injection
- •Pathology did not confirm endometrial cancer
- •Sarcoma of the uterine corpus
- •If a 90-day follow-up was not feasible
研究组 & 干预措施
Transcervical endometrial injection arm
Tracer injection performed by a transcervical catheter in endometrial cancer patients.
干预措施: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles (Procedure)
Cervical injection arm
Tracer injection was administered via the cervical route in endometrial cancer patients.
干预措施: Cervical injection of technetium 99 m-labeled human albumin colloid particles (Procedure)
结局指标
主要结局
Detected pelvic and paraaortic sentinel lymph node numbers
时间窗: Postoperative 30 days
Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)
次要结局
- Numbers adverse events(Postoperative 90 days)
研究者
Şener Gezer
Principal Investigator
Kocaeli University