Sentinel Lymph Node in Early Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of performing the sentinel node technique (Detection rate)
研究概览
简要总结
This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
详细描述
The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer.
With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
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
- •Informed consent signed previously to performing any procedure related to the clinical trial.
- •Patients who are women 18 years of age or older at the moment of the randomization.
- •Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed .
排除标准
- •Informed consent not obtained or withdraw.
- •Benign result in extemporaneous study
- •Previous history of vascular surgery in the aorta, cava or pelvic vessels
- •Previous pelvic or para-aortic lymphadenectomy
- •Previous lymphoma
- •Previous abdomino-pelvic tumor
- •Previous allergic reaction to indocyanine green
- •Pregnancy / lactation
- •Severe adherent syndrome
研究组 & 干预措施
Patients with ovarian cancer
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection
干预措施: sentinel node technique (Other)
结局指标
主要结局
Feasibility of performing the sentinel node technique (Detection rate)
时间窗: Intraoperative (day 0)
The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
次要结局
- Number of detected sentinel nodes(After anatomopathological study (day 30))
- Rate of realization of the technique(After anatomopathological study (day 30))
- Anatomical location of the sentinel node(s)(After anatomopathological study (day 30))
- Characterization of the sample by collecting tumor markers(Day 0)
- Characterization of the sample by collecting baseline characteristics(Screening (day 0))
- Characterization of the sample by collecting intraoperative findings(Day 0)
- Characterization of the sample by collecting surgical procedures(Day 0)