SEntine Lymph Node in earLY Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Detection rate
研究概览
简要总结
The present study aims at investigating the feasibility, the detection rate and the negative predictive value of sentinel node in predicting the presence or absence of lymph node metastasis in ovarian cancer patients
详细描述
Patients with early stage ovarian cancer have a good prognosis. However, nearly 15% of the initially diagnosed as early stage ovarian cancers, will be upstaged after an appropriate surgical staging due to lymphatic metastasis, despite of preoperative radiological data. Therefore, complete pelvic and para-aortic lymphadenectomy in these patients represents a crucial procedure. On the other hand, nodal dissection may be associated with threatening intra- and post-operative complications.
If feasible and accurate, the sentinel lymph node procedure could be a modality to avoid unnecessary radical lymphadenectomy without missing important information on nodal status.
With the present study we aim at exploring the role of sentinel node dissection in early ovarian cancer patients.
Patients with ovarian cancer macroscopically limited to the ovary (early ovarian cancer) will receive injection of a tracer (patent blue or indocyanine green) which have already been proven safe and extremely effective in several other gynecologic and non-gynecologic malignancies. Then the retroperitoneal spaces will be opened as for a standard lymphadenectomy procedure and the lymph node marked with the tracer will be identified. After dissection of the sentinel node, lymphadenectomy will be completed according to current guidelines.
Operative data, pathological findings and accuracy of sentinel node in predicting nodal status will be registered.
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 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Epithelial ovarian cancer
- •Early stage disease limited to the ovary
排除标准
- •Evidence of extraovarian disease
- •Allergy to the materials used
结局指标
主要结局
Detection rate
时间窗: 24 months
The rate of patients in whom the sentinel node is detected
Number of participants with procedure-related adverse events
时间窗: 6 months
The number of patients with procedure-related adverse events as assessed by CTCAE v4.0
次要结局
- Negative predictive value(24 months)
研究者
SCAMBIA GIOVANNI
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
