Sentinel Lymph Node Assessment In Ovarian Cancer - Turkish Gynecologic Oncology Group Study (TRSGO-SLN-005)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.
详细描述
Systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. However, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. In the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. For preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease.
Aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. Pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. Than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.
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
- •Patients with Early stage ovarian cancer
排除标准
- •Patient who had been administrated chemotherapy prior to surgery
- •Patients who had diagnosed with malignancy other than ovarian cancer.
- •Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery.
- •Patients who have allergy for the tracers.
结局指标
主要结局
Adverse events
时间窗: 12 months
Adverse events related with sentinel lymph node procedure in ovarian cancer
Sentinel lymph node localization
时间窗: 12 months
Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.
Sentinel lymph node technique accuracy in ovarian cancer
时间窗: 12 months
Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis
Sentinel lymph node detection rate
时间窗: 12 months
Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
PPV and NPV of sentinel lymph node procedure in ovarian cancer
时间窗: 12 months
Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.
次要结局
- Tracer comparisons(12 months)
- Assessment of the sentinel tecniques(12 months)
研究者
Ozguc Takmaz
MD,Assistant Professor
Acibadem University