Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •accepted informed consent
- •preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
- •patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)
排除标准
- •rejected informed consent
- •patients not fit to surgery (according to the general health condition and the clinical tumor stage)
- •pregnant women
结局指标
主要结局
Overall survival
时间窗: 5 years
Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.
Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy
时间窗: 5 years
Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins
时间窗: 5 years
Disease-free survival
时间窗: 5 years
Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.
次要结局
未报告次要终点
研究者
Nicola Malagutti
Principal Investigator
University Hospital of Ferrara