NCT00960271已完成不适用
Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 363 人开始时间: 2008年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- number of mediastinoscopy avoided
研究概览
简要总结
This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients over 18
- •non small cell lung cancer histologically or cytologically proved
- •Clinical Stage IIIA
- •anatomically and functionally resectable
排除标准
- •uncorrected bleeding disorders
- •absence of lymphadenopathy superior to 1cm in small axis at CT scan
- •contraindication to bronchoscopy
- •extrathoracic or intrathoracic metastasis
- •respiratory function tests not compatible with curative resection of lung cancer
结局指标
主要结局
number of mediastinoscopy avoided
时间窗: 24h
次要结局
未报告次要终点
研究者
研究点 (1)
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