NCT00119470已完成2 期
EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage of surgical interventions avoided
研究概览
简要总结
This trial examines the role of EUS-FNA (Oesophageal Endoscopic Ultrasound with Fine Needle Aspiration) as an endoscopic technique for the mediastinal staging of patients with lung cancer.
Patients will be randomized to either conventional surgical technique or EUS-FNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •patients with histological or cytological proof of non small cell lung cancer (NSCLC) or with a high clinical suspicion for lung cancer (but without pathologically confirmed diagnosis from the bronchoscopy or CT guided transthoracal biopsies) in whom the next step is normally a diagnostic or therapeutic surgical intervention
- •no distant metastases after routine clinical work up (PET is optional, not mandatory)
- •provision of a written informed consent
- •recent CT-scan of the thorax (<28 days before randomization date)
- •age 18 years or older
- •clinically fit for surgery
排除标准
- •proof of small cell lung cancer (SCLC) with CWU (bronchoscopy or CT guided transthoracal punction)
- •stage IV NSCLC
- •patients with a solitary pulmonary nodule (thus without enlarged mediastinal lymph nodes on CT and without mediastinal PET hot spots) : these do not require further mediastinal investigation
- •former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
- •other concomitant malignancies
- •reasons for which the patient is unable to swallow the EUS-instrument (e.g. zenker diverticulum, unexplained esophageal stenosis)
- •uncorrected coagulopathy
结局指标
主要结局
Percentage of surgical interventions avoided
次要结局
- Accuracy of EUS-FNA for mediastinal staging of lung cancer
研究者
研究点 (2)
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