A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 8
- 主要终点
- Time from first outpatient appointment to decision to treat
研究概览
简要总结
In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. The investigators wish to determine whether using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment decision, a reduction in the total number of scans and investigative operations, fewer outpatient attendances and a reduction in healthcare costs.
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
- •Consecutive patients suspected of lung cancer on CT scan
- •Written informed consent
- •Able to tolerate bronchoscopy and thoracic surgery
排除标准
- •Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial
- •Any disorder making reliable informed consent impossible
- •Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion
结局指标
主要结局
Time from first outpatient appointment to decision to treat
时间窗: 1 - 3 months
次要结局
- The healthcare costs for diagnosing and staging lung cancer(End of study)
- The number of futile thoracotomies(1 - 3 years)
- The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer(1 - 3 months)
- The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan(1 - 3 months)
- The time from first outpatient appointment to treatment(1 - 3 months)
研究者
Sam Janes
Reader in Respiratory Medicine
University College London Hospitals