Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Diagnostic yield of bronchoscopy
研究概览
简要总结
Bronchoscopy of non visible lesions in the lung, have a low diagnostic yield. The use of endoscopic ultrasound might increase the diagnostic yield. This prospective study randomises between bronchoscopy with the use of a ultrasound miniprobe and bronchoscopy without the use of a miniprobe in clinical practice at Haukeland University Hospital.
The study hypothesis:
The use of the ultrasound miniprobe will increase the diagnostic yield of bronchoscopy in non visible lesions.
详细描述
Bronchoscopy is usually the primary investigation of lesions in the lung. X-ray fluorescence guides the sampling with brushing, biopsy or trans bronchial needle aspiration (TBNA) if the lesion not is visible. Ct guided trans-thoracic sampling will be performed if a the sample is non representative. This will delay the diagnosis, and trans-thoracic sampling has a higher risk of pneumothorax. The use of a ultrasound miniprobe might increase the diagnostic yield of bronchoscopy in non visible lesions. The ultrasound probe in a guide sheath is advanced to the lesion with use of X-ray fluorescence. When the lesion is visualised the miniprobe is removed and sampling is performed with TBNA, biopsy and brushing through the guide sheath. If rapid on site cytoevaluation is negative, new TBNA is performed. Previous trials have shown a diagnostic yield without ultrasound between 40-50% and with ultrasound between 60-80%. The studies with ultrasound have been performed by "super specialists". This study will evaluate bronchoscopy with the use of ultrasound miniprobe in clinical practice without "super specialists". It is a prospective randomised trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with lesions suspicious of malignancy in the lung.
排除标准
- •Patients with lesions assumed to be visible by bronchoscopy.
- •Later proven visible lesion by bronchoscopy.
- •Patients not able to be investigated by bronchoscopy.
结局指标
主要结局
Diagnostic yield of bronchoscopy
时间窗: 6 months
次要结局
未报告次要终点
