Diagnosis of Peripheral Pulmonary Lesions: Benefit of Endoscopic Sample Under Fluoroscopic Controle After Non Contributive Endoscopic Samples Guided by Radial EBUS-miniprobe.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Percentage Definitive anatomopathological diagnosis
研究概览
简要总结
There is an interest in characterazing asymptomatic peripheral lung lesions beacause they could be an early form of neoplasm.
These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique.
The trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes can be used to collect tissue sample.
When no diagnosis is made with this technique, the attitude can be discussed between different option: follow up versus an other sampling technique (transthoracic ponction, surgery,...).
In this study the investigators will study the interest of a sampling guided by fluoroscopy after a negative sampling guided by radial echo-endoscopic miniprobe.
People presenting with a peripheral lung lesion, invisible with a classical endoscopy, will be included after they sign an informed consent. The bronchoscopy will be executed after a local anesthesia and if there are no visible endobronchial lesions, the radial EBUS mini-probe will be used.
If these samples give an anatomopathologic diagnosis consistent with the clinical context, no other exam will be proposed.
If there isn't a diagnosis after this first exam, a second exam will be proposed to the participants including an histologic smear, a trans bronchial biopsy and a fine needle aspiration under fluoroscopic guidance.
详细描述
Because of the more frequent use of thoracic imaging by ct-scan, there are a growing number of asymptomatic peripheral lung lesions that are revealed.
As they could be a be an early form of pulmonary neoplasm, it is important for the patient that a definitive diagnosis is made.
These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique.
The first guided technique was the biopsy under fluoroscopic control. During the last decade, several other technique have been developed.
Among them is the trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes. This technique has the advantage of needing no exposition to ionizing radiation and lower the risk of pneumothorax, comparing with transthoracic ponction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 presenting a peripheral lung lesion having given their approval
排除标准
- •Lung lesion who according to ct Scan has a greater diameter lesser than 10 mm
- •Ground glass lesion
- •Lesion that are suspected to be a bronchopneumonia
- •Contra-indication for endoscopic exam ( uncontrolled hypoxia, hypercapnia, sympotmatic bronchial hyperreactivity, recent myocardial infarction, heart failure)
- •contra-indication for a transbronchial biopsy ( coagulapathy iatrogenic or not, recent uptake of anitaggregant medicines)
结局指标
主要结局
Percentage Definitive anatomopathological diagnosis
时间窗: 1 week
Percentage Definitive anatomopathological diagnosis obtained via the pathological exam of microscopic evaluation, immunostaining and/ or molecular analysis)
次要结局
未报告次要终点
研究者
Marie Bruyneel
Principal investigator, pneumology
Centre Hospitalier Universitaire Saint Pierre