NCT02563730Unknown不适用
Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy
研究概览
简要总结
A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IIP suspected on clinical and radiologic grounds
排除标准
- •Age >80y and <18y
- •FVC< 55%, DCO<35%
- •Platelet count <100000/µl
- •acetylsalicylic acid, clopidogrel or equivalent during the last 5 days
- •INR > l,3,
- •elevated PTT (> 40 s)
- •documented pulmonary hypertension PAPS >50mmHg
- •HR-CT highly suspicious for sarcoidosis
研究组 & 干预措施
Lung biopsy
Experimental
assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS
干预措施: Lung biopsy (Procedure)
结局指标
主要结局
Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy
时间窗: two weeks
次要结局
- Influence of the size of the cryoprobe in the primary endpoint(2 weeks)
- Rate of exacerbations after cryobiopsy and after surgical biopsy(6 weeks)
- numer of exacerbations after biopsy(6 weeks)
- Quality of specimen(2 weeks)
- numer of bleeding events(1 day)
- Rate of pneumothoraxes(1 day)
- Size of specimen(2 weeks)
- Contribution of BAL and cryobiopsy to diagnosis(2 weeks)
- Distribution of histological changes in the specimen(2 weeks)
- Comparative group (out of trial) - who are referred for VATS directly ['positive control group'](6 weeks)
研究者
Boeckeler, Michael
MD
University Hospital Tuebingen
研究点 (6)
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