Cryobiopsy vs. VATS: Efficiency and Safety in the Diagnosis of Interstitial Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Rate of diagnostic cryobiopsies
研究概览
简要总结
The purpose of this study is to assess efficiency and safety of cryobiopsy compared to video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases (ILD). To that end, this non-interventional study prospectively collects data from patients undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to VATS if this procedure is reasonable. The information gained by this study will help to assess the significance of cryobiopsy in contrast to VATS in this particular disease group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Known or newly diagnosed interstitial lung disease (ILD)
- •Indication for lung biopsy for definitive ILD diagnosis
- •Informed Consent provided
排除标准
- •Age < 18 years
- •Inability or contraindication to undergo any form of invasive diagnostic procedure associated with diagnosis of interstitial lung disease
- •Severely restricted CO diffusion capacity (<50%)
- •Pregnancy, lactation
- •Any medical, psychological or other condition restricting the patient's ability to provide informed consent
- •Participation in another clinical trial
结局指标
主要结局
Rate of diagnostic cryobiopsies
时间窗: up to 3 days
For the individual study participant, the result of the cryobiopsy (whether it is diagnostically helpful, i.e. "diagnostic" or not, i.e. "inconclusive") will be documented when it is available, which will be within 3 days. The overall number of diagnostic cryobiopsies will be calculated once the study is complete.
次要结局
- Rate of complications during cryobiopsy(During and up to 48 hours after procedure)
- Rate of complications during VATS(During and up to 10 days after procedure)