NCT02235779Unknown不适用
DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease
研究概览
简要总结
Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies done via bronchoscopy in the investigation of interstitial lung disease in comparison with videothoracoscopy-assisted surgical lung biopsy.
详细描述
See above
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
- •Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is planned for diagnostic investigation.
排除标准
- •Aged less than 18 y.o.
- •Pregnancy
- •Known coagulatoin disorder or blood dyscrasia
- •Aaking antiplatelet agents other than aspirin or therapeutic anticoagulants drugs that cannot be safely discontinued to undergo lung biopsy
- •Arterial oxgen pressure less than 60 mmHg on more than 2 liters per minute oxygen
- •Known pulmonary hypertension defined as systolic PAP above 40 mmHg on echocardiography
- •Unable to provide informed consent
结局指标
主要结局
Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease
时间窗: After biopsy (up to 24 months)
Number of cryobiopsy specimens from which a specific diagnosis of interstitial lung disease can be ascertained, as assessed by a two different pathologists blinded to the known final diagnosis.
次要结局
- Complication rate of transbronchial cryobiopsy procedure(Per-procedure and up to 24 hours after)
- Size of cryobiopsy specimen(After biopsy (up to 24months))
- Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen(After biopsy (up to 24 months))
- Inter-observer agreement for cryobiopsy specimens(After biopsy (up to 24 months))
- Quality of cyrobiopsy specimens(After biopsy (up to 24 months))
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical VentilationLung DiseasesInterstitial DiseaseNCT02611297Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau15
Unknown
不适用
Diagnostic Value of Transbronchial Lung CryobiopsyInterstitial Lung DiseaseNCT02579304KU Leuven20
Unknown
不适用
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung DiseasesDiffuse Parenchymal Lung DiseasesNCT03704233Guangzhou Institute of Respiratory Disease350
Unknown
不适用
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral NoduleDiagnosisComplication RateNCT04661956ShiYue Li300
尚未招募
不适用
A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary FibrosisTransbronchial CryobiopsyPulmonary FibrosisNCT06275295China-Japan Friendship Hospital300