Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- histopathological agreement
研究概览
简要总结
Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics
详细描述
Before one is able to state that TBLC is a technique that is an alternative for VATS biopsy, the diagnostic value of TBLC should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. For this purpose direct comparison between VATS biopsy and TBLC is unavoidable. By including TBLC in the work-up of patients with DILD in which histopathological assessment is indicated (as proposed by MDD), we want to assess 3 major points of concern.
Agreement for the histopathological diagnosis between VATS biopsy and TBLC. Value of TBLC in the specific diagnosis in ILD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Case of DILD presented at the MDD
- •Referral for VATS biopsy as advised by MDD.
- •Informed consent available
- •Age > 18
- •FVC > 50%pred
- •DLCO > 40%pred
- •PaO2 > 65 mmHg, pCO2 < 45 mmHg
- •No exclusion criteria
排除标准
- •- Age > 75
- •PAPS >40mmHg as measured on transthoracic cardiac ultrasound
- •Platelet count <100000/µl
- •INR > 1.4
- •Diffuse bullous lung disease
- •Active anti-platelet or anticoagulant treatment
- •Active heart failure or unstable coronary heart disease
- •Patients unfit for VATS under general anaesthesia as assessed by the surgeon and/or anesthesiologist
结局指标
主要结局
histopathological agreement
时间窗: 2 years
Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)
次要结局
- procedural safety : bleeding(periprocedural 1 hour)
- procedural safety : bleeding (2)(periprocedural 1 hour)
- procedural safety : bleeding (3)(periprocedural 1 hour)
- procedural safety : penumothorax(periprocedural 1 hour)