The Safety and Diagnostic Efficacy of Cone Beam CT Guided Transbronchial Cryobiopsy for ILD Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- safety profile of procedure
研究概览
简要总结
Interstitial lung diseases (ILD) are common in clinical practices and need multidisciplinary assessment of clinical presentations, radiological and histological features. Transbronchial cryobiopsy (TBCB) is one of the most important invasive procedures for ILD when a confident diagnosis cannot be made by clinical and radiological assessment. TBCB could lead to higher incidence of risks. The pneumothorax and severe bleeding seemed to be more common in patients with TBCB.
Cone-beam computed tomography (CBCT) could provide 3-dimensinal (3D) CT images which were close to the image qualities of conventional CT. The probe-to-pleura relationship could be accurately established by the 3D CT scan and the cryobiopsy safety profile might be improved under the guidance of CBCT. In this study, we conducted a prospective study to observe the safety and diagnostic efficacy of CBCT guided TBCB for the DPLD patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35%
排除标准
- •acute exacerbation within one month, bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients with pulmonary hypertension, respiratory failure, liver, kidney disfunction, and cardiac insufficiency, PLT less than 50 x 109/L
结局指标
主要结局
safety profile of procedure
时间窗: 30 days
pneumothorax, bleeding severity, post-bronchoscopy fever, acute exacerbation of ILD, procedure related death.
次要结局
- diagnostic efficacy(30 days)
研究者
Dai Huaping
vice Director of Respiratory disease Center
China-Japan Friendship Hospital