Learning Curve for the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy and the Role of Standardized Training in It
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Obtain pathologic quality assessment of specimens
研究概览
简要总结
The aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (TBLC) operating physicians, and to assess the role of standardized training in TBLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥18 years
- •suspected ILD.
- •≤3 months since HRCT
- •Forced vital capacity (FVC) ≥50% of predicted value
- •Diffused lung carbon monoxide (DLCO) ≥35% predicted value
- •Echocardiography ≤ 12 months
- •Estimated pulmonary artery systolic pressure ≤40 mmHg
- •Body mass index (BMI) ≤35 kg/m2
- •Patient consent for experimentation
排除标准
- •Patients with platelet counts less than 50 × 109/L or prothrombin time international normalized ratio (INR) higher than 1.5
- •Patients refused to participate in the experiment
结局指标
主要结局
Obtain pathologic quality assessment of specimens
时间窗: 1 month
The quality of TBLC sampling specimens was scored by two professional pathologists on a specialized pathology scale.
histopathological pattern diagnosis rate
时间窗: 1 month
Diagnosis of histopathological patterns was performed by two specialized pathologists to determine a consistent diagnostic rate.
diagnostic rate of multidisciplinary discussions
时间窗: 1 month
Diagnostic rates based on composite TBLC, BAL, clinical and imaging data in a multidisciplinary discussion by clinical experts
次要结局
- Occurrence of short-term adverse events(24 hours or 7 days)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital