NCT06251687招募中不适用
Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Prospective Study
China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the diagnostic performance of transbronchial cryobiopsy（TBLC）
研究概览
简要总结
The goal of this clinical study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC）in progressive pulmonary fibrosis. The main question it aims to answer are: • Determine the prognosis, health economics, and therapeutic strategy changes of patients with TBLC retrograde malleable pulmonary fibrosis. Participants will be randomly divided into two groups, and received TBLB or TBLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.
排除标准
- •Patients with platelet counts below 50,000×109/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC
结局指标
主要结局
the diagnostic performance of transbronchial cryobiopsy（TBLC）
时间窗: 1 month after transbronchial cryobiopsy
the sensitivity and specificity of transbronchial cryobiopsy（TBLC）in suspected progressive pulmonary fibrosis
次要结局
- the safety of transbronchial cryobiopsy（TBLC)(7 days and 1 month after transbronchial cryobiopsy)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital
研究点 (1)
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