Pulmonary Fibrosis, Transbronchial Cryobiopsy
Conditions
Brief summary
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.
Interventions
PROCEDURETransbronchial Cryobiopsy，TBLC
Transbronchial lung cryobiopsy (TBLC) is a novel technique that has proved its diagnostic value in various diffuse parenchymal lung diseases
PROCEDURETransbronchial Lung Biopsy，TBLB
Transbronchial lung biopsy (TBLB) is a relatively safe technique routinely employed by pulmonologists for the diagnosis of diffuse parenchymal lung disease
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the diagnostic performance of transbronchial cryobiopsy（TBLC） | 1 month after transbronchial cryobiopsy | the sensitivity and specificity of transbronchial cryobiopsy（TBLC）in suspected progressive pulmonary fibrosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the safety of transbronchial cryobiopsy（TBLC) | 7 days and 1 month after transbronchial cryobiopsy | The occurence of short-term procedure-related complications, including Bleeding, pneumothorax, death, etc |
Countries
China
Outcome results
None listed