Using cryobiopsy to diagnose progressive pulmonary fibrosis
Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Prospective Study
This study is testing a new lung biopsy method called cryobiopsy to see if it can diagnose progressive pulmonary fibrosis better and safer than the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06251687 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the diagnostic effectiveness and safety of transbronchial cryobiopsy (TBLC) in patients with progressive pulmonary fibrosis (PPF). Participants will be randomly assigned to receive either TBLC or traditional transbronchial lung biopsy (TBLB) to compare outcomes. The study will also assess the prognosis, health economics, and potential changes in therapeutic strategies for patients diagnosed with PPF using TBLC. The findings could provide valuable insights into the best diagnostic approaches for this condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with progressive pulmonary fibrosis and specific lung function criteria.
Not a fit: Patients with severe coagulopathy or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy and treatment strategies for patients with progressive pulmonary fibrosis.
How similar studies have performed: While there is ongoing research in the field of pulmonary fibrosis diagnostics, the specific application of transbronchial cryobiopsy in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.