Actively Recruiting
Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis: a Multicenter Prospective Study
Led by China-Japan Friendship Hospital · Updated on 2025-02-10
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy (TBLC) in people with progressive pulmonary fibrosis. The study aims to understand patient prognosis, health economic impacts, and how therapeutic strategies may change following TBLC. Participants diagnosed with progressive pulmonary fibrosis will be randomly divided into two groups to receive either transbronchial lung biopsy (TBLB) or TBLC. The study compares two procedures: transbronchial cryobiopsy, a newer technique used to diagnose various diffuse lung diseases, and transbronchial lung biopsy, a more commonly used and relatively safe diagnostic method. These procedures will be performed to assess their diagnostic value and safety in this patient population. Participants are assigned randomly to one of these two biopsy methods. During the study, participants will be monitored for diagnostic performance one month after biopsy. Safety assessments will be conducted at seven days and one month after the procedure. Researchers will collect data on lung function, imaging, and clinical status to evaluate outcomes. The study will continue until the end of 2026, with detailed follow-up to measure the impact of each biopsy technique on diagnosis and patient care.
CONDITIONS
Brief Title
Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with progressive pulmonary fibrosis (PPF)
- Age 18 years or older
- Diagnosis of unclassified interstitial lung disease (ILD)
- High-resolution computed tomography (HRCT) performed within 3 months
- Forced vital capacity (FVC) at least 50% of predicted
- Pulmonary carbon monoxide diffusion (DLCO) at least 35% of predicted
- Echocardiography performed within 12 months
- Estimated pulmonary systolic blood pressure 40 mmHg or less
- Body mass index (BMI) 35 kg/m2 or less
You will not qualify if you...
- Platelet count below 50,000 x 10⁹/L
- International Normalized Ratio (INR) of prothrombin time above 1.5
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments including lung function and imaging
Duration - 1 day
Participants undergo either transbronchial cryobiopsy (TBLC) or transbronchial lung biopsy (TBLB) to diagnose progressive pulmonary fibrosis.
1 procedure visit (in-person)
Duration - 1 month
Participants are monitored for diagnostic performance and safety after biopsy.
Visits at 7 days and 1 month post-biopsy for safety and diagnostic outcome assessments
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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