Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

Not Applicable

Recruiting

• Conditions: Pulmonary Fibrosis; Transbronchial Cryobiopsy
• Interventions: Procedure: Transbronchial Lung Biopsy，TBLB; Procedure: Transbronchial Cryobiopsy，TBLC

• Registration Number: NCT06251687
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transbronchial Lung Biopsy (TBLB)	Transbronchial Lung Biopsy，TBLB	Transbronchial lung biopsy (TBLB) is a relatively safe technique routinely employed by pulmonologists for the diagnosis of diffuse parenchymal lung disease
Transbronchial Cryobiopsy (TBLC)	Transbronchial Cryobiopsy，TBLC	Transbronchial lung cryobiopsy (TBLC) has been increasingly utilised to diagnose diffuse parenchymal lung diseases

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China