Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Transbronchial Cryobiopsy; Pulmonary Fibrosis

Treatments: Procedure: Transbronchial Lung Biopsy，TBLB; Procedure: Transbronchial Cryobiopsy，TBLC

Study type: Interventional

Funder types: Other

Identifiers

NCT06251687

ZRJY2021-BJ08-03-01-02

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Transbronchial Cryobiopsy (TBLC)

Experimental group

Description:

Transbronchial lung cryobiopsy (TBLC) has been increasingly utilised to diagnose diffuse parenchymal lung diseases

Treatment:

Procedure: Transbronchial Cryobiopsy，TBLC

Transbronchial Lung Biopsy (TBLB)

Active Comparator group

Description:

Transbronchial lung biopsy (TBLB) is a relatively safe technique routinely employed by pulmonologists for the diagnosis of diffuse parenchymal lung disease

Treatment:

Procedure: Transbronchial Lung Biopsy，TBLB