Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

China-Japan Friendship Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Pulmonary Fibrosis Transbronchial Cryobiopsy

Interventions

Transbronchial lung cryobiopsy (TBLC) is a novel technique that has proved its diagnostic value in various diffuse parenchymal lung diseases

Transbronchial Lung Biopsy，TBLBPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

the diagnostic performance of transbronchial cryobiopsy（TBLC）

the sensitivity and specificity of transbronchial cryobiopsy（TBLC）in suspected progressive pulmonary fibrosis

Time frame: 1 month after transbronchial cryobiopsy

Secondary Outcomes

the safety of transbronchial cryobiopsy（TBLC)

The occurence of short-term procedure-related complications, including Bleeding, pneumothorax, death, etc

Time frame: 7 days and 1 month after transbronchial cryobiopsy

Data from ClinicalTrials.gov

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