Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

NCT ID: NCT06251687

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Pulmonary Fibrosis Transbronchial Cryobiopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transbronchial Cryobiopsy (TBLC)

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

Group Type EXPERIMENTAL

Transbronchial Cryobiopsy,TBLC

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Transbronchial Lung Biopsy,TBLB

Intervention Type PROCEDURE

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

Interventions

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Transbronchial Cryobiopsy,TBLC

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gang Hou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Mingming Deng

Role: primary

+86 18801336854

Other Identifiers

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ZRJY2021-BJ08-03-01-02

Identifier Type: -

Identifier Source: org_study_id

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