Learn about Research & Clinical Trials

Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06251687
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	China-Japan Friendship Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Fibrosis, Transbronchial Cryobiopsy

Arms & Interventions

Arms

Experimental: Transbronchial Cryobiopsy (TBLC)

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

Active Comparator: 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

Interventions

Procedure: - Transbronchial Cryobiopsy，TBLC

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

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