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NCT06251687 Clinical Trial

Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

Pulmonary Fibrosis Clinical Trial

Official title:
Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06251687
Other study ID # ZRJY2021-BJ08-03-01-02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date December 31, 2026

Study information
Verified date February 2024
Source China-Japan Friendship Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Transbronchial Cryobiopsy,TBLC
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
China-Japan Friendship Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary the diagnostic performance of transbronchial cryobiopsy(TBLC) the sensitivity and specificity of transbronchial cryobiopsy(TBLC)in suspected progressive pulmonary fibrosis 1 month after transbronchial cryobiopsy
Secondary the safety of transbronchial cryobiopsy(TBLC) The occurence of short-term procedure-related complications, including Bleeding, pneumothorax, death, etc 7 days and 1 month after transbronchial cryobiopsy
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