A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

February 17, 2024 updated by: Gang Hou, China-Japan Friendship Hospital

Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Retrospective Study

The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The goal of this observational 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: • The diagnostic rate of MDD1 or MDD2 based on TBLC. • The rate of hemorrhage, pneumothorax, acute ILD exacerbation and mortality. Participants' medical records will be collected by us.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingming Deng, PhD
  • Phone Number: +86 18801336854
  • Email: isdeng@163.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients receiving TBLC for progressive pulmonary fibrosis

Description

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 50,000e+9/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic rate of MDD2 based on TBLC
Time Frame: December，31，2024
the diagnostic rate of progressive pulmonary fibrosis after Transbronchial Cryobiopsy
December，31，2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic rate of MDD1
Time Frame: December，31，2024
the diagnostic rate of progressive pulmonary fibrosis before Transbronchial Cryobiopsy
December，31，2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2024

Primary Completion (Estimated)

December 24, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZRJY2021-BJ08-03-01-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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