The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases

March 6, 2019 updated by: ShiYue Li, Guangzhou Institute of Respiratory Disease

The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study

The Diagnostic yield and Safety of transbronchial cryobiopsy in the diagnosis of diffuse parenchymal lung diseases are investigated in this multicenter, prospective and real world study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

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

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230003
    • Beijing
      • Beijing, Beijing, China, 100029
        • Not yet recruiting
        • China-Japan Friendship Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361021
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital Sun Yat-Sen University
        • Contact:
        • Contact:
          • Xinyan Huang, PhD
          • Phone Number: 020-87755766-8171
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Southern Medical University Nanfang Hospital
        • Contact:
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangdong General Hospital
        • Contact:
        • Contact:
      • Shenzhen, Guangdong, China, 518036
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
        • Contact:
      • Shenzhen, Guangdong, China, 518106
        • Recruiting
        • Shenzhen Guangming New District People's Hospital
        • Contact:
        • Contact:
      • Zhongshan, Guangdong, China, 528415
        • Not yet recruiting
        • Affiliated Zhongshan Hospital of Guangdong Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430014
        • Not yet recruiting
        • The Central Hospital of Wuhan
        • Contact:
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Department of Respiratory and Critical Care Medicine，Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology
        • Contact:
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
      • Changsha, Hunan, China, 410005
        • Not yet recruiting
        • People's Hospital of Hunan Province
        • Contact:
        • Contact:
          • Wei Liu, PhD
          • Phone Number: 073183920874
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Not yet recruiting
        • Dalian Muncipal Central Hospital Affiliated of Dalian Medical University
        • Contact:
      • Shengyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Chest Hospital
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
      • Shanghai, Shanghai, China, 201112
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiao Tong University
        • Contact:
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710010
        • Recruiting
        • Xi'an Chest Hospital
        • Contact:
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China School of Medicine/West China Hospital of Sichuan University
        • Contact:
        • Contact:
      • MianYang, Sichuan, China, 621000
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
    • Taiwan
      • Taizhong, Taiwan, China, 40447
        • Not yet recruiting
        • China Medical University Hospital
        • Contact:
        • Contact:
    • Zhejiang
      • Jiaxing, Zhejiang, China, 314000
        • Recruiting
        • The First Hospital of Jiaxing
        • Contact:
        • Contact:
          • Na Li, MD
          • Phone Number: 0573-82082937

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients

Description

Inclusion Criteria:

  1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data.
  2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
  3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.

Exclusion Criteria:

  1. The radiological data indicates non-DPLD
  2. The clinical examinations mentioned above are not completed.
  3. The patient cannot endure or does not agree the procedure.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cryobiopsy
Transbronchial cryobiopsy is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.
Procedure: Transbronchial cryobiopsy
Transbronchial cryobiopsy procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnotic yield
Time Frame: two weeks
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 12 weeks
Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy (in 12 weeks).
12 weeks

Collaborators and Investigators

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

Sponsor

Guangzhou Institute of Respiratory Disease

Investigators

  • Study Chair: Shiyue Li, Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 1, 2018

Primary Completion (Anticipated)

October 20, 2020

Study Completion (Anticipated)

October 20, 2021

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-03-13

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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