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The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927235
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
ShiYue Li, Guangzhou Institute of Respiratory Disease

Brief Summary:
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.

Condition or disease Intervention/treatment Phase
Transbronchial Cryobiopsy Freezing Time Diagnostic Yield Safety Procedure: Transbronchial Cryobiopsy Not Applicable

Detailed Description:
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. This is a prospective randomized control trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: the freezing time of 3s
Transbronchial cryobiopsy in the freezing time of 3s
Procedure: Transbronchial Cryobiopsy
Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

Experimental: the freezing time of 4s
Transbronchial cryobiopsy in the freezing time of 4s
Procedure: Transbronchial Cryobiopsy
Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

Experimental: the freezing time of 5s
Transbronchial cryobiopsy in the freezing time of 5s
Procedure: Transbronchial Cryobiopsy
Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases

Experimental: the freezing time of 6s
Transbronchial cryobiopsy in the freezing time of 6s
Procedure: Transbronchial Cryobiopsy
Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases




Primary Outcome Measures :
  1. Diagnotic yield [ Time Frame: two weeks ]
    Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: one week ]
    Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927235


Contacts
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Contact: Xiaobo Chen, master +8613751721744 xiaobo-win@163.com
Contact: Shiyue Li, master +8613902233925 lishiyue@188.com

Locations
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China, Guangdong
the First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Shiyue Li, professor    13902233925    lishiyue@188.com   
Contact: Yao Yao, Dr    18826401822    yaoyaogy2016@163.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
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Responsible Party: ShiYue Li, Director of the Respiratory department, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT03927235    
Other Study ID Numbers: 2018-3-30
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ShiYue Li, Guangzhou Institute of Respiratory Disease:
Transbronchial Cryobiopsy
freezing time
Diagnostic Yield
Safety
Diffuse Parenchymal Lung Disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases