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

Primary Purpose

Transbronchial Cryobiopsy, Freezing Time, Diagnostic Yield

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transbronchial Cryobiopsy
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transbronchial Cryobiopsy focused on measuring Transbronchial Cryobiopsy, freezing time, Diagnostic Yield, Safety, Diffuse Parenchymal Lung Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the First Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

the freezing time of 3s

the freezing time of 4s

the freezing time of 5s

the freezing time of 6s

Arm Description

Transbronchial cryobiopsy in the freezing time of 3s

Transbronchial cryobiopsy in the freezing time of 4s

Transbronchial cryobiopsy in the freezing time of 5s

Transbronchial cryobiopsy in the freezing time of 6s

Outcomes

Primary Outcome Measures

Diagnotic yield
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy

Secondary Outcome Measures

Complication rate
Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy

Full Information

First Posted
April 23, 2019
Last Updated
May 28, 2019
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT03927235
Brief Title
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Anticipated)
Study Completion Date
May 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transbronchial Cryobiopsy, Freezing Time, Diagnostic Yield, Safety
Keywords
Transbronchial Cryobiopsy, freezing time, Diagnostic Yield, Safety, Diffuse Parenchymal Lung Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the freezing time of 3s
Arm Type
Sham Comparator
Arm Description
Transbronchial cryobiopsy in the freezing time of 3s
Arm Title
the freezing time of 4s
Arm Type
Experimental
Arm Description
Transbronchial cryobiopsy in the freezing time of 4s
Arm Title
the freezing time of 5s
Arm Type
Experimental
Arm Description
Transbronchial cryobiopsy in the freezing time of 5s
Arm Title
the freezing time of 6s
Arm Type
Experimental
Arm Description
Transbronchial cryobiopsy in the freezing time of 6s
Intervention Type
Procedure
Intervention Name(s)
Transbronchial Cryobiopsy
Intervention Description
Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases
Primary Outcome Measure Information:
Title
Diagnotic yield
Description
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Complication rate
Description
Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed. Exclusion Criteria: The radiological data indicates non-DPLD The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaobo Chen, master
Phone
+8613751721744
Email
xiaobo-win@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyue Li, master
Phone
+8613902233925
Email
lishiyue@188.com
Facility Information:
Facility Name
the First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, professor
Phone
13902233925
Email
lishiyue@188.com
First Name & Middle Initial & Last Name & Degree
Yao Yao, Dr
Phone
18826401822
Email
yaoyaogy2016@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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