The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 25, 2019
CompletedStudy Start
First participant enrolled
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2020
CompletedMay 30, 2019
May 1, 2019
1 year
April 23, 2019
May 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnotic yield
Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy
two weeks
Secondary Outcomes (1)
Complication rate
one week
Study Arms (4)
the freezing time of 3s
SHAM COMPARATORTransbronchial cryobiopsy in the freezing time of 3s
the freezing time of 4s
EXPERIMENTALTransbronchial cryobiopsy in the freezing time of 4s
the freezing time of 5s
EXPERIMENTALTransbronchial cryobiopsy in the freezing time of 5s
the freezing time of 6s
EXPERIMENTALTransbronchial cryobiopsy in the freezing time of 6s
Interventions
Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The radiological data indicates non-DPLD
- The clinical examinations mentioned above are not completed.
- The patient cannot endure or does not agree the procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Respiratory department
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 25, 2019
Study Start
May 16, 2019
Primary Completion
May 15, 2020
Study Completion
May 15, 2020
Last Updated
May 30, 2019
Record last verified: 2019-05