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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial

Conditions
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Transbronchial Cryobiopsy, Freezing Time, Diagnostic Yield, Safety

Intervention / Treatment
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* Procedure: Transbronchial Cryobiopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: the freezing time of 3s<br>Transbronchial cryobiopsy in the freezing time of 3s | Procedure: Transbronchial Cryobiopsy<br>* Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases<br>|
| Experimental: the freezing time of 4s<br>Transbronchial cryobiopsy in the freezing time of 4s | Procedure: Transbronchial Cryobiopsy<br>* Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases<br>|
| Experimental: the freezing time of 5s<br>Transbronchial cryobiopsy in the freezing time of 5s | Procedure: Transbronchial Cryobiopsy<br>* Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases<br>|
| Experimental: the freezing time of 6s<br>Transbronchial cryobiopsy in the freezing time of 6s | Procedure: Transbronchial Cryobiopsy<br>* Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnotic yield | 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 | Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transbronchial Cryobiopsy, freezing time, Diagnostic Yield, Safety, Diffuse Parenchymal Lung Disease