Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

Study Overview
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Brief Summary
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Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies done via bronchoscopy in the investigation of interstitial lung disease in comparison with videothoracoscopy-assisted surgical lung biopsy.

Detailed Description
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See above

Official Title
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DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Other: Transbronchial lung cryobiopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is planned for diagnostic investigation. Exclusion Criteria: Aged less than 18 y.o. Pregnancy Known coagulatoin disorder or blood dyscrasia Aaking antiplatelet agents other than aspirin or therapeutic anticoagulants drugs that cannot be safely discontinued to undergo lung biopsy Arterial oxgen pressure less than 60 mmHg on more than 2 liters per minute oxygen Known pulmonary hypertension defined as systolic PAP above 40 mmHg on echocardiography Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cryobiopsy<br> | Other: Transbronchial lung cryobiopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease | Number of cryobiopsy specimens from which a specific diagnosis of interstitial lung disease can be ascertained, as assessed by a two different pathologists blinded to the known final diagnosis. | After biopsy (up to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate of transbronchial cryobiopsy procedure | Assessment of complications related to cryoTBB: pneumothorax hemorrage other complications | Per-procedure and up to 24 hours after | 
| Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen | Diagnostic concordance between cryobiopsy specimen analysis and corresponding surgical lung biopsy done in same subjects (same lung/lobe) | After biopsy (up to 24 months) | 
| Inter-observer agreement for cryobiopsy specimens | Interobserver agreement rate between two different pathologists blinded to subject history/radiological record and surgical lung biopsy specimen. | After biopsy (up to 24 months) | 
| Size of cryobiopsy specimen | Size of TBB cryobiopsy specimen measured by two different pathologists responsible for its interpretation. | After biopsy (up to 24months) | 
| Quality of cyrobiopsy specimens | Pathological quality score of TBB cryobiopsy specimens (artefacts, size, etc.) as assessed by two different pathologists responsible for their interpretation. | After biopsy (up to 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ILD, Pulmonary fibrosis, Cryobiopsy, Transbronchial