Diagnostic Value of Transbronchial Lung Cryobiopsy

Study Overview
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Brief Summary
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Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics

Detailed Description
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Before one is able to state that TBLC is a technique that is an alternative for VATS biopsy, the diagnostic value of TBLC should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. For this purpose direct comparison between VATS biopsy and TBLC is unavoidable. By including TBLC in the work-up of patients with DILD in which histopathological assessment is indicated (as proposed by MDD), we want to assess 3 major points of concern. Agreement for the histopathological diagnosis between VATS biopsy and TBLC. Value of TBLC in the specific diagnosis in ILD.

Official Title
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Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Procedure: transbronchial lung cryobiopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Case of DILD presented at the MDD Referral for VATS biopsy as advised by MDD. Informed consent available Age > 18 FVC > 50%pred DLCO > 40%pred PaO2 > 65 mmHg, pCO2 < 45 mmHg No exclusion criteria Exclusion Criteria: - Age > 75 PAPS >40mmHg as measured on transthoracic cardiac ultrasound Platelet count <100000/µl INR > 1.4 BMI >30 Diffuse bullous lung disease Active anti-platelet or anticoagulant treatment Active heart failure or unstable coronary heart disease Patients unfit for VATS under general anaesthesia as assessed by the surgeon and/or anesthesiologist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: transbronchial lung cryobiopsy|bronchoscopic sampling|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histopathological agreement | Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedural safety : bleeding | incidence of bleeding (number of case) | periprocedural 1 hour | 
| procedural safety : bleeding (2) | severity of bleeding (grade 1-2-3) | periprocedural 1 hour | 
| procedural safety : bleeding (3) | duration of bleeding (seconds) | periprocedural 1 hour | 
| procedural safety : penumothorax | pneumothorax rate (number of cases) | periprocedural 1 hour |