Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

Study Overview
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Brief Summary
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The purpose of this study is to assess efficiency and safety of cryobiopsy compared to video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases (ILD). To that end, this non-interventional study prospectively collects data from patients undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to VATS if this procedure is reasonable. The information gained by this study will help to assess the significance of cryobiopsy in contrast to VATS in this particular disease group.

Official Title
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Cryobiopsy vs. VATS: Efficiency and Safety in the Diagnosis of Interstitial Lung Diseases

Conditions
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Interstitial Lung Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Known or newly diagnosed interstitial lung disease (ILD) Indication for lung biopsy for definitive ILD diagnosis Informed Consent provided Exclusion Criteria: Age < 18 years Inability or contraindication to undergo any form of invasive diagnostic procedure associated with diagnosis of interstitial lung disease Severely restricted CO diffusion capacity (<50%) Pregnancy, lactation Any medical, psychological or other condition restricting the patient's ability to provide informed consent Participation in another clinical trial

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ILD diagnosis<br>Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of diagnostic cryobiopsies | For the individual study participant, the result of the cryobiopsy (whether it is diagnostically helpful, i.e. diagnostic or not, i.e. inconclusive) will be documented when it is available, which will be within 3 days. The overall number of diagnostic cryobiopsies will be calculated once the study is complete. | up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications during cryobiopsy | Number of complications associated with cryobiopsy, divided into three categories of severity: mild/moderate/severe | During and up to 48 hours after procedure | 
| Rate of complications during VATS | Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe | During and up to 10 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial Lung Disease, Diagnosis, Cryobiopsy, Video-assisted thoracic surgery, Lung biopsy