Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.

Study Overview
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Brief Summary
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The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease

Detailed Description
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Endoscopic biopsy currently plays only a minor role for the diagnosis of interstitial lung disease. However, in some cases obtaining lung tissue is necessary to establish a final diagnosis. The current standard procedure is transbronchial forceps biopsy - if not sufficient: surgical lung biopsy. Transbronchial lung biopsy bears essential limitations however: Small tissue sample Limited evaluability of the material caused by forceps-induced crush artifacts In cryobiopsy the cryoprobe´s tip is being cooled and thereby cools the surrounding tissue to approximately minus 89 degrees Celsius. Subsequently, the frozen probe is retracted with the frozen tissue being attached onto the frozen probe's tip. When applied in the central airways, cryobiopsy proved to deliver large specimens of good quality, which may exceed forceps biopsies in terms of diagnostic yield. Pilot studies on transbronchial cryobiopsy showed that same advantages as seen in the endobronchial use.

Official Title
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Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Procedure: transbronchial lung biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical indications for biopsy of interstitial lung disease Age over 18 years Signed consent Exclusion Criteria: Risk of bleeding / ongoing anticoagulation Oxygen saturation <90% - despite delivery of 2l oxygen / min Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure) Pulmonary hypertension, PAP sys> 50mmHg

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transbronchial forceps lung biopsy<br>transbronchial lung biopsy forceps | Procedure: transbronchial lung biopsy<br> <br> |
| Active Comparator: transbronchail cryo lung biopsy<br>transbronchial lungbiopsy with cryoprobe | Procedure: transbronchial lung biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in the final diagnosis |  | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interstitial lung disease, transbronchial biopsy, cryobiopsy