Bronchoscopic EmphysemA Treatment in THE NetherLands

Study Overview
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Brief Summary
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Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies. Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Detailed Description
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Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies. Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations. Study design: This study is a nationwide, multicenter, observational post-marketing study with long-term follow up (5 years). Study population: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves. Main study parameters/endpoints: The main study parameter is the assessment of Target Lung Volume Reduction (TLVR) and correct placement of the valves at CT-scan at 30 days post treatment. This is the most accurate and directly treatment related endpoint which will also be used for quality control.

Official Title
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Bronchoscopic Lung Volume Reduction Treatment in Clinical Practice: Introduction and Implementation in The Netherlands and Evaluation of a National Database

Conditions
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COPD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves. Exclusion Criteria: There are no exclusion criteria for this study.
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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of treatment | Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves. | Baseline-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in lungfunction at 5 years follow up after treatment. | -Change from baseline in lungfunction measured by the bodybox at 5 years follow up. | Baseline- 5 years | 
| Change from baseline in exercise capacity at 5 years follow up after treatment. | -Change from baseline in exercise capacity measured by the 6-minute walk distance test at 5 years follow up. | Baseline- 5 years | 
| Change from baseline in breathlessness at 5 years follow up after treatment. | -Change from baseline in breathlessness measured by the mMRC-scale (modified medical research council) at 5 years follow up. | Baseline- 5 years | 
| Change from baseline in health status at 5 years follow up after treatment. | -Change from baseline in health status measured by the CAT (COPD Assessment test) score at 5 years follow up. | Baseline- 5 years | 
| The incidence of a pneumothorax after the treatment until 5 years follow up. | The number of pneumothoraxes will be recorded between treatment and 5 years follow up. | Baseline- 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy, Emphysema