COPD
Conditions
Keywords
Bronchoscopy, Emphysema
Brief summary
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
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.
Interventions
None listed
Sponsors
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of treatment | Baseline-30 days | Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in lungfunction at 5 years follow up after treatment. | Baseline- 5 years | -Change from baseline in lungfunction measured by the bodybox at 5 years follow up. |
| Change from baseline in exercise capacity at 5 years follow up after treatment. | Baseline- 5 years | -Change from baseline in exercise capacity measured by the 6-minute walk distance test at 5 years follow up. |
| Change from baseline in breathlessness at 5 years follow up after treatment. | Baseline- 5 years | -Change from baseline in breathlessness measured by the mMRC-scale (modified medical research council) at 5 years follow up. |
| Change from baseline in health status at 5 years follow up after treatment. | Baseline- 5 years | -Change from baseline in health status measured by the CAT (COPD Assessment test) score at 5 years follow up. |
| The incidence of a pneumothorax after the treatment until 5 years follow up. | Baseline- 5 year | The number of pneumothoraxes will be recorded between treatment and 5 years follow up. |
Countries
Netherlands
Contacts
Primary ContactKarin Klooster, PhD
Outcome results
None listed