Bronchoscopic EmphysemA Treatment in THE NetherLands
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bronchoscopic Lung Volume Reduction Treatment in Clinical Practice: Introduction and Implementation in The Netherlands and Evaluation of a National Database
Overview
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.
Primary outcome measures
- Quality of treatment [Time frame: Baseline-30 days]
Secondary outcome measures (5)
- Change from baseline in lungfunction at 5 years follow up after treatment. [Time frame: Baseline- 5 years]
- Change from baseline in exercise capacity at 5 years follow up after treatment. [Time frame: Baseline- 5 years]
- Change from baseline in breathlessness at 5 years follow up after treatment. [Time frame: Baseline- 5 years]
- Change from baseline in health status at 5 years follow up after treatment. [Time frame: Baseline- 5 years]
- The incidence of a pneumothorax after the treatment until 5 years follow up. [Time frame: Baseline- 5 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- University Medical Center Groningen — Groningen
- Maastricht University Medical Center — Maastricht
Publications
- Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6. PMID 39515624
- Hartman JE, Klooster K, Ten Hacken NHT, van Dijk M, Slebos DJ. Patient Satisfaction and Attainment of Patient-Specific Goals after Endobronchial Valve Treatment. Ann Am Thorac Soc. 2021 Jan;18(1):68-74. doi: 10.1513/AnnalsATS.202004-342OC. PMID 32881586
Identifiers
NCT: NCT02815683 · BREATHE-NL