Clinical trial NCT02815683: Bronchoscopic EmphysemA Treatment in THE NetherLands
Official title: Bronchoscopic Lung Volume Reduction Treatment in Clinical Practice: Introduction and Implementation in The Netherlands and Evaluation of a National Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Keywords: Bronchoscopy
Emphysema
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

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.

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.

Primary outcomes:
measure: Quality of treatment
timeFrame: Baseline-30 days
Secondary outcomes:
measure: Change from baseline in lungfunction at 5 years follow up after treatment.
timeFrame: Baseline- 5 years
measure: Change from baseline in exercise capacity at 5 years follow up after treatment.
timeFrame: Baseline- 5 years
measure: Change from baseline in breathlessness at 5 years follow up after treatment.
timeFrame: Baseline- 5 years
measure: Change from baseline in health status at 5 years follow up after treatment.
timeFrame: Baseline- 5 years
measure: The incidence of a pneumothorax after the treatment until 5 years follow up.
timeFrame: Baseline- 5 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: UMCG
name: Dirk-Jan Slebos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.