The main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of ELVR treatment with EBVs.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The BIO-EXEL study is an observational study to investigate the biological
mechanisms underlying the adverse granulation and fibrotic responses upon
treatment with endobronchial lung valves. Therefore, the primary outcomes
encompassment biological measurements indicating susceptibility for these
adverse effects, including soluble factors (serum, bronchial wash biomarkers),
genetic factors, and histological factors. Primary study parameters further
include factors elaborating the underlying biological mechanisms of these
adverse effects, including the presence of specific cell-types at the site of
granulation and fibrotic responses, the presence of specific protein and
biofilm signatures on the explanted endobronchial lung valves.
Secondary outcome
not applicable
Background summary
COPD is a severe, often progressive and currently incurable lung disease which
affects both the upper airways (chronic bronchitis) as well as the lower
airways (emphysema). In advanced stages of the disease air-trapping severely
reduces the ability to breathe and subsequently the quality of life. A highly
effective treatment for restoring lung mechanical functionality of these
patients is the introduction of bronchoscopic lung volume reduction, e.g.
implanting small silicone/nitinol valves inside the airways to reduce
air-trapping. Although successfully investigated in a selected group of severe
COPD patients, the effectiveness of the treatment was in most patients
short-lived due to fibrotic and granulation responses and tissue-material
interactions.
Study objective
The main objective of this study is to study and understand the underlying
biological principles of granulation and fibrotic responses limiting the
effectiveness and longevity of ELVR treatment with EBVs.
Study design
150 consequtive severe COPD patients getting endobronchial lung valves in the
context of regular care, will be enrolled within the study in order to collect
biological materials. Prior to and during the bronchoscopic procedure samples
will be collected. Patients who are re-hospitalized and in need for valve
replacement or removal within a time-period of 18 months are asked to provide a
second set of samples during the standard bronchoscopy (estimated n=20-30).
Eighteen months after enrolment, 20 patients who did not experience any
problems with the endobronchial valves will be invited to the hospital for a
bronchoscopic treatment during which a set of samples will be collected.
Study burden and risks
No additional study related interventions besides the collection of samples
will be applied to the patients, with the exception of the complaint-free group
which will receive one additional bronchoscopic intervention. The bronchoscopic
treatments which are in the context of regular care are increased in length by
approximately 10 minutes upon enrollment within the BIO-EXEL study. The
collection of biological materials are routinely performed and have been proven
risk-free so far. No further risks are associated with this study.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Patients with severe emphysema who undergo an endoscopic lung volume reduction
treatment with endobronchial valves
Written informed consent.
Exclusion criteria
Anticoagulation which cannot be stopped
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72533.042.20 |