In this study we aim to assess: 1.the diagnostic yield of endobronchial biopsy taken during HD videobronchoscopy in a large study population;2. the prevalence, visual pattern and specificity (for the detection of granulomas) of airway abnormalities…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic yield of endobronchial biopsy guided by HD videobronchoscopy for the
detection of granulomas
Secondary outcome
- Prevalence of airway abnormalities in patients with suspected sarcoidosis at
HD bronchoscopy
- Prevalence of different patterns of airway abnormalities in patients with
suspected sarcoidosis at HD videobronchoscopy
- Specificity for the detection of granulomas of the above 6 different patterns
of airway abnormalities identified during HD bronchoscopy
- The interobserver agreement for the identification of the above 6 predefined
patterns of airway abnormalities.
- Diagnostic yield for the detection of endobronchial granulomas according to
clinical, radiological and endoscopic findings.
The association between the following findings and the diagnostic yield of EBBs
will be assessed: sex; ethnicity; sarcoidosis stage (I-IV); presence versus
absence of endobronchial abnormalities at HD bronchoscopy; pattern of airway
abnormality at HD bronchoscopy.
Background summary
Sarcoidosis is a systemic disease of unknown etiology that can be diagnosed in
the presence of a compatible clinical picture and a pathological finding of
non-necrotizing epithelial granulomas in one of the affected organs.
Since sarcoidosis is a pathology with thoracic involvement (bronchi, lung
parenchyma and/or intrathoracic lymph nodes) almost always present,
bronchoscopy and bronchoscopic sampling methods (endobronchial and
transbronchial biopsies, bronchioloalveolar lavage, conventional transbronchial
and/or ultrasound-guided fine needle aspirations ultrasound-guided
transesophageal) are almost always used for the pathological confirmation of
clinical suspicion of sarcoidosis.
Endobronchial biopsies, one of the simplest and safest sampling procedures to
perform, with a diagnostic yield varying between 18% and 71%, always increases
the diagnostic success of bronchoscopy in sarcoidosis when associated with
other sampling procedures.
Predictors of succesfull endobronchial biopsies in sarcoidosis are associated
with the African-American race and the presence of bronchial mucosal changes
visible during bronchoscopy. However, even in the absence of alterations of the
bronchial mucosa, in approximately 37% of the cases, it is possible to find the
presence of non-necrotizing granulomas on endobronchial biopsies performed on
apparently normal mucosa. This presupposes a microscopic involvement of the
bronchial mucosa, not visible or not clearly visible on standard bronchoscopy,
in a non-negligible percentage of patients with sarcoidosis. Consequently, an
imaging method that helps identify bronchial mucosal involvement when present
but not clearly visible with standard bronchoscopy, could increase the
diagnostic yield of endobronchial biopsies. This is an advantage since this
approach is less invasive than other lung parenchymal procedures
(transbronchial biopsies), and less expensive than lymph node sampling
procedures (EBUS-TBNA, EUS-B-FNA).
In recent years, the new high definition (HD) video bronchoscopes have become
commercially available which, compared to standard bronchoscopes, offer a much
higher image definition and, combined with the new video processors, allow for
"real-time" methods to "post-processing* of the image which are particularly
useful to study bronchial vascularization (i-scan technology).
Our hypothesis is that HD video bronchoscopy could help identify bronchial
involvement of sarcoidosis before it is clearly visible on standard
bronchoscopy.
Study objective
In this study we aim to assess:
1.the diagnostic yield of endobronchial biopsy taken during HD
videobronchoscopy in a large study population;
2. the prevalence, visual pattern and specificity (for the detection of
granulomas) of airway abnormalities seen during HD + OE
videobronchoscopy in patients with suspected sarcoidosis.
Study design
prospective, multicenter, observational cohort study
Study burden and risks
Bronchoscopy and the endobronchial sampoling methods to be preformed in the
current study are routinely performed in clinical practice for the diagnosis of
sarcoidosis and are considered safe, but every procedure has its risks. There
is a small chance of infection and bleeding when taking biopsies. The risk for
these complications when participating in the study is comparable to the
standard procedure.
The bronchoscopic procedure can take a few minutes longer because short video
recordings will be taken of the sampling locations. This is not a burden for
the patiënts as they will be sedated according to standard procedures
Largo Agostino Gemelli 8
Roma 00168
IT
Largo Agostino Gemelli 8
Roma 00168
IT
Listed location countries
Age
Inclusion criteria
a) indication to a pathological confirmation of the clinical and radiological
(CT)
suspect of sarcoidosis;
b) age > 18 years;
c) ASA score 1-3.
Exclusion criteria
a) inability to consent;
b) steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy;
c) pregnancy;
d) uncontrolled coagulopathy;
e) contraindication to temporary interruption of anticoagulants or antiplatelet
drugs, except aspirin;
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT04743596 |
| CCMO | NL77709.018.21 |