Sopranos: Peripheral Airway Biopsy in Sarcoidosis
Study Details
Study Description
Brief Summary
Airway involvement in sarcoidosis was demonstrated in a meaningful, albeit variable, proportion of patients through biopsy of the central, endoscopically visible airways. Ideally, biopsy of peripheral airways, nowadays possible with the introduction in the market of ultrathin bronchoscopes, might be associated with an increased diagnostic yield for the detection of granulomas.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Sarcoidosis is a systemic disorder of unknown cause that primarily involves the lung and lymphatic systems and that is more reliably diagnosed if a compatible clinical picture is combined with a pathologic demonstration of non-necrotizing epithelioid-cell granulomas. Endobronchial biopsy (EBB), taken from the central airways with standard-sized videobronchoscopes, has long been used in clinical practice, although its diagnostic yield has been shown to be widely variable across different ethnicities. A recent prospective study shows that the diagnostic yield of EBB in a sarcoidosis population with large prevalence of white Europeans is 37% overall, and 22% in patients who do not have endobronchial abnormalities. The diagnostic yield of biopsies taken from peripheral airways with ultrathin bronchoscopes was never been evaluated, to our knowledge.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Peripheral airway biopsy arm All patients with clinical and radiological suspicion of sarcoidosis will be submitted to biopsy of peripheral airways (> 6th branching generation). |
Procedure: Bronchoscopy with airway biopsy
Forceps biopsy of peripheral airways under direct endoscopic visualisation.
|
Outcome Measures
Primary Outcome Measures
- Diagnostic yield of peripheral airway biopsy for the detection of granulomas [1 month]
The diagnostic yield will be calculated on a per patient basis (number of patients in whom the pathological examination of peripheral airway biopsy shows non necrotizing granulomas/all the patients submitted to the sampling procedure).
Secondary Outcome Measures
- Complication rate [1 day]
Incidence of early complications
- Diagnostic yield for the detection of endobronchial granulomas according to sex [6 months]
The association between the sex (male vs female) and the diagnostic yield of peripheral airway biopsy will be assessed
- Diagnostic yield for the detection of endobronchial granulomas according to the ethnicity [6 months]
The association between the ethnicity (white versus other) and the diagnostic yield of peripheral airway biopsy will be assessed
- Diagnostic yield for the detection of endobronchial granulomas according to the history of malignancy [6 months]
The association between a history of malignancy (presence versus absence of any malignancy diagnosed within 5 years of the procedure) and the diagnostic yield of peripheral airway biopsy will be assessed
- Diagnostic yield for the detection of endobronchial granulomas according to the sarcoidosis stage [6 months]
The association between the sarcoidosis stage at CT (I vs II vs II vs IV) and the diagnostic yield of peripheral airway biopsy will be assessed
- Diagnostic yield for the detection of endobronchial granulomas according to the presence of large airway mucosal abnormalities [6 months]
The association between the presence of endoscopically visible large airway abnormalities and the diagnostic yield of peripheral airway biopsy will be assessed
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Necessity of a pathological confirmation of the clinical and radiological (CT) diagnosis of sarcoidosis.
-
Age >18 years
-
American Society of Anesthesiologists score 1-3.
Exclusion Criteria:
-
Inability of unwillingness to consent
-
Steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy.
-
Pregnancy.
-
Uncontrolled coagulopathy
-
Contraindication to the temporary interruption of anticoagulants or antiplatelet drugs, except aspirin.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Univeristario A. Gemelli IRCCS | Roma | Italy |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Rocco Trisolini, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5279