Peripheral Airway Biopsy in Sarcoidosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Peripheral Airway Biopsy for the Diagnosis of Sarcoidosis

Conditions
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Sarcoidosis, Pulmonary

Intervention / Treatment
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* Procedure: Bronchoscopy with airway biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral airway biopsy arm<br>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<br>* Forceps biopsy of peripheral airways under direct endoscopic visualisation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of peripheral airway biopsy for the detection of granulomas | 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). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Incidence of early complications | 1 day | 
| Diagnostic yield for the detection of endobronchial granulomas according to sex | The association between the sex (male vs female) and the diagnostic yield of peripheral airway biopsy will be assessed | 6 months | 
| Diagnostic yield for the detection of endobronchial granulomas according to the ethnicity | The association between the ethnicity (white versus other) and the diagnostic yield of peripheral airway biopsy will be assessed | 6 months | 
| Diagnostic yield for the detection of endobronchial granulomas according to the history of malignancy | 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 | 6 months | 
| Diagnostic yield for the detection of endobronchial granulomas according to the sarcoidosis stage | 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 | 6 months | 
| Diagnostic yield for the detection of endobronchial granulomas according to the presence of large airway mucosal abnormalities | The association between the presence of endoscopically visible large airway abnormalities and the diagnostic yield of peripheral airway biopsy will be assessed | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoidosis, Bronchoscopy