Peripheral Airway Biopsy in Sarcoidosis (Sopranos)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Sarcoidosis, Pulmonary

Treatments: Procedure: Bronchoscopy with airway biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05759221

5279

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Peripheral airway biopsy arm

Experimental group

Description:

All patients with clinical and radiological suspicion of sarcoidosis will be submitted to biopsy of peripheral airways (\> 6th branching generation).

Treatment:

Procedure: Bronchoscopy with airway biopsy