Clinical trial NCT05759221: Peripheral Airway Biopsy in Sarcoidosis
Official title: A Pilot Study of Peripheral Airway Biopsy for the Diagnosis of Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis, Pulmonary
Keywords: Sarcoidosis
Bronchoscopy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic yield of peripheral airway biopsy for the detection of granulomas
timeFrame: 1 month
Secondary outcomes:
measure: Complication rate
timeFrame: 1 day
measure: Diagnostic yield for the detection of endobronchial granulomas according to sex
timeFrame: 6 months
measure: Diagnostic yield for the detection of endobronchial granulomas according to the ethnicity
timeFrame: 6 months
measure: Diagnostic yield for the detection of endobronchial granulomas according to the history of malignancy
timeFrame: 6 months
measure: Diagnostic yield for the detection of endobronchial granulomas according to the sarcoidosis stage
timeFrame: 6 months
measure: Diagnostic yield for the detection of endobronchial granulomas according to the presence of large airway mucosal abnormalities
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Univeristario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Rocco Trisolini, MD
role: PRINCIPAL_INVESTIGATOR
References: