Peripheral Airway Biopsy in Sarcoidosis

Not Applicable

Completed

• Conditions: Sarcoidosis, Pulmonary
• Interventions: Procedure: Bronchoscopy with airway biopsy

• Registration Number: NCT05759221
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2022-10-20
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral airway biopsy arm	Bronchoscopy with airway biopsy	All patients with clinical and radiological suspicion of sarcoidosis will be submitted to biopsy of peripheral airways (\> 6th branching generation).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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
Complication rate	1 day	Incidence of early complications

Trial Locations

Locations (1)

Fondazione Policlinico Univeristario A. Gemelli IRCCS; 🇮🇹 Roma, Italy