Peripheral Airway Biopsy in Sarcoidosis

Sarcoidosis, Pulmonary Clinical Trial

— Sopranos  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05759221
• Other study ID #: 5279
• Status: Completed
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Procedure:
• Bronchoscopy with airway biopsy
Forceps biopsy of peripheral airways under direct endoscopic visualisation.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Univeristario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complication rate	Incidence of early complications	1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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