Clinical Trials Directory

Trials / Completed

CompletedNCT05759221

Peripheral Airway Biopsy in Sarcoidosis

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
79 (actual)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBronchoscopy with airway biopsyForceps biopsy of peripheral airways under direct endoscopic visualisation.

Timeline

Start date
2022-10-20
Primary completion
2023-12-31
Completion
2024-03-31
First posted
2023-03-08
Last updated
2024-04-05

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05759221. Inclusion in this directory is not an endorsement.