Peripheral Airway Biopsy in Sarcoidosis

NCT ID: NCT05759221

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2024-03-31

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.

Conditions

Sarcoidosis, Pulmonary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Peripheral airway biopsy arm

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

Group Type: EXPERIMENTAL

Bronchoscopy with airway biopsy

Intervention Type: PROCEDURE

Forceps biopsy of peripheral airways under direct endoscopic visualisation.

Interventions

Bronchoscopy with airway biopsy

Forceps biopsy of peripheral airways under direct endoscopic visualisation.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rocco Trisolini, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Univeristario A. Gemelli IRCCS

Roma, , Italy

Countries

Italy

Other Identifiers

5279

Identifier Type: -

Identifier Source: org_study_id