Peripheral Airway Biopsy in Sarcoidosis (Sopranos)

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcoidosis, Pulmonary
• Intervention / Treatment: Procedure: Bronchoscopy with airway biopsy

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Fondazione Policlinico Univeristario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peripheral airway biopsy arm; All patients with clinical and radiological suspicion of sarcoidosis will be submitted to biopsy of peripheral airways (> 6th branching generation).	Procedure: Bronchoscopy with airway biopsy; Forceps biopsy of peripheral airways under direct endoscopic visualisation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Incidence of early complications	1 day
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Rocco Trisolini, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bronchoscopy; Sarcoidosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases; Hypersensitivity; Lung Diseases, Interstitial; Hypersensitivity, Delayed; Sarcoidosis, Pulmonary; Sarcoidosis
• Other Study ID Numbers: 5279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No