Peripheral Airway Biopsy in Sarcoidosis

NCT05759221 | Completed

• 1 other identifier: 5279
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis, Pulmonary

Keywords

Sarcoidosis; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Complication rate

  1 day

• Diagnostic yield for the detection of endobronchial granulomas according to sex

  6 months

• Diagnostic yield for the detection of endobronchial granulomas according to the ethnicity

  6 months

• Diagnostic yield for the detection of endobronchial granulomas according to the history of malignancy

  6 months

• Diagnostic yield for the detection of endobronchial granulomas according to the sarcoidosis stage

  6 months

Study Arms (1)

Peripheral airway biopsy arm

EXPERIMENTAL

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

Interventions

Bronchoscopy with airway biopsy PROCEDURE

Forceps biopsy of peripheral airways under direct endoscopic visualisation.

Peripheral airway biopsy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Necessity of a pathological confirmation of the clinical and radiological (CT) diagnosis of sarcoidosis.
• Age \>18 years
• American Society of Anesthesiologists score 1-3.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Univeristario A. Gemelli IRCCS

Roma, Italy

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary; Sarcoidosis

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Rocco Trisolini, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 8, 2023
• Study Start: October 20, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)