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Peripheral Airway Biopsy in Sarcoidosis (Sopranos)

Primary Purpose

Sarcoidosis, Pulmonary

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Bronchoscopy with airway biopsy
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis, Pulmonary focused on measuring Sarcoidosis, Bronchoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione Policlinico Univeristario A. Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peripheral airway biopsy arm

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Complication rate
Incidence of early complications
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
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
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
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
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

Full Information

First Posted
February 6, 2023
Last Updated
September 21, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05759221
Brief Title
Peripheral Airway Biopsy in Sarcoidosis
Acronym
Sopranos
Official Title
A Pilot Study of Peripheral Airway Biopsy for the Diagnosis of Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Pulmonary
Keywords
Sarcoidosis, Bronchoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peripheral airway biopsy arm
Arm Type
Experimental
Arm Description
All patients with clinical and radiological suspicion of sarcoidosis will be submitted to biopsy of peripheral airways (> 6th branching generation).
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy with airway biopsy
Intervention Description
Forceps biopsy of peripheral airways under direct endoscopic visualisation.
Primary Outcome Measure Information:
Title
Diagnostic yield of peripheral airway biopsy for the detection of granulomas
Description
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).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Complication rate
Description
Incidence of early complications
Time Frame
1 day
Title
Diagnostic yield for the detection of endobronchial granulomas according to sex
Description
The association between the sex (male vs female) and the diagnostic yield of peripheral airway biopsy will be assessed
Time Frame
6 months
Title
Diagnostic yield for the detection of endobronchial granulomas according to the ethnicity
Description
The association between the ethnicity (white versus other) and the diagnostic yield of peripheral airway biopsy will be assessed
Time Frame
6 months
Title
Diagnostic yield for the detection of endobronchial granulomas according to the history of malignancy
Description
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
Time Frame
6 months
Title
Diagnostic yield for the detection of endobronchial granulomas according to the sarcoidosis stage
Description
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
Time Frame
6 months
Title
Diagnostic yield for the detection of endobronchial granulomas according to the presence of large airway mucosal abnormalities
Description
The association between the presence of endoscopically visible large airway abnormalities and the diagnostic yield of peripheral airway biopsy will be assessed
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Agrosì, MD
Phone
+3906314163
Email
a_kiara@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocco Trisolini, MD
Organizational Affiliation
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Univeristario A. Gemelli IRCCS
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiara Agrosì, MD
Email
a_kiara@hotmail.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Peripheral Airway Biopsy in Sarcoidosis

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