The Role of Endobronchial Needle Aspiration With Rapid On-site Evaluation in the Diagnosis of Central Malignant Lesions
NCT ID: NCT01456741
Last Updated: 2014-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
134 participants
INTERVENTIONAL
2011-08-31
2012-04-30
Brief Summary
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This prospective study has two primary objectives: to compare the sensitivity of ROSE-EBNA with that of the conventional technique and to investigate the diagnostic yield of endobronchial needle aspiration and its contribution to CDM in the evaluation of patients with endobronchial lesions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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1-EBNA with ROSE
EBNA with ROSE
The patients in this arm will undergo:
A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence with rapid on-site evaluation
B) if A will be negative transthoracic needle aspiration or surgical biopsy will be performed
C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography
1-EBNA without ROSE
standard EBNA
The patients in this arm will undergo:
A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence.
B)if A will be negative transthoracic needle aspiration or surgical biopsy will be performed
C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography
Interventions
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EBNA with ROSE
The patients in this arm will undergo:
A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence with rapid on-site evaluation
B) if A will be negative transthoracic needle aspiration or surgical biopsy will be performed
C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography
standard EBNA
The patients in this arm will undergo:
A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence.
B)if A will be negative transthoracic needle aspiration or surgical biopsy will be performed
C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Milan
OTHER
Responsible Party
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Fabiano Di Marco
M.D., Ph.D.
Principal Investigators
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Michele Mondoni, MD
Role: STUDY_DIRECTOR
Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Paolo Carlucci, MD
Role: STUDY_CHAIR
Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Stefano Centanni, MD
Role: PRINCIPAL_INVESTIGATOR
Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Locations
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Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano
Milan, Milan, Italy
Countries
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Other Identifiers
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EBNA08091976
Identifier Type: -
Identifier Source: org_study_id
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