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The Role of Endobronchial Needle Aspiration With Rapid On-site Evaluation in the Diagnosis of Central Malignant Lesions

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EBNA with ROSE
standard EBNA
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring endobronchial needle aspiration (EBNA), transbronchial needle aspiration (TBNA), rapid on-site evaluation (ROSE), lung cancer

Eligibility Criteria

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

Inclusion Criteria:

  • consecutive adult patients with a suspected central lung cancer at a chest CT scan who need a bronchoscopy for diagnostic purposes

Exclusion Criteria:

  • presence of uncontrolled coagulopathy, preexisting known malignancies, and the refusal to sign an informed consent

Sites / Locations

  • Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1-EBNA with ROSE

1-EBNA without ROSE

Arm Description

Outcomes

Primary Outcome Measures

the sensitivity of the technique of endobronchial needle aspiration with rapid on-site evaluation for the diagnosis of endobronchial lung cancer
to determinate the sensitivity of endobronchial needle aspiration with rapid on-site evaluation compared to the conventional technique for the diagnosis of endobronchial lung cancer
the diagnostic yield of adding endobronchial needle aspiration (with and without rapid on-site evaluation) to conventional diagnostic methods for the diagnosis of endobronchial lung cancer
to investigate the diagnostic yield of adding endobronchial needle aspiration (with and without rapid on-site evaluation) to conventional diagnostic methods versus conventional diagnostic methods (bronchoscopy with forceps biopsies, bronchial brushing and bronchial washing) for the diagnosis of endobronchial lung cancer

Secondary Outcome Measures

the impact of rapid on-site evaluation on number of passes during endobronchial needle aspiration
study if the presence of rapid on-site evaluation during endobronchial needle aspiration may reduce the number of passes suggested by literature

Full Information

First Posted
October 20, 2011
Last Updated
May 19, 2014
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT01456741
Brief Title
The Role of Endobronchial Needle Aspiration With Rapid On-site Evaluation in the Diagnosis of Central Malignant Lesions
Official Title
Endobronchial Needle Aspiration With Rapid On-Site Evaluation in the Diagnosis of Central Malignant Lesions, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Endobronchial lung cancer tend to manifest in three different patterns. It can present as a bulky, exophytic mass lesion, submucosal infiltration or extrinsic compression from peribronchial disease. Bronchoscopy with differents techniques as forceps biopsy, bronchial brushing and bronchial washing is recognized as the gold standard to diagnose central airways lung neoplasms. Some authors suggested that the addition of endobronchial needle aspiration (EBNA) to these conventional diagnostic methods may increase the sensitivity of bronchoscopy in submucosal and peribronchial disease but few prospective trials have been performed and this procedure is still underutilized in many centers. Rapid on-site evaluation (ROSE) showed to improve yield of transbronchial needle aspiration (TBNA) of mediastinal nodes and pulmonary peripheral lesions, reducing the number of inadequate specimens and costs. However, its utility during endobronchial needle aspiration has not been substantiated. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
endobronchial needle aspiration (EBNA), transbronchial needle aspiration (TBNA), rapid on-site evaluation (ROSE), lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-EBNA with ROSE
Arm Type
Experimental
Arm Title
1-EBNA without ROSE
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
EBNA with ROSE
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
standard EBNA
Intervention Description
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
Primary Outcome Measure Information:
Title
the sensitivity of the technique of endobronchial needle aspiration with rapid on-site evaluation for the diagnosis of endobronchial lung cancer
Description
to determinate the sensitivity of endobronchial needle aspiration with rapid on-site evaluation compared to the conventional technique for the diagnosis of endobronchial lung cancer
Time Frame
10 day
Title
the diagnostic yield of adding endobronchial needle aspiration (with and without rapid on-site evaluation) to conventional diagnostic methods for the diagnosis of endobronchial lung cancer
Description
to investigate the diagnostic yield of adding endobronchial needle aspiration (with and without rapid on-site evaluation) to conventional diagnostic methods versus conventional diagnostic methods (bronchoscopy with forceps biopsies, bronchial brushing and bronchial washing) for the diagnosis of endobronchial lung cancer
Time Frame
10 days
Secondary Outcome Measure Information:
Title
the impact of rapid on-site evaluation on number of passes during endobronchial needle aspiration
Description
study if the presence of rapid on-site evaluation during endobronchial needle aspiration may reduce the number of passes suggested by literature
Time Frame
30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: consecutive adult patients with a suspected central lung cancer at a chest CT scan who need a bronchoscopy for diagnostic purposes Exclusion Criteria: presence of uncontrolled coagulopathy, preexisting known malignancies, and the refusal to sign an informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Mondoni, MD
Organizational Affiliation
Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paolo Carlucci, MD
Organizational Affiliation
Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefano Centanni, MD
Organizational Affiliation
Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano, Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica di Malattie dell'Apparato Respiratorio, Ospedale San Paolo, Università degli Studi di Milano
City
Milan
ZIP/Postal Code
20142
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

The Role of Endobronchial Needle Aspiration With Rapid On-site Evaluation in the Diagnosis of Central Malignant Lesions

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