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Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies

Primary Purpose

Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Lymphoma

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
EBUS-TBNA
Sponsored by
Azienda Ospedaliero, Universitaria Ospedali Riuniti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mediastinal Lymphadenopathy focused on measuring transbronchial needle aspiration, ultrasound guided transbronchial needle aspiration, sensitivity, hilar/mediastinal adenopathy

Eligibility Criteria

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

Inclusion Criteria:

  • age ≥ 18years;
  • presence of at least one hilar/mediastinal adenopathy >1 cm on short axis assessed by contrast-enhanced CT scan in at least one approachable stations other than 2R and 2L;
  • ability to give an informed consent.

Exclusion Criteria:

  • presence of mediastinal adenopathy in stations 2R and 2L;
  • coagulopathy or bleeding diathesis that cannot be corrected;
  • severe refractory hypoxemia;
  • unstable hemodynamic status;
  • inability to give an informed consent.

Sites / Locations

  • Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti'

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional TBNA + ROSE

EBUS-TBNA + ROSE

Arm Description

Patients allocated in this group will undergo conventional TBNA, performed in a bronchoscopy suite by the same operator under conscious sedation, using 19-G needle size. Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist. In case of samples obtained from conventional TBNA defined as "non diagnostic", the operator will shift to the EBUS procedure.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs

Patients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs

Outcomes

Primary Outcome Measures

To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies
The sensitivity is defined as the rate of true positive diagnoses/(true positive + false negative). Sensitivity of EBUS-TBNA will be considered superior to that of conventional TBNA if it will achieve at least a value of 90%

Secondary Outcome Measures

Specificity of TBNA and EBUS-TBNA
Specificity is defined as the rate of true negatives diagnoses /true negative + false positive
Sensitivity of EBUS-TBNA performed after the possible failure of traditional TBNA
Number of partecipants with adverse events
Costs related to each diagnostic strategy
It will be evaluated the cost related to the whole procedure, including the possible shift to EBUS-TBNA.
Procedural time

Full Information

First Posted
August 1, 2012
Last Updated
February 2, 2016
Sponsor
Azienda Ospedaliero, Universitaria Ospedali Riuniti
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1. Study Identification

Unique Protocol Identification Number
NCT01658280
Brief Title
Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies
Official Title
Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration, Using Rapid On-site Cytological Evaluation, for the Diagnosis of Hilar/Mediastinal Enlarged Lymph Nodes: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Ospedali Riuniti

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of the present study is to assess whether the sensitivity of Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.
Detailed Description
The role of transbronchial needle aspiration (TBNA) for the diagnosis of hilar/mediastinal adenopathy and lung cancer staging is well established. However, it is a blind procedure and its diagnostic yield seems to be related to the operator experience, as well as to the size and location of lymph nodes. In the recent years, there has been increased interest in imaging-assisted TBNA and the endobronchial ultrasound has been suggested to be feasible and to improve the diagnostic yield. Another technique able to optimize the performance of transbronchial aspirations is the rapid on-site cytological examination (ROSE), allowing to assess the adequacy of samples collected. In this context, no comparative studies between standard TBNA and EBUS-TBNA have been performed. It is very important for clinical practice to definitively assess the possible superiority of EBUS-TBNA in terms of sensitivity, and to provide information regarding safety, procedural time and costs to define the best diagnostic strategy. The study is focused on 252 patients who have at least one hilar/mediastinal lymph node > 1 cm on CT scan in at least one approachable lymph nodal station (except 2R and 2L) for which a diagnostic cyto-histological assessment is required for clinical purpose. Patients will be randomized 1:1 (control : intervention) by a computer-generated random-allocation system to undergo EBUS-TBNA or conventional TBNA. In case of failure of conventional TBNA, the operator will shift to EBUS procedure. Moreover,a subgroup analysis will be perform to assess the potential impact of lymphnode size and position on final results(univariate analysis).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Lymphoma, Lung Neoplasms, Sarcoidosis
Keywords
transbronchial needle aspiration, ultrasound guided transbronchial needle aspiration, sensitivity, hilar/mediastinal adenopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional TBNA + ROSE
Arm Type
Active Comparator
Arm Description
Patients allocated in this group will undergo conventional TBNA, performed in a bronchoscopy suite by the same operator under conscious sedation, using 19-G needle size. Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist. In case of samples obtained from conventional TBNA defined as "non diagnostic", the operator will shift to the EBUS procedure.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs
Arm Title
EBUS-TBNA + ROSE
Arm Type
Experimental
Arm Description
Patients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs
Intervention Type
Device
Intervention Name(s)
EBUS-TBNA
Intervention Description
Patients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs
Primary Outcome Measure Information:
Title
To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies
Description
The sensitivity is defined as the rate of true positive diagnoses/(true positive + false negative). Sensitivity of EBUS-TBNA will be considered superior to that of conventional TBNA if it will achieve at least a value of 90%
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Specificity of TBNA and EBUS-TBNA
Description
Specificity is defined as the rate of true negatives diagnoses /true negative + false positive
Time Frame
36 months
Title
Sensitivity of EBUS-TBNA performed after the possible failure of traditional TBNA
Time Frame
36 months
Title
Number of partecipants with adverse events
Time Frame
36 months
Title
Costs related to each diagnostic strategy
Description
It will be evaluated the cost related to the whole procedure, including the possible shift to EBUS-TBNA.
Time Frame
36 months
Title
Procedural time
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 18years; presence of at least one hilar/mediastinal adenopathy >1 cm on short axis assessed by contrast-enhanced CT scan in at least one approachable stations other than 2R and 2L; ability to give an informed consent. Exclusion Criteria: presence of mediastinal adenopathy in stations 2R and 2L; coagulopathy or bleeding diathesis that cannot be corrected; severe refractory hypoxemia; unstable hemodynamic status; inability to give an informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Gasparini, Professor
Organizational Affiliation
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti'
City
Ancona
State/Province
Marche
ZIP/Postal Code
60100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
14718460
Citation
Herth F, Becker HD, Ernst A. Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial. Chest. 2004 Jan;125(1):322-5. doi: 10.1378/chest.125.1.322.
Results Reference
background
PubMed Identifier
15824520
Citation
Gasparini S. It is time for this 'ROSE' to flower. Respiration. 2005 Mar-Apr;72(2):129-31. doi: 10.1159/000084041. No abstract available.
Results Reference
background
PubMed Identifier
12527575
Citation
Toloza EM, Harpole L, Detterbeck F, McCrory DC. Invasive staging of non-small cell lung cancer: a review of the current evidence. Chest. 2003 Jan;123(1 Suppl):157S-166S. doi: 10.1378/chest.123.1_suppl.157s.
Results Reference
background

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Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies

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