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

February 2, 2016 updated by: Stefano Gasparini, Azienda Ospedaliero, Universitaria Ospedali Riuniti

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Marche
      • Ancona, Marche, Italy, 60100
        • Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti'

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional TBNA + ROSE

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
Device: EBUS-TBNA
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
Experimental: EBUS-TBNA + ROSE
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
Device: EBUS-TBNA
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies
Time Frame: 36 months
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%
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of TBNA and EBUS-TBNA
Time Frame: 36 months
Specificity is defined as the rate of true negatives diagnoses /true negative + false positive
36 months
Sensitivity of EBUS-TBNA performed after the possible failure of traditional TBNA
Time Frame: 36 months
36 months
Number of partecipants with adverse events
Time Frame: 36 months
36 months
Costs related to each diagnostic strategy
Time Frame: 36 months
It will be evaluated the cost related to the whole procedure, including the possible shift to EBUS-TBNA.
36 months
Procedural time
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Investigators

  • Principal Investigator: Stefano Gasparini, Professor, Azienda Ospedaliero, Universitaria Ospedali Riuniti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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