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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Azienda Ospedaliero, Universitaria Ospedali Riuniti
Sponsor:
Information provided by (Responsible Party):
Stefano Gasparini, Azienda Ospedaliero, Universitaria Ospedali Riuniti
ClinicalTrials.gov Identifier:
NCT01658280
First received: August 1, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Mediastinal Lymphadenopathy
Hilar Lymphadenopathy
Lymphoma
Lung Neoplasms
Sarcoidosis
Device: EBUS-TBNA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero, Universitaria Ospedali Riuniti:

Primary Outcome Measures:
  • To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Number of partecipants with adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Costs related to each diagnostic strategy [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    It will be evaluated the cost related to the whole procedure, including the possible shift to EBUS-TBNA.

  • Procedural time [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658280

Contacts
Contact: Stefano Gasparini, Professor +39-0715965694 s.gasparini@fastnet.it
Contact: Martina Bonifazi, MD +39-0715964353 martinabonifazi@libero.it

Locations
Italy
Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' Recruiting
Ancona, Marche, Italy, 60100
Contact: Stefano Gasparini, Professor    +39-0715965694    s.gasparini@fastnet.it   
Principal Investigator: Stefano Gasparini, Professor         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Investigators
Principal Investigator: Stefano Gasparini, Professor Azienda Ospedaliero-Universitaria Ospedali Riuniti Ancona
  More Information

Publications:
Responsible Party: Stefano Gasparini, Professor, Azienda Ospedaliero, Universitaria Ospedali Riuniti
ClinicalTrials.gov Identifier: NCT01658280     History of Changes
Other Study ID Numbers: PAN-001
Study First Received: August 1, 2012
Last Updated: August 20, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliero, Universitaria Ospedali Riuniti:
transbronchial needle aspiration
ultrasound guided transbronchial needle aspiration
sensitivity
hilar/mediastinal adenopathy

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Lymphoma
Sarcoidosis
Lymphatic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014