Clinical trial NCT01658280: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mediastinal Lymphadenopathy
Hilar Lymphadenopathy
Lymphoma
Lung Neoplasms
Sarcoidosis
Keywords: transbronchial needle aspiration
ultrasound guided transbronchial needle aspiration
sensitivity
hilar/mediastinal adenopathy
Lead sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies
timeFrame: 36 months
Secondary outcomes:
measure: Specificity of TBNA and EBUS-TBNA
timeFrame: 36 months
measure: Sensitivity of EBUS-TBNA performed after the possible failure of traditional TBNA
timeFrame: 36 months
measure: Number of partecipants with adverse events
timeFrame: 36 months
measure: Costs related to each diagnostic strategy
timeFrame: 36 months
measure: Procedural time
timeFrame: 36 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti'
state: Marche
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Ospedali Riuniti
name: Stefano Gasparini, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.