Trial Information

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 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).