External ValidatIon Trial of ASTER Trial (EVITA)
Recruitment status was: Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||External ValidatIon Trial of Aster: the Need for Surgical Staging After Echo-endoscopic Mediastinal Staging in Clinical N2/3 Lung Cancer|
- The number of mediastinoscopies needed to detect one additional N2/3 [ Time Frame: 1 month ] [ Designated as safety issue: No ]Efficacy
- The number of mediastinal lymph nodes stations sampled with endosonography [ Time Frame: 1 month ] [ Designated as safety issue: No ]Characteristics of nodal staging; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Endoscopic ultrasonography (EBUS-TBNA +/- EUS-FNA) for invasive mediastinal nodal staging
Procedure: Endoscopic ultrasonography
in order to stage the mediastinum
Background : The observation made by the ASTER investigators might be criticized as all procedures were performed in highly experienced centers. To date, the number of mediastinoscopies needed to detect one additional N2/3 disease in the routine clinical practice of chest physician performing endosonography for mediastinal staging is unknown. The investigators therefore seek to answer whether a negative endosonography should routinely be followed by mediastinoscopy in day to day clinical practice.
Aim : As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice.
Setting : centers in Belgium with EBUS-TBNA and/or EUS-FNA experience in at least 20 patients agreed to participate and will include their patients.
Design : Prospective national observational multicenter study. All patients with clinical N2/3 disease based on CT and/or PET requiring invasive mediastinal staging will primarily undergo invasive mediastinal staging with endosonography (EBUS +/- EUS). A subsequent cervical mediastinoscopy will be performed in case no mediastinal lymph node involvement was found with endosonography. Local surgeons perform these procedures according to their institutional practice. Thoracotomy with mediastinal lymph node dissection will be the gold standard for invasive mediastinal staging, in case no mediastinal lymph node metastases were found during clinical staging including endosonography and mediastinoscopy.
Patients : The study will include 255 patients, based on the calculation of 15 consecutive patients in each participating center, in order to validate the ASTER data.
Primary endpoint : The number of mediastinoscopies needed to detect one additional N2/3.
Secondary endpoints : The number of mediastinal lymph nodes stations sampled with endosonography ; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332240
|Sint-Jan Ziekenhuis Brugge|
|Hopital Erasme Brussels|
|Centre Hospitalier Universitaire de Charleroi|
|Universitair Ziekenhuis Antwerpen|
|Univeristair Ziekenhuis Brussel|
|Center Hospitalier Jolimont|
|La Louvière, Belgium|
|Heilig Hart Ziekenhuis|
|Sint-Elisabeth en Sint-Jozef ziekenhuis|
|Principal Investigator:||Christophe Dooms||Universitaire Ziekenhuizen Leuven|
|Principal Investigator:||Kurt Tournoy||University Hospital Ghent Belgium|