Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer: a Randomized Clinical Trial (ASTER Study)
Lung cancer is one of the most prevalent cancers and has a very high mortality. Both treatment and prognosis depend on the staging. Surgical staging of the mediastinum mainly by means of a cervical mediastinoscopy is the gold standard. Mediastinal staging is however a field that undergoes a fast technological development. Transesophageal ultrasound guided fine-needled aspiration (EUS-FNA) and an endobronchial ultrasound guided transbronchial fine-needled aspiration (EBUS-TBNA) are two complementary endoscopic ultrasound techniques which together allow cytological analysis of all mediastinal lymph nodes. This means that the combination of both techniques enables a complete (bilateral) mediastinal investigation (N2 and N3, except para-aortal station 6).
Hypothesis: complete endoscopic ultrasound staging identifies more patients with locally advanced disease compared to surgical staging (current standard of care).
Study design: A randomized controlled multi-center double arm diagnostic phase III trial, in which patients are randomly assigned to either surgical staging (arm B) or endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA (arm A).
Arm A: Examination by EUS-FNA and EBUS-TBNA. These techniques are performed in an outpatient one session setting under conscious sedation and take together about 30 to 60 minutes. If no metastasis are shown, the patient undergoes a surgical staging procedure (for confirmation). For reasons of convenience and patient-comfort, the EUS-FNA investigation is performed before the EBUS-TBNA.
Arm B: Surgical staging with either cervical mediastinoscopy, parasternal mediastinoscopy, thorascopic mediastinal exploration or exploratory thoracotomy, performed according to institutional practice.
Patients in whom no lymph node metastasis are found proceed to thoracotomy with systematic lymph node sampling to obtain an accurate intraoperative mediastinal staging.
Primary outcome: The assessment of N2-N3 lymph node metastases.
|Carcinoma, Non-Small-Cell Lung||Procedure: Endoscopic ultrasound staging Procedure: Surgical staging|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial|
- We hypothesize that the combination of EUS and EBUS in an out-patient one-session setting is more sensitive for the detection of locally advanced disease (N2/N3) compared to surgical staging (standard of care)
- Assessment of mediastinal tumour invasion (T4)
- Assessment of the rate of avoided surgical procedures (arm A)
- Assessment of the negative predictive value
- Assessment of the difference in the cost for lymph node staging
- Assessment of the complication rates
- Assessment of the rate of futile thoracotomies
- Assessment of quality of life (EQ5D)
|Study Start Date:||January 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Endoscopic ultrasound staging
Procedure: Endoscopic ultrasound staging
Endoscopic ultrasound staging with both EUS-FNA and EBUS-TBNA
Active Comparator: 2
Procedure: Surgical staging
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432640
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|Leuven University Hospital|
|Leuven, Belgium, 3000|
|Leidens Universitair Medisch Centrum (LUMC)|
|Papworth University Hospital|
|Cambridge, United Kingdom|
|Principal Investigator:||Kurt Tournoy, MD, PhD||University Hospital, Ghent|
|Principal Investigator:||Jouke Annema, MD||Leidens Universitair Medisch Centrum|