Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432640
Status:
COMPLETED
Last Update Posted:
2010-12-16
First Post:
2007-02-07
Brief Title:
Assessment of Surgical sTaging vs Endoscopic Ultrasound in Lung Cancer a Randomized Clinical Trial ASTER Study
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None