This is a prospective non-randomized multicenter clinical trial performing endobronchial and esophageal ultrasound for mediastinal lymph node staging of operable and resectable cT1-T2-selectedT3 cN1 cM0 NSCLC.
Provided no mediastinal lymph node metastases are proven by echoendoscopy, all patients will subsequently undergo surgical staging. Patients without tissue proof of mediastinal nodal disease at surgical staging will undergo a thoracotomy with systematic lymph node dissection. Provided mediastinal lymph node metastases are proven by echoendoscopy, the patient goes off study protocol and can further be assessed/treated according to local clinical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitaire Ziekenhuizen leuven
Leuven, Belgium
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
Time frame: One month
NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC
Time frame: one month
Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC
Time frame: one month
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