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.
Procedure: Thoracic endosonography
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Full eligibility criteria for NCT01456429
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients with operable and resectable (suspected) NSCLC
Patients with clinical N1 staging based on PET/CT
Only T1, T2, and selected T3 (i.e. intraparenchymal tumour >7cm, chest wall, or additional nodule in the same lobe) are allowed.
Patients with enlarged mediastinal lymph nodes on chest CT or FDG-PET positive mediastinal lymph nodes
Patients with a central tumour staged T3 or any T4.
All stage IV patients.
Patient unable to give informed consent.
Patient previously underwent a mediastinoscopy.
Tracheal or upper airway stenosis.
All locations for NCT01456429
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Universitaire Ziekenhuizen leuven
Leuven, Belgium, 3000
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500
View full eligibility
Tris trial is registered with FDA with number: NCT01456429. The sponsor of the trial is Universitaire Ziekenhuizen Leuven and it is looking for 100 volunteers for the current phase.
Official trial title: Assessment of Surgical Mediastinal sTaging Added to Endoscopic Ultrasound in cN1 Lung canceR.
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