Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Surgical Mediastinal sTaging Added to Endoscopic Ultrasound in cN1 Lung canceR.

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Procedure: Thoracic endosonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracic endosonography<br>Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes | Procedure: Thoracic endosonography<br>* Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes<br>* Other names: thoracic echo-endoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC |  | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC |  | one month | 
| Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive staging, mediastinal lymph nodes, endosonography, surgical staging, lung cancer