Assessment of Invasive Mediastinal Staging in cN1 Lung Cancer.

Not Applicable

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: Thoracic endosonography

• Registration Number: NCT01456429
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracic endosonography	Thoracic endosonography	Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes

Primary Outcome Measures

Name	Time	Method
Sensitivity of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC	One month

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness analysis for echo-endoscopy in cN1 disease NSCLC	one month
NPV of echo-endoscopic mediastinal staging in operable and resectable cT1-2-selectedT3 cN1 NSCLC	one month

Trial Locations

Locations (3)

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

Universitaire Ziekenhuizen leuven; 🇧🇪 Leuven, Belgium