Status:
COMPLETED
The Value of Surgical Mediastinal Staging in Clinical N1 Lung Cancer
Lead Sponsor:
Johnny Moons
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-90 years
Brief Summary
In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for echo-endoscopy t...
Detailed Description
Few reports in the literature evaluated the final pathological stage distribution of patients with resectable and operable non-small cell lung cancer (NSCLC) with clinical stage cN1. These retrospecti...
Eligibility Criteria
Inclusion
- (Suspected) NSCLC Medical operable and surgical resectable cT1, cT2 selected cT3 (i.e. intraparenchymal tumour \>7cm, T3 chest wall, or T3 based on additional nodule in the lobe of the primary tumour) cN1 based on CT or PET 18 years or older Informed Consent
Exclusion
- History of mediastinoscopy No integrated FDG PET/CT available No videomediastinoscopy available EBUS/EUS for mediastinal staging of present N1 disease cN2: mediastinal nodes enlarged on CT or Pet positive invasion of mediastinal pleura invasion of phrenic nerve invasion of parietal pericardium tumour in main bronchus less than 2cm form the main carina cT4 cM1 former therapy for lung cancer (chemotherapy, radiotherapy, surgery) technical contraindication for videomediastinoscopy ( eg extreme kyphosis, cutaneous tracheostomy, extreme goiter) pregnancy inability to consent
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2017
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02222194
Start Date
August 1 2014
End Date
May 30 2017
Last Update
July 25 2017
Active Locations (10)
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1
University Hospital Leuven
Leuven, Belgium, 3000
2
Aix-Marseille University & Hospitals System of Marseille (AP-HM)
Marseille, France, 13915
3
ELK Berlin Chest Hospital
Berlin, Germany, 13125
4
Albert-Ludwigs-University Freiburg
Freiburg im Breisgau, Germany, 79106