Evaluation of Preoperative Endobronchial Ultrasound (EBUS) in Non Small Cell Lung Cancer (NSCLC) (EVIEPEB)

University Hospital, Rouen

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Procedure: EBUS

Study type: Observational

Funder types: Other

Identifiers

NCT00960271

EVIEPEB

2007/138/HP

Details and patient eligibility

About

This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.

Enrollment: 363 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients over 18
• non small cell lung cancer histologically or cytologically proved
• Clinical Stage IIIA
• anatomically and functionally resectable

Exclusion criteria

• uncorrected bleeding disorders
• absence of lymphadenopathy superior to 1cm in small axis at CT scan
• contraindication to bronchoscopy
• extrathoracic or intrathoracic metastasis
• respiratory function tests not compatible with curative resection of lung cancer

Trial design

363 participants in 1 patient group

NON SMALL CELL LUNG CANCER

Description:

Non small cell lung cancer, with clinical N2 disease, otherwise operable.

Treatment:

Procedure: EBUS