NCT00960271

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

Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 363 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	EBUS	a minimally invasive technique of mediastinal lymph node staging using an integrated videoendoscopic device equipped with ultrasound for the localization and transbronchial sampling of lymph nodes in real time

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2009-08-17
• Last updated: 2013-01-18

Locations

1 site across 1 country: France