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

Non Small Cell Lung Cancer Clinical Trial

— EVIEPEB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960271
• Other study ID #: 2007/138/HP
• Secondary ID: EVIEPEB
• Status: Completed
• Phase: N/A
• First received: August 14, 2009
• Last updated: January 17, 2013
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of mediastinoscopy avoided		24h	No