Evaluation of Preoperative Endobronchial Ultrasound (EBUS) in Non Small Cell Lung Cancer (NSCLC)
EVIEPEB
Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging
2 other identifiers
observational
363
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 18, 2013
January 1, 2013
2.2 years
August 14, 2009
January 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of mediastinoscopy avoided
24h
Study Arms (1)
NON SMALL CELL LUNG CANCER
Non small cell lung cancer, with clinical N2 disease, otherwise operable.
Interventions
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
Eligibility Criteria
This study will include non small cell lung cancer patients, stage III A (before PET Scan), with resectable tumors.
You may qualify if:
- adult patients over 18
- non small cell lung cancer histologically or cytologically proved
- Clinical Stage IIIA
- anatomically and functionally resectable
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rouen University Hospital
Rouen, 76000, France
Related Publications (1)
Chouaid C, Salaun M, Gounant V, Febvre M, Vergnon JM, Jouniaux V, Fournier C, Lachkar S, Hermant C, Raspaud C, Quantin X, Quiot JJ, Molard A, Dayen C, Marquette CH, Lena H, Zalcman G, Thiberville L. Clinical efficacy and cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration for preoperative staging of non-small-cell lung cancer: Results of a French prospective multicenter trial (EVIEPEB). PLoS One. 2019 Jan 7;14(1):e0208992. doi: 10.1371/journal.pone.0208992. eCollection 2019.
PMID: 30615623DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 17, 2009
Study Start
September 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
January 18, 2013
Record last verified: 2013-01