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

NCT ID: NCT00960271

Last Updated: 2013-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NON SMALL CELL LUNG CANCER

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

EBUS

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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NSCLC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30615623 (View on PubMed)

Other Identifiers

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EVIEPEB

Identifier Type: -

Identifier Source: secondary_id

2007/138/HP

Identifier Type: -

Identifier Source: org_study_id

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