Endobronchial Ultrasound vs Mediastinoscopy in NSCLC

NCT00372203 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-05-04

No results posted yet for this study

Summary

Proper staging of Lung cancer is of paramount concern when determining a treatment regime. Currently the assessment of surgical candidacy is performed with the staging process, mainly the mediastinoscopy. A mediastinoscopy has the ability to access samples of the paratracheal lymph node stations (Levels 2R, 2L, 3, 4R, 4L), as well as the anterior subcarinal lymph node station (Level 7). In comparison, the EBUS-TBNA technique is a real-time procedure that has the potential to access the same paratracheal and subcarinal lymph node stations associated with the mediastinoscopy, but also extending out to the hilar lymph nodes (Levels 10 and 11). Because of the possibility of extended sampling range and a reduction in procedural invasiveness, EBUS-TBNA may represent a more efficient patient centered alternative to mediastinoscopy in the staging of lung cancer patients. Additionally, patients who are have lymph nodes in the N2 region frequently undergo chemotherapy and/or radiotherapy prior to surgery. Assessment of the lymph nodes after chemo/radiation is done using CT scans, as re-mediastinoscopy is a technically difficult procedure. These patients may benefit from EBUS-TBNA.

Conditions

Interventions

PROCEDURE

Endobronchial Ultrasound Guided Transthoracic Needle Biopsy

Endobronchial Ultrasound Guided Transthoracic Needle Biopsy of mediastinal lymph nodes at the time of the mediastinoscopy.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Shaf Keshavjee, MD MSc FRCSC FACS · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00372203 on ClinicalTrials.gov