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Endobronchial Ultrasound vs Mediastinoscopy in NSCLC

Prospective Controlled Trial of Mediastinoscopy Compared With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Assessment of the Mediastinum in Lung Cancer.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00372203
Enrollment
200
Registered
2006-09-06
Start date
2006-07-31
Completion date
2010-03-31
Last updated
2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer, NSCLC, EBUS, Endobronchial ultrasound, mediastinoscopy

Brief 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.

Interventions

PROCEDUREEndobronchial Ultrasound Guided Transthoracic Needle Biopsy

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

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

A) Age 18 years or older B) Patients with confirmed or suspected non-small cell lung cancer who require a mediastinoscopy as part of their staging investigations of the mediastinum to determine suitability for lung cancer resection will be considered for the trial. C) Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required.

Exclusion criteria

A) Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy or a mediastinoscopy or who are not suitable for definitive surgical resection by thoracotomy will be excluded. B) Patients who have verified stage IV disease or who are not appropriate for lung cancer resection by virtue of direct invasion of mediastinal structures or large parts of the chest wall. C) Known small cell lung cancer. D) Patients where there is a high clinical suspicion of lymphoma. E) Inability to give informed consent.

Design outcomes

Primary

MeasureTime frame
Sensitivity1 day

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026