Know Cancer

or
forgot password

A Prospective Trial of Endobronchial Ultrasound- Transbronchial Needle Aspiration Compared to Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small Cell Lung

Thank you

Trial Information

A Prospective Trial of Endobronchial Ultrasound- Transbronchial Needle Aspiration Compared to Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer


Inclusion Criteria:



- Histology-proven non-small cell lung cancer

- N2 or N3 lymph node invasion is suspected based on chest CT or PET/CT scans (at
least one of three criteria) : 1) enlarged (1cm or more in short axis diameter)
mediastinal lymph node(s), 2) FDG uptake in the mediastinal lymph node(s), or 3) FDG
uptake in N1 node(s)

- The patient is otherwise considered a candidate for a surgical treatment with the
intention to cure

Exclusion Criteria:

- Distant metastasis

- Inoperable T4 disease

- Confirmed supraclavicular lymph node metastasis

- Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer

- Contraindications for bronchoscopy

- Uncorrected coagulopathy

- Concurrent other malignancies

- Suspicious mediastinal lymph node metastasis which are not accessible by EBUS-TBNA or
mediastinoscopy (i.e. paraaortic, aortopulmonary window, or paraesophageal lymph
nodes)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy.

Outcome Time Frame:

1 month interval

Safety Issue:

No

Principal Investigator

Sang-Won Um, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

South Korea: Institutional Review Board

Study ID:

2009-08-053

NCT ID:

NCT01079520

Start Date:

March 2010

Completion Date:

October 2012

Related Keywords:

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

Name

Location