Diagnostic Utility of Endobronchial Ultrasound Guided Mediastinal Lymph Node Sampling in Clinical Stage I and II Non Small Cell Lung Cancer
A procedure called EBUS-TBNA has been developed that might allow doctors to get samples of
lymph glands without performing an operation. The standard practice is a surgical operation
called a mediastinoscopy. If researchers find out that EBUS-TBNA is as accurate as
mediastinoscopy, it may mean that patients with lung cancer can avoid having surgery or will
be able to get treatment before surgery.
If you agree to take part in this study, you will first have an EBUS-TBNA. This will be
performed on an out-patient basis under general anesthetic. The doctor will examine your
lungs for suspicious lymph glands with an ultrasound, and then will take a sample of tissue
from the lymph gland. This will be done using a flexible scope called a bronchoscope that
can be passed into the windpipe. The lymph glands around the wind pipe can be seen and then
removed with a small needle. The procedure should take about 1 hour.
Researchers will then analyze the lymph glands that were removed. Depending on whether or
not the lymph glands have cancer in them, your doctor will then recommend the most
appropriate therapy for you. This may include mediastinoscopy or some other appropriate
All the data for the study will be stored with a password protected system.
Length of Study:
Your participation in this study will be over after you have completed EBUS-TBNA.
This is an investigational study. EBUS-TBNA is FDA approved for this procedure.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with false negative rate using EBUS guided mediastinal lymph node biopsy
Patient participation 1 hour to complete EBUS-TBNA
George A. Eapen, M.D.
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|