Endobronchial Ultrasound Versus Mediastinoscopy in Patients With Non-Small Cell Lung Cancer (NSCLC)
The goal of this clinical research study is to compare 2 different methods for checking lymph glands (in the middle of the chest) for cancer cells.
The aim of this prospective study is to determine the staging accuracy of endobronchial ultrasound guided fine needle aspiration biopsy of mediastinal lymph nodes compared to the 'gold standard', mediastinoscopy, in patients with clinical Stage IIIA non-small cell lung cancer.
To determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal metastases.
To estimate quantitative and qualitative differences regarding sampling of mediastinal nodes (number and location of nodes biopsied, number and location of positive nodes, extracapsular extension, ability to biopsy contralateral nodes).
To determine the frequency of change of planned therapeutic management resulting from outcome of EBUS-FNA and mediastinoscopy.
To determine procedure related complications. To perform analysis of cost between EBUS-FNA and mediastinoscopy.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Prospective Comparison of Endobronchial Ultrasound Needle Biopsy Versus Mediastinoscopy for Staging of Mediastinal Nodes in Patients With Clinical Stage IIIA Non-Small Cell Lung Cancer (NSCLC)|
- Number Patients Restaged Upwards by Mediastinoscopy Following EBUS Evaluation [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Outcome defined as how many patients EBUS stage N0/1 actually end up being N2/3, and how many EBUS stage N2 actually are N3 by mediastinoscopy. Study primarily interested in an upper limit on this proportion. Primary analysis is the upper one-sided 90% confidence limit.
|Study Start Date:||October 2007|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Endobronchial Ultrasound vs. Mediastinoscopy
Endobronchial Ultrasound - A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope.
Mediastinoscopy - Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS.
Procedure: Endobronchial Ultrasound
A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope.
Other Name: EBUSProcedure: Mediastinoscopy
Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS.
The current procedure used to check for cancer cells in the lungs is a small operation at the base of the neck (mediastinoscopy) to get samples of the lymph glands. These samples are then looked at under the microscope to see if they contain cancer cells. A procedure has been developed that may allow doctors to get samples of lymph glands without having to perform an operation. This is called endobronchial ultrasound or "EBUS". The purpose of this study is to compare the 2 procedures.
If you agree to take part in this study, your insurance provider will be contacted. In order for you to take part in this study, your insurance provider must agree to pay for both the EBUS and mediastinoscopy procedures.
If your insurance provider agrees to pay for both procedures, you will be scheduled for the EBUS and a mediastinoscopy. The procedures will not be scheduled on the same day. You will first have the EBUS. You will receive general anesthesia and a small flexible scope will be passed down your windpipe. Samples of your lymph gland tissue will then be collected through a tiny needle that is passed through the scope. This will be performed as an out patient procedure.
If a tumor is found on the opposite side of your chest from another tumor by the EBUS, a mediastinoscopy will not be necessary.
If a tumor is not found on the opposite side of your chest from another tumor by the EBUS, you will then have a mediastinoscopy. This is also an outpatient procedure that will involve a small (2 cm) cut at the base of the neck, just above the breast bone. Your doctor will then pass a special scope with a camera into your chest (below the breast bone). This will allow your doctor to see the lymph glands around your windpipe and get samples of them. This will also be performed under general anesthesia and you will be able to leave the hospital shortly after the procedure.
Depending on whether or not the lymph glands have cancer in them, your doctor will then recommend the best therapy for the tumor to you.
This is an investigational study. The EBUS is FDA approved. The mediastinoscopy is considered standard of care. The comparison of the 2 procedures is investigational.
Up to 100 patients will be take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559611
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David C. Rice, MD||M.D. Anderson Cancer Center|