Endobronchial Ultrasound Versus Mediastinoscopy in Patients With Non-Small Cell Lung Cancer (NSCLC)
Summary
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.
Primary Objective:
-To determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal metastases.
Secondary Objectives:
- 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.
Description
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.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
Lung Cancer
Intervention
Endobronchial Ultrasound, Mediastinoscopy
Location
U.T.M.D. Anderson Cancer Center
Houston
Texas
United States
77030
Status
Recruiting
Source
M.D. Anderson Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00559611
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Ultrasound, High-intensity Focused, Transrectal
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
Lung Neoplasms
Tumors or cancer of the LUNG.
Carcinoma, Bronchogenic
Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
Tumor Suppressor Protein P53
Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.
Ultrasonography, Interventional
The use of ultrasound to guide minimally invasive surgical procedures such as needle ASPIRATION BIOPSY; DRAINAGE; etc. Its widest application is intravascular ultrasound imaging but it is useful also in urology and intra-abdominal conditions.
Clinical Trials
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