Endobronchial Ultrasound Versus Mediastinoscopy in Patients With Non-Small Cell Lung Cancer (NSCLC)

17:59 EDT 21st August 2014 | BioPortfolio

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)

View Results

Links

Clinical Trials [1722 Associated Clinical Trials listed on BioPortfolio]

Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) Versus Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer (NSCLC)

Accurate staging of the mediastinum is essential to evaluate prognosis in non-small cell lung cancer and to devise an appropriate treatment plan. Mediastinal staging by surgical techniques...

Endobronchial Ultrasound vs Mediastinoscopy in NSCLC

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...

A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)

In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. The investigators wish to determine whether using th...

A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)

Enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a variety of different causes. In the past an operation (mediastinoscopy) was required to diagno...

Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer.

Bronchoscopy of non visible lesions in the lung, have a low diagnostic yield. The use of endoscopic ultrasound might increase the diagnostic yield. This prospective study randomises betwee...

PubMed Articles [18107 Associated PubMed Articles listed on BioPortfolio]

Endobronchial Ultrasound-guided Biopsy Performed Under Optimal Conditions in Patients With Known or Suspected Lung Cancer May Render Mediastinoscopy Unnecessary.

Mediastinoscopy is the gold standard for preoperative mediastinal staging of patients with suspected or proven lung cancer. Since the development of endoscopic ultrasound-guided biopsy via the trachea...

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA): An overview and update for the cytopathologist.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has emerged as a minimally invasive technique for evaluating the mediastinum and staging patients with lung cancer. In the...

Vertebral Body Tumor Biopsy: An Expanded Role of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration.

Endobronchial ultrasound has become routinely utilized to improve sampling of mediastinal and hilar lymph nodes in the evaluation of suspected lung cancer. In addition, unconventional uses of this tec...

Accurate and safe mediastinal restaging by combined endobronchial and endoscopic ultrasound-guided needle aspiration performed by single ultrasound bronchoscope.

The aim of this prospective trial was to assess the diagnostic utility of combined endobronchial (EBUS) and endoscopic (EUS) ultrasound-guided needle aspiration by use of a single ultrasound bronchosc...

Intrapulmonary Schwannoma Diagnosed With Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: Case Report.

A 47-year-old woman was referred to our hospital for further examination of a lung tumor. CT of the chest revealed a round, well-defined 2.4-cm nodule in S2, adjacent to right superior lobe bronchus....

Medical and Biotech [MESH] Definitions

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).

Tumors or cancer of the LUNG.

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.

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.

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.

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