Surgical Versus Non-surgical Staging of Lung Cancer
Status: | Terminated |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 5/18/2018 |
Start Date: | September 2009 |
End Date: | July 2011 |
A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer
About half of all lung cancers are caught after they have spread to nearby lymph nodes. Lymph
nodes are small glands found throughout the body that remove bacteria and foreign particles
(part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the
laboratory for testing. Biopsy results can determine if the cancer has spread (metastases)
and to determine the best treatment for a patient with lung cancer.
The purpose of this study is to develop a better way to detect lung cancer earlier before it
spreads. This study compares the traditional mediastinoscopy/thoracoscopy surgery with the
newer combined Endobronchial Ultrasound (EBUS) and Endoscopic Ultrasound (EUS) -guided fine
needle aspiration (FNA) to see if either is better for this purpose. Traditional medical
practice is to surgically open the chest and biopsy suspicious lymph nodes (called a
mediastinoscopy/thoracoscopy). Some medical centers have already started combining the use of
EUS plus EBUS as a standard practice for performing needle biopsy of lymph nodes in the chest
to stage and treat lung cancer.
Volunteers for this study have been diagnosed with known or suspected lung cancer, and will
receive one of two choices to determine if their cancer has spread:
1. Traditional Surgical Mediastinoscopy/Thoracoscopy Mediastinoscopy is a surgical
procedure that allows physicians to view areas of the chest(including the heart,
vessels, lymph nodes, trachea, esophagus, and thymus). An endotracheal (within the
trachea) tube is inserted followed by a small incision (cut) in the chest. A
mediastinoscope is inserted through the incision to see the organs inside the
mediastinum and to collect tissue samples. Mediastinoscopy can be used to detect or
stage cancer.
Thoracoscopy is a surgical procedure that involves insertion of a thorascope through a
very small incision in the chest wall. A thorascope is a thin, tube-like instrument with
a light and lens which usually has a tool for removing tissue. This makes it possible to
examine the lungs or other structures in the chest cavity, without making a large
incision.
2. EBUS combined with EUS-guided FNA EUS involves the use of a special endoscope fitted
with an ultrasound processor at its tip. During EUS, images of surrounding lymph nodes
can be obtained and a small needle can be guided through the esophagus into suspicious
nodes to biopsy lymph nodes in the chest. Other research studies have shown that using
EUS to guide needle biopsy of lymph nodes in the chest is equally if not more accurate
than surgical biopsy. However, use of EUS for needle biopsy can limit what is seen by
the physician and also limit the sampling of lymph nodes in front of the trachea. EBUS
involves the use of a small ultrasound scope that is passed through the opening of the
trachea and into the airways. EBUS combined with EUS is a less invasive procedure that
provides full view of the lymph nodes in the chest area.
nodes are small glands found throughout the body that remove bacteria and foreign particles
(part of the immune system). A biopsy (tissue sample) can then be sent can be sent to the
laboratory for testing. Biopsy results can determine if the cancer has spread (metastases)
and to determine the best treatment for a patient with lung cancer.
The purpose of this study is to develop a better way to detect lung cancer earlier before it
spreads. This study compares the traditional mediastinoscopy/thoracoscopy surgery with the
newer combined Endobronchial Ultrasound (EBUS) and Endoscopic Ultrasound (EUS) -guided fine
needle aspiration (FNA) to see if either is better for this purpose. Traditional medical
practice is to surgically open the chest and biopsy suspicious lymph nodes (called a
mediastinoscopy/thoracoscopy). Some medical centers have already started combining the use of
EUS plus EBUS as a standard practice for performing needle biopsy of lymph nodes in the chest
to stage and treat lung cancer.
Volunteers for this study have been diagnosed with known or suspected lung cancer, and will
receive one of two choices to determine if their cancer has spread:
1. Traditional Surgical Mediastinoscopy/Thoracoscopy Mediastinoscopy is a surgical
procedure that allows physicians to view areas of the chest(including the heart,
vessels, lymph nodes, trachea, esophagus, and thymus). An endotracheal (within the
trachea) tube is inserted followed by a small incision (cut) in the chest. A
mediastinoscope is inserted through the incision to see the organs inside the
mediastinum and to collect tissue samples. Mediastinoscopy can be used to detect or
stage cancer.
Thoracoscopy is a surgical procedure that involves insertion of a thorascope through a
very small incision in the chest wall. A thorascope is a thin, tube-like instrument with
a light and lens which usually has a tool for removing tissue. This makes it possible to
examine the lungs or other structures in the chest cavity, without making a large
incision.
2. EBUS combined with EUS-guided FNA EUS involves the use of a special endoscope fitted
with an ultrasound processor at its tip. During EUS, images of surrounding lymph nodes
can be obtained and a small needle can be guided through the esophagus into suspicious
nodes to biopsy lymph nodes in the chest. Other research studies have shown that using
EUS to guide needle biopsy of lymph nodes in the chest is equally if not more accurate
than surgical biopsy. However, use of EUS for needle biopsy can limit what is seen by
the physician and also limit the sampling of lymph nodes in front of the trachea. EBUS
involves the use of a small ultrasound scope that is passed through the opening of the
trachea and into the airways. EBUS combined with EUS is a less invasive procedure that
provides full view of the lymph nodes in the chest area.
Inclusion Criteria:
- Require either surgical or minimally invasive evaluation (EUS/EBUS) of the mediastinum
- Are medically fit to undergo surgery
- Possess known or suspected non-small cell carcinoma of the lung
- Have had PET/CT scan within 45 days of randomization
- Are eligible for complete mediastinal lymph node dissection at surgery if clinically
indicated (determined at surgery)
Exclusion Criteria:
- Pathologically documented metastatic disease
- History of malignancy within 5 years other than (skin) basal cell carcinoma
- Bulky mediastinal lymphadenopathy defined as lymph node > 2.0 cm in short axis
diameter or contralateral adenopathy or direct invasion mediastinum or great vessels
(T4 disease) or have a malignant pleural effusion.
- Peripheral T1 tumors with radiographically normal mediastinum on PET/CT.
We found this trial at
3
sites
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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