BOOST: Bronchoscopic or oesophageal ultrasound as a first test for the diagnosis and staging of lung cancer
Lead Research Organisation:
University College London
Department Name: UNLISTED
Abstract
The best treatment for lung cancer is surgery. However, if disease has spread outside the lung then surgery is not recommended and therefore determining whether lung cancer has spread is a critical step in management.
Unfortunately in 80% of lung cancer cases, the disease will have already spread outside the lungs. The most common place that the disease first spreads to, is glands in the chest between the lungs (mediastinum). Currently, however, assessment of the mediastinum requires several scans and often an operation. This is time consuming, expensive, technically difficult and often inaccurate.
A new diagnostic technology called endoscopic ultrasound uses sound waves to look through the walls of the airways or oesophagus (gullet), enabling direct visualisation and sampling of the mediastinum as a day-case procedure. Sampling the mediastinum provides information on the type of lung cancer and whether it has spread in one investigation. We believe endoscopic ultrasound should be a first diagnostic investigation (after a CT scan) in patients referred with suspected lung cancer. We envisage that this will be more accurate, take less time and by preventing other scans and operations will represent significant cost savings. This improved patient pathway can be implemented in cancer centres around the country.
Unfortunately in 80% of lung cancer cases, the disease will have already spread outside the lungs. The most common place that the disease first spreads to, is glands in the chest between the lungs (mediastinum). Currently, however, assessment of the mediastinum requires several scans and often an operation. This is time consuming, expensive, technically difficult and often inaccurate.
A new diagnostic technology called endoscopic ultrasound uses sound waves to look through the walls of the airways or oesophagus (gullet), enabling direct visualisation and sampling of the mediastinum as a day-case procedure. Sampling the mediastinum provides information on the type of lung cancer and whether it has spread in one investigation. We believe endoscopic ultrasound should be a first diagnostic investigation (after a CT scan) in patients referred with suspected lung cancer. We envisage that this will be more accurate, take less time and by preventing other scans and operations will represent significant cost savings. This improved patient pathway can be implemented in cancer centres around the country.
Technical Summary
BOOST: Bronchoscopic or Oesophageal ultrasound for lung cancer staging
A randomised controlled trial of endobronchial ultrasound or endoscopic ultrasound as a first test in the diagnosis and staging of non-small cell lung cancer
Background
Lung cancer is the leading cause of cancer death in the UK. The staging of lung cancer is a critical step which determines treatment options but currently it requires an average of 45 days, is expensive and inaccurate. 90% of lung cancer patients in the UK have inoperable cancer. Therefore establishing the diagnosis and the presence of metastatic spread with a single test would shorten the patient journey and reduce the need for expensive further tests, such as PET and mediastinoscopy. Having a first line test that diagnoses mediastinal metastasis with accuracy may also reduce inappropriate operations where current techniques fail to confirm tumour spread.
Hypothesis
EUS (endoscopic ultrasound) or EBUS-FNA (endobronchial ultrasound guided fine needle aspiration) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment, a reduction in the number of PET scans, mediastinoscopies and futile thoracotomies and lower NHS healthcare costs.
Methods
Study Design
Baseline data will be collected from 200 retrospective patients from 5 North London Cancer Network Hospitals in order to confirm current practice. Prospective data will be collected from consecutive patients suspected of lung cancer in 3 centres. Patients with extra-thoracic disease amenable to biopsy or pleural effusions are excluded. The remaining patients are randomised to control or active arms. The control arm will consist of 84 patients being managed according to local clinical practice. Eighty-four patients in the active arm will undergo EUS or EBUS-FNA as a first test after CT scan.
Endpoints
The primary endpoint is the number of days from first outpatient appointment to treatment start.
The secondary endpoints are:
i. The healthcare costs of diagnosing and staging lung cancer
ii. The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer
iii. The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan
iv. The number of futile thoracotomies
By demonstrating that EBUS/EUS as a first test after CT scan is effective in diagnosing and staging lung cancer, we believe, will result in a change in the staging algorithm for lung cancer.
A randomised controlled trial of endobronchial ultrasound or endoscopic ultrasound as a first test in the diagnosis and staging of non-small cell lung cancer
Background
Lung cancer is the leading cause of cancer death in the UK. The staging of lung cancer is a critical step which determines treatment options but currently it requires an average of 45 days, is expensive and inaccurate. 90% of lung cancer patients in the UK have inoperable cancer. Therefore establishing the diagnosis and the presence of metastatic spread with a single test would shorten the patient journey and reduce the need for expensive further tests, such as PET and mediastinoscopy. Having a first line test that diagnoses mediastinal metastasis with accuracy may also reduce inappropriate operations where current techniques fail to confirm tumour spread.
Hypothesis
EUS (endoscopic ultrasound) or EBUS-FNA (endobronchial ultrasound guided fine needle aspiration) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment, a reduction in the number of PET scans, mediastinoscopies and futile thoracotomies and lower NHS healthcare costs.
Methods
Study Design
Baseline data will be collected from 200 retrospective patients from 5 North London Cancer Network Hospitals in order to confirm current practice. Prospective data will be collected from consecutive patients suspected of lung cancer in 3 centres. Patients with extra-thoracic disease amenable to biopsy or pleural effusions are excluded. The remaining patients are randomised to control or active arms. The control arm will consist of 84 patients being managed according to local clinical practice. Eighty-four patients in the active arm will undergo EUS or EBUS-FNA as a first test after CT scan.
Endpoints
The primary endpoint is the number of days from first outpatient appointment to treatment start.
The secondary endpoints are:
i. The healthcare costs of diagnosing and staging lung cancer
ii. The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer
iii. The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan
iv. The number of futile thoracotomies
By demonstrating that EBUS/EUS as a first test after CT scan is effective in diagnosing and staging lung cancer, we believe, will result in a change in the staging algorithm for lung cancer.