Plain English Summary
Background and study aims
Before undergoing surgery for lung cancer it is crucial to know if the cancer has spread to the lymph nodes in the chest. Currently this is assessed by an operation called a mediastinoscopy. Mediastinoscopy is a surgical procedure to examine the inside of the upper chest between and in front of the lungs (mediastinum), which requires a general anaesthetic and a 2-3 day inpatient stay. The operation is expensive and has a low but not insignificant complication rate. Recently, two minimally invasive screening techniques have been described for sampling lymph nodes by accessing them via the gullet (endoscopic ultrasound guided fine needle aspiration or EUS-FNA) or via the windpipe and main lung passages (endobronchial ultrasound guided transbronchial needle aspiration or EBUS-TBNA). The advantage of these approaches is that they are normally performed under local anaesthetic and sedation as a day case procedure, are cheaper and have virtually no complications. To date there are no studies comparing these two techniques with mediastinoscopy. The aim of this study is to compare the accuracy of cancer staging, cost effectiveness and complications of EBUS/EUS and mediastinoscopy.
Who can participate?
Lung cancer patients who require a mediastinoscopy as part of their routine investigations
What does the study involve?
Participants are randomly allocated to undergo either mediastinoscopy or EBUS/EUS (followed by mediastinoscopy if negative). Biopsy samples from lymph nodes taken by the new techniques are compared with biopsies taken by the surgical technique.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Papworth Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
December 2007 to November 2010
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Robert Rintoul
robert.rintoul@papworth.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Robert Rintoul
ORCID ID
Contact details
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 8RE
United Kingdom
+44 (0)1480 364342
robert.rintoul@papworth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00432640
Protocol/serial number
HTA 06/302/216; P01198
Study information
Scientific title
A randomised, controlled trial of surgical staging with endobronchial and endoscopic ultrasound for assessment of the mediastinum in lung cancer
Acronym
ASTER
Study hypothesis
The hypothesis is that endobronchial/endoscopic staging is as accurate as surgical staging.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/06302216
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/51309/PRO-06-302-216.pdf
Ethics approval
1. The Cambridge 1 Research Ethics Committee (REC) (UK), 29/05/2007
2. Ghent University Hospitals REC (Belgium)
Approval pending for centres in Denmark and Germany. These centres will not be recruiting patients before REC approval has been granted.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non small cell lung cancer
Intervention
Patients will be randomised to have surgical mediastinal staging or staging via Endobronchial and Endoscopic Ultrasound (EBUS/EUS).
EBUS/EUS (the research specific intervention):
This takes place in the bronchoscopy suite as a day case procedure under light sedation. The EBUS/EUS probes are passed down the trachea and oesophagus, respectively, and sequentially. Lymph nodes which have been identified by Computed Tomography (CT) scan (routine practice procedure) are biopsied and sent to the histopathology laboratory for histological analysis. The results of the histology inform the staging result. The staging result determines whether or not a patient is suitable for surgical resection of their lung cancer.
Surgical staging:
The surgical staging is conducted under general anaesthetic. Lymph nodes which have been identified by CT are biopsied and processed as above.
The histology samples will be analysed as soon as they are obtained. In those patients whose staging confirms that they are suitable to proceed to surgical resection, the true negative/false negative status of the histology samples will confirmed. Surgical resection occurs within 14 days of the staging.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Sensitivity of Endobronchial and Endoscopic Ultrasound (EBUS/EUS)
Secondary outcome measures
1. Utility
2. Number of surgical procedures that can be avoided if EBUS/EUS is used
Overall trial start date
01/12/2007
Overall trial end date
30/11/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with a known diagnosis of non small cell lung cancer
2. Patients fit for bronchoscopy, endoscopy and surgical procedures
Male and female adult patients will be recruited - there is no upper age limit.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
142
Participant exclusion criteria
1. Evidence of metastatic spread
2. Concurrent malignancy
3. Uncorrected coagulopathy
4. Inability to consent
Recruitment start date
01/12/2007
Recruitment end date
30/11/2010
Locations
Countries of recruitment
Belgium, Denmark, Germany, United Kingdom
Trial participating centre
Papworth Hospital NHS Foundation Trust
Cambridge
CB23 8RE
United Kingdom
Sponsor information
Organisation
Papworth Hospital NHS Foundation Trust (UK)
Sponsor details
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
+44 (0)1480 364451
alistair.grant@papworth.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22472180
2013 health economics analysis in: http://www.ncbi.nlm.nih.gov/pubmed/24064440
Publication citations
-
Results
Sharples LD, Jackson C, Wheaton E, Griffith G, Annema JT, Dooms C, Tournoy KG, Deschepper E, Hughes V, Magee L, Buxton M, Rintoul RC, Clinical effectiveness and cost-effectiveness of endobronchial and endoscopic ultrasound relative to surgical staging in potentially resectable lung cancer: results from the ASTER randomised controlled trial., Health Technol Assess, 2012, 16, 18, 1-75, iii-iv, doi: 10.3310/hta16180.
-
Health economics analysis
Rintoul RC, Glover MJ, Jackson C, Hughes V, Tournoy KG, Dooms C, Annema JT, Sharples LD, Cost effectiveness of endosonography versus surgical staging in potentially resectable lung cancer: a health economics analysis of the ASTER trial from a European perspective., Thorax, 2014, 69, 7, 679-681, doi: 10.1136/thoraxjnl-2013-204374.