A randomised, controlled trial of surgical staging with endobronchial and endoscopic ultrasound for assessment of the mediastinum in lung cancer
| ISRCTN | ISRCTN97311620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97311620 |
| ClinicalTrials.gov number | NCT00432640 |
| Secondary identifying numbers | HTA 06/302/216; P01198 |
- Submission date
- 13/06/2007
- Registration date
- 14/06/2007
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-different-ways-of-checking-lymph-nodes-in-the-chest-for-non-small-cell-lung-cancer
Contact information
Scientific
Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 8RE
United Kingdom
| Phone | +44 (0)1480 364342 |
|---|---|
| robert.rintoul@papworth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised, controlled trial of surgical staging with endobronchial and endoscopic ultrasound for assessment of the mediastinum in lung cancer |
| Study acronym | ASTER |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2007 |
| Completion date | 30/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 142 |
| Total final enrolment | 241 |
| Key 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. |
| Key exclusion criteria | 1. Evidence of metastatic spread 2. Concurrent malignancy 3. Uncorrected coagulopathy 4. Inability to consent |
| Date of first enrolment | 01/12/2007 |
| Date of final enrolment | 30/11/2010 |
Locations
Countries of recruitment
- Belgium
- Denmark
- England
- Germany
- United Kingdom
Study participating centre
CB23 8RE
United Kingdom
Sponsor information
Hospital/treatment centre
Papworth Everard
Cambridge
CB23 3RE
England
United Kingdom
| Phone | +44 (0)1480 364451 |
|---|---|
| alistair.grant@papworth.nhs.uk | |
| Website | http://www.papworthpeople.com/ |
"ROR" |
https://ror.org/01qbebb31 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No | |
| Other publications | health economics analysis | 01/07/2014 | Yes | No | |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
07/07/2016: Plain English summary added.
11/05/2009: the following changes were made to the trial record:
1. The acronym has been changed from MEDUSA to ASTER.
2. The overall trial start and end dates were changed from 01/04/2007 and 31/03/2009 to 01/12/2007 and 30/11/2010, respectively.
