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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Robert Rintoul
Scientific

Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 8RE
United Kingdom

Phone +44 (0)1480 364342
Email robert.rintoul@papworth.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised, controlled trial of surgical staging with endobronchial and endoscopic ultrasound for assessment of the mediastinum in lung cancer
Study acronymASTER
Study objectivesThe 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) studiedNon small cell lung cancer
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measureSensitivity of Endobronchial and Endoscopic Ultrasound (EBUS/EUS)
Secondary outcome measures1. Utility
2. Number of surgical procedures that can be avoided if EBUS/EUS is used
Overall study start date01/12/2007
Completion date30/11/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants142
Total final enrolment241
Key inclusion criteria1. 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 criteria1. Evidence of metastatic spread
2. Concurrent malignancy
3. Uncorrected coagulopathy
4. Inability to consent
Date of first enrolment01/12/2007
Date of final enrolment30/11/2010

Locations

Countries of recruitment

  • Belgium
  • Denmark
  • England
  • Germany
  • United Kingdom

Study participating centre

Papworth Hospital NHS Foundation Trust
Cambridge
CB23 8RE
United Kingdom

Sponsor information

Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Papworth Everard
Cambridge
CB23 3RE
England
United Kingdom

Phone +44 (0)1480 364451
Email alistair.grant@papworth.nhs.uk
Website http://www.papworthpeople.com/
ROR logo "ROR" https://ror.org/01qbebb31

Funders

Funder type

Government

Health Technology Assessment Programme
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.