Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Dr Robert Rintoul


Contact details

Papworth Hospital NHS Foundation Trust
Papworth Everard
CB23 8RE
United Kingdom
+44 (0)1480 364342

Additional identifiers

EudraCT number number


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



Study hypothesis

The hypothesis is that endobronchial/endoscopic staging is as accurate as surgical staging.

More details can be found at:
Protocol can be found at:

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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Non small cell lung cancer


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



Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


Participant exclusion criteria

1. Evidence of metastatic spread
2. Concurrent malignancy
3. Uncorrected coagulopathy
4. Inability to consent

Recruitment start date


Recruitment end date



Countries of recruitment

Belgium, Denmark, Germany, United Kingdom

Trial participating centre

Papworth Hospital NHS Foundation Trust
CB23 8RE
United Kingdom

Sponsor information


Papworth Hospital NHS Foundation Trust (UK)

Sponsor details

Papworth Everard
CB23 3RE
United Kingdom
+44 (0)1480 364451

Sponsor type




Funder type


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


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

Results - basic reporting

Publication summary

2012 results in:
2013 health economics analysis in:

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

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.