Condition category
Cancer
Date applied
13/06/2007
Date assigned
14/06/2007
Last edited
07/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
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
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 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

01/12/2007

Overall trial end date

30/11/2010

Reason abandoned

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

http://www.papworthpeople.com/

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

Results - basic reporting

Publication summary

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

  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.