| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN97311620 |
| Date ISRCTN assigned | 14/06/2007 |
| Local reference number(s) | HTA 06/302/216; P01198 |
| Public title | A randomised, controlled trial of surgical staging with endobronchial and endoscopic ultrasound for assessment of the mediastinum in lung cancer |
| Scientific title |
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| Acronym | MEDUSA |
| Disease/condition/study domain | Non small cell lung cancer |
| Study hypothesis | The hypothesis is that endobronchial/endoscopic staging is as accurate as surgical staging. |
| Design/methodology | A randomised controlled trial |
| Research ethics review | Approved by:
1. The Cambridge 1 Research Ethics Committee (REC) (UK): 29th May 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. |
| Countries of trial | United Kingdom, Denmark, Belgium and Germany |
| Participants - 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. |
| Participants - exclusion criteria | 1. Evidence of metastatic spread
2. Concurrent malignancy
3. Uncorrected coagulopathy
4. Inability to consent |
| Patient information material |
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| Anticipated start date | 01/04/2007 |
| Anticipated end date | 31/03/2009 |
| Status of trial | Ongoing |
| Target number of participants | 142 |
| Interventions | Patients will be randomised to have asurgical 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 Tomograpy (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. |
| Primary outcome measure(s) | Sensitivity of Endobronchial and Endoscopic Ultrasound (EBUS/EUS). |
| Secondary outcome measure(s) | 1. Utility
2. Number of surgical procedures that can be avoided if EBUS/EUS is used |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Papworth Hospital NHS Foundation Trust (UK) |
| Sponsor details | Papworth Everard
Cambridge
United Kingdom
CB23 3RE |
| Sponsor telephone | +44 (0)1480 364451 |
| Sponsor fax | +44 (0)1480 364550 |
| Sponsor email | alistair.grant@papworth.nhs.uk |
| Sponsor website | http://www.papworthpeople.com/ |
| Contact name | Dr Robert Rintoul |
| Contact details | Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
United Kingdom
CB23 8RE |
| Contact telephone | +44 (0)1480 364342 |
| Contact email | robert.rintoul@papworth.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN97311620 |
| Date last extracted from ISRCTN register | 17/04/2008 |
