Oesophageal stents with anti-reflux valve for treatment of tumour of the oesophageal junction
| ISRCTN | ISRCTN83742179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83742179 |
| Secondary identifying numbers | N0226127789 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/10/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hans Ulrich Laasch
Scientific
Scientific
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 6235 |
|---|---|
| hansulrich.laasch@smuht.nwest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To establish whether there is any difference in the performance of two CE-marked, commercially available self expanding oesophageal stents. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Oesophageal |
| Intervention | Please note that this trial was stopped as the devices to be used were no longer available. All patients will have stents inserted according to integrated care pathway, the only difference from standard procedure will be formal randomisation from a schedule provided by medical statistics rather than random stent allocation. CE-marked, commercially available self expanding oesophageal stent 1 vs CE-marked, commercially available self expanding oesophageal stent 2. |
| Intervention type | Other |
| Primary outcome measure | Development of gastro-oesophageal reflux symptoms requiring treatment |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2003 |
| Completion date | 01/09/2004 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key inclusion criteria | 25 patients in each arm. 50 consecutive patients to be recruited after a positive decision for stent insertion has been made - all patients with a tumour site at or extending to the gastro-oesophageal (GO)-junction |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
South Manchester University Hospitals NHS Trust (UK)
No information available
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 |
