Oesophageal stents with anti-reflux valve for treatment of tumour of the oesophageal junction
| ISRCTN | ISRCTN83742179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83742179 |
| Protocol serial number | N0226127789 |
| Sponsor | Department of Health |
| Funder | South Manchester University Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Development of gastro-oesophageal reflux symptoms requiring treatment |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
