Inoperable oesophageal cancer - stent or percutaneous endoscopically placed gastrostomy (PEG). Randomised trial to compare the risks and benefits of expanding metallic stent and PEG in inoperable oesophageal cancer
| ISRCTN | ISRCTN95850244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95850244 |
| Secondary identifying numbers | N0084096607 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/10/2012
- 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 Mounes Dakkak
Scientific
Scientific
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
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 | 1. Does the early placement of a PEG feeding tube prolong life and/or improve quality of life? 2. Does PEG feeding offer advantages over stent placement? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Oesophageal |
| Intervention | 1. Oesophageal stent 2. PEG Please note that this trial was stopped due to participant recruitment issues. |
| Intervention type | Other |
| Primary outcome measure | Survival and quality of life. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2000 |
| Completion date | 30/06/2003 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 patients for each study arm. |
| Key inclusion criteria | 20 patients for each study arm. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
The North and South Bank Research and Development Consortium (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 |
