Valved oesophageal stents in patients with oesophageal carcinoma.
ISRCTN | ISRCTN78960892 |
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DOI | https://doi.org/10.1186/ISRCTN78960892 |
Secondary identifying numbers | N0013160111 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 17/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andreas Adam
Scientific
Scientific
Department of Radiology
F01 Lambeth Wing
St Thomas's Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Phone | +44 (0)20 7188 5550 |
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andy.adam@kcl.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | |
Study objectives | Whether a valve in oesophageal stent design is beneficial? |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Oesophageal cancer |
Intervention | Following stent insertion, symptomatic reflux may occur, to evaluate whether a valve may prevent this we are conducting this randomised controlled trial comparing valveless stents versus a stent with a valve. All patients entered into this study will have cancer obstructing the lower oesophagus and will be treated with metallic stents projecting into the stomach. There are two groups: One group will receive stents that have a valve that is designed to prevent stomach contents reaching the oesophagus. The other will have stents without a valve. We will look at how well the stents work at stopping reflux, how well they receive dysphagia (difficulty in swallowing) and what the complications are in each group. Subjects will be randomised using a book of random numbers. |
Intervention type | Other |
Primary outcome measure | Dysphagia scores, barium reflux. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 27/01/2005 |
Completion date | 27/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 50 |
Key inclusion criteria | Randomised between stents with no valve but prescribed Omeprazole and stent with valve. Approx. 50 patients. |
Key exclusion criteria | 1. Pregnant women 2. Patients under 18 years of age 3. Patients unfit for stent insertion |
Date of first enrolment | 27/01/2005 |
Date of final enrolment | 27/01/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Radiology
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust (UK)
No information available
Own account
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/05/2008 | Yes | No |