| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN78960892 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0013160111 |
| Public title | Valved oesophageal stents in patients with oesophageal carcinoma. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Oesophageal |
| Study hypothesis | Whether a valve in oesophageal stent design is beneficial? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Randomised between stents with no valve but prescribed Omeprazole and stent with valve. Approx. 50 patients. |
| Participants - exclusion criteria | 1. Pregnant women
2. Patients under 18 years of age
3. Patients unfit for stent insertion |
| Patient information material |
|
| Anticipated start date | 27/01/2005 |
| Anticipated end date | 27/01/2006 |
| Status of trial | Completed |
| Target number of participants | 50 |
| Interventions | 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.
|
| Primary outcome measure(s) | Dysphagia scores, barium reflux. |
| Secondary outcome measure(s) | See Primary outcome measures |
| Sources of funding | Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof Andreas Adam |
| Contact details | Department of Radiology
F01 Lambeth Wing
St Thomas's Hospital
Lambeth Palace Road
London
United Kingdom
SE1 7EH |
| Contact telephone | +44 (0)20 7188 5550 |
| Contact fax | +44 (0)20 7188 5454 |
| Contact email | andy.adam@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN78960892 |
| Date last extracted from ISRCTN register | 17/04/2008 |
