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ISRCTN
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ISRCTN78960892
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ClinicalTrials.gov identifier
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Public title
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Valved oesophageal stents in patients with oesophageal carcinoma.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013160111
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Study hypothesis
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Whether a valve in oesophageal stent design is beneficial?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer: Oesophageal
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Participants - inclusion criteria
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Randomised between stents with no valve but prescribed Omeprazole and stent with valve. Approx. 50 patients.
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Participants - exclusion criteria
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1. Pregnant women
2. Patients under 18 years of age
3. Patients unfit for stent insertion
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Anticipated start date
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27/01/2005
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Anticipated end date
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27/01/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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50
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Interventions
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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.
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Primary outcome measure(s)
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Dysphagia scores, barium reflux.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Prof
Andreas
Adam
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Address
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Department of Radiology
F01 Lambeth Wing
St Thomas's Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 5550
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Fax
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+44 (0)20 7188 5454
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Email
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andy.adam@kcl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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03/10/2005
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Date ISRCTN assigned
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30/09/2005
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