Valved oesophageal stents in patients with oesophageal carcinoma.

ISRCTN ISRCTN78960892
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

Department of Radiology
F01 Lambeth Wing
St Thomas's Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone +44 (0)20 7188 5550
Email andy.adam@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesWhether a valve in oesophageal stent design is beneficial?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOesophageal cancer
InterventionFollowing 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 typeOther
Primary outcome measureDysphagia scores, barium reflux.
Secondary outcome measuresNot provided at time of registration
Overall study start date27/01/2005
Completion date27/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteriaRandomised between stents with no valve but prescribed Omeprazole and stent with valve. Approx. 50 patients.
Key exclusion criteria1. Pregnant women
2. Patients under 18 years of age
3. Patients unfit for stent insertion
Date of first enrolment27/01/2005
Date of final enrolment27/01/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Radiology
London
SE1 7EH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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