Contact information
Type
Scientific
Primary contact
Prof Andreas Adam
ORCID ID
Contact details
Department of Radiology
F01 Lambeth Wing
St Thomas's Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 5550
andy.adam@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013160111
Study information
Scientific title
Acronym
Study hypothesis
Whether a valve in oesophageal stent design is beneficial?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Dysphagia scores, barium reflux.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
27/01/2005
Overall trial end date
27/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Randomised between stents with no valve but prescribed Omeprazole and stent with valve. Approx. 50 patients.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Pregnant women
2. Patients under 18 years of age
3. Patients unfit for stent insertion
Recruitment start date
27/01/2005
Recruitment end date
27/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Radiology
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18410607
Publication citations
-
Results
Sabharwal T, Gulati MS, Fotiadis N, Dourado R, Botha A, Mason R, Adam A, Randomised comparison of the FerX Ella antireflux stent and the ultraflex stent: proton pump inhibitor combination for prevention of post-stent reflux in patients with esophageal carcinoma involving the esophago-gastric junction., J. Gastroenterol. Hepatol., 2008, 23, 5, 723-728, doi: 10.1111/j.1440-1746.2008.05396.x.