Contact information
Type
Scientific
Primary contact
Dr Hans Ulrich Laasch
ORCID ID
Contact details
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 6235
hansulrich.laasch@smuht.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0226127789
Study information
Scientific title
Acronym
Study hypothesis
To establish whether there is any difference in the performance of two CE-marked, commercially available self expanding oesophageal stents.
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
Condition
Cancer: Oesophageal
Intervention
Please note that this trial was stopped as the devices to be used were no longer available.
All patients will have stents inserted according to integrated care pathway, the only difference from standard procedure will be formal randomisation from a schedule provided by medical statistics rather than random stent allocation.
CE-marked, commercially available self expanding oesophageal stent 1 vs CE-marked, commercially available self expanding oesophageal stent 2.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Development of gastro-oesophageal reflux symptoms requiring treatment
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2003
Overall trial end date
01/09/2004
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
25 patients in each arm. 50 consecutive patients to be recruited after a positive decision for stent insertion has been made - all patients with a tumour site at or extending to the gastro-oesophageal (GO)-junction
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2003
Recruitment end date
01/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Manchester University Hospitals NHS Trust (UK)
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