Oesophageal stents with anti-reflux valve for treatment of tumour of the oesophageal junction

ISRCTN ISRCTN83742179
DOI https://doi.org/10.1186/ISRCTN83742179
Secondary identifying numbers N0226127789
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
19/10/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hans Ulrich Laasch
Scientific

South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone +44 (0)161 291 6235
Email hansulrich.laasch@smuht.nwest.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo establish whether there is any difference in the performance of two CE-marked, commercially available self expanding oesophageal stents.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer: Oesophageal
InterventionPlease 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 typeOther
Primary outcome measureDevelopment of gastro-oesophageal reflux symptoms requiring treatment
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2003
Completion date01/09/2004
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants50
Key inclusion criteria25 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2003
Date of final enrolment01/09/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

South Manchester University Hospitals NHS Trust (UK)

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