Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes