Condition category
Cancer
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
17/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

  1. 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.

Additional files

Editorial Notes