Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/07/2008
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

Mr Michael PN Lewis

ORCID ID

Contact details

Consultant Surgeon
General Surgery
Norfolk and Norwich Hospital
Brunswick Road
Norwich
NR1 3SR
United Kingdom
+44 (0)1603 287583
karen.turner@nnuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0547102224

Study information

Scientific title

Acronym

Study hypothesis

1. To investigate whether self expanding metal stents are comparable to laparoscopic gastrojejunostomy in treating malignant gastric outlet obstruction
2. To evaluate the cost effectiveness of both treatments
3. To examine the effects of both treatments on quality of life

Ethics approval

Not provided at time of registration

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Surgery: Gastrojejunostomy

Intervention

Laparoscopic gastrojejunostomy versus self expanding metal stent for malignant gastric outlet obstruction

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/07/2001

Overall trial end date

10/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

20 per year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 anticipated. Added July 2008: 27 patients enrolled.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/07/2001

Recruitment end date

10/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Surgeon
Norwich
NR1 3SR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16362479

Publication citations

  1. Results

    Mehta S, Hindmarsh A, Cheong E, Cockburn J, Saada J, Tighe R, Lewis MP, Rhodes M, Prospective randomized trial of laparoscopic gastrojejunostomy versus duodenal stenting for malignant gastric outflow obstruction., Surg Endosc, 2006, 20, 2, 239-242, doi: 10.1007/s00464-005-0130-9.

Additional files

Editorial Notes