Laparoscopic gastrojejunostomy versus self expanding metal stent for malignant gastric outlet obstruction: a prospective randomised trial

ISRCTN	ISRCTN03084082
DOI	https://doi.org/10.1186/ISRCTN03084082
Secondary identifying numbers	N0547102224

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Michael PN Lewis
Scientific

Consultant Surgeon
General Surgery
Norfolk and Norwich Hospital
Brunswick Road
Norwich
NR1 3SR
United Kingdom

Phone	+44 (0)1603 287583
Email	karen.turner@nnuh.nhs.uk

Study design	Prospective randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Gastrojejunostomy
Intervention	Laparoscopic gastrojejunostomy versus self expanding metal stent for malignant gastric outlet obstruction
Intervention type	Procedure/Surgery
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	10/07/2001
Completion date	10/07/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60 anticipated. Added July 2008: 27 patients enrolled.
Key inclusion criteria	20 per year
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/07/2001
Date of final enrolment	10/07/2004

Consultant Surgeon

Norwich
NR1 3SR
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2006		Yes	No