Multi centre randomised prospective trial of duodenal stenting versus surgical gastrojejunostomy for palliative relief of gastric outlet obstruction secondary to inoperable peri-ampullary cancers

ISRCTN	ISRCTN52981264
DOI	https://doi.org/10.1186/ISRCTN52981264
Secondary identifying numbers	N0256107988

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Robert Hutchins
Scientific

University Department of Surgery
The Royal Free & University Medical School
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Which method of gastric bypass offers the best palliation with lowest cost and least mortality and morbidity?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Gastric bypass
Intervention	Patients randomised to receive duodenal stenting or surgical bypass. Followed up until death with analysis of morbidity, mortality, survival, cost, readmission rates, palliation of symptoms and quality of life.
Intervention type	Procedure/Surgery
Primary outcome measure	30 Day mortality, morbidity, cost, quality of life, survival after treatment, recurrent hospital admissions and reasons, successful placement of stents, return to nutrition and level of return to nutrition.
Secondary outcome measures	Not provided at time of registration
Overall study start date	03/01/2002
Completion date	03/01/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	70
Key inclusion criteria	35 patients in each group.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	03/01/2002
Date of final enrolment	03/01/2004

University Department of Surgery

London
NW3 2QG
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Hospital/treatment centre

The Royal Free Hampstead NHS Trust (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	01/06/2007		Yes	No