Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256107988
Study information
Scientific title
Acronym
Study hypothesis
Which method of gastric bypass offers the best palliation with lowest cost and least mortality and morbidity?
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
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
03/01/2002
Overall trial end date
03/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
35 patients in each group.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
70
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
03/01/2002
Recruitment end date
03/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Department of Surgery
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead 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
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18810668
Publication citations
-
Results
Mukherjee S, Kocher HM, Hutchins RR, Bhattacharya S, Abraham AT, Palliative surgical bypass for pancreatic and peri-ampullary cancers., J Gastrointest Cancer, 2007, 38, 2-4, 102-107, doi: 10.1007/s12029-008-9020-4.