Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
23/05/2012
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

Mr Robert Hutchins

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes