Randomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis

ISRCTN ISRCTN12838218
DOI https://doi.org/10.1186/ISRCTN12838218
Secondary identifying numbers PANC/EN/2005/v1
Submission date
10/12/2004
Registration date
01/03/2005
Last edited
23/04/2015
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Hemant Kocher
Scientific

Department of Health National Clinician Scientist
Senior Lecturer
Tumour Biology Laboratory
Cancer Research UK Clinical Centre
Queen Mary's School Of Medicine & Dentistry at Barts & The London
John Vane Science Centre
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRandomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis
Study acronymPANCREAS 2000 ENSAP
Study objectivesNull hypothesis: Early enteral nutrition in patients suffering from severe acute pancreatitis does not ameliorate the increased gut permeability associated with disease.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSevere acute pancreatitis
InterventionGroup one: Enteral nutrition via nasogastric/nasojejunal tube, or sip feed, composition as stratified for each centre. To start immediately after randomisation.

Group two: 'Standard' fluid replacement, oral or via intravenous line, composition as stratified for each centre.

Updated 23/04/2015: the trial did not start due to lack of funding.
Intervention typeProcedure/Surgery
Primary outcome measureReduction of proportion of patients with increased gut permeatbility from 80% by half to 40%.
Secondary outcome measures1. Reduction in persistent organ failure (3 days) from 35% to 15%
2. Complications (with specific emphasis on infective complications).
3. Length of hospital/ICU stay
4. Return of normal GI function
5. Markers of intestinal ischaemia (Intestinal fatty acid binding protein) and other markers of gut permeability (endocAb), immune/inflammatory response
Overall study start date01/05/2005
Completion date30/04/2007
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants66
Key inclusion criteriaPatients aged 18 or over with a proven diagnosis of acute pancreatitis (pain and raised enzymes or computed tomography [CT] evidence) together with systemic inflammatory response syndrome (SIRS) or organ failure (Marshall score 2 or more for any organ system except liver, or Atlanta criteria) present for 24 hours or more, and within 72 hours of onset of symptoms.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/05/2005
Date of final enrolment30/04/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queen Mary's School Of Medicine & Dentistry at Barts & The London
London
EC1M 6BQ
United Kingdom

Sponsor information

Barts and the London NHS Trust (UK)
Hospital/treatment centre

The Royal London Hospital
Whitechapel Road
London
E1 1BB
England
United Kingdom

ROR logo "ROR" https://ror.org/00b31g692

Funders

Funder type

Government

Barts and the London NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan