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ISRCTN
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ISRCTN12838218
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ClinicalTrials.gov identifier
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Public title
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Randomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis
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Scientific title
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Acronym
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PANCREAS 2000 ENSAP
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Serial number at source
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PANC/EN/2005/v1
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Study hypothesis
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Null hypothesis: Early enteral nutrition in patients suffering from severe acute pancreatitis does not ameliorate the increased gut permeability associated with disease.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Severe acute pancreatitis
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Participants - inclusion criteria
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Patients 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.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/05/2005
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Anticipated end date
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30/04/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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66
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Interventions
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Group 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.
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Primary outcome measure(s)
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Reduction of proportion of patients with increased gut permeatbility from 80% by half to 40%.
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Secondary outcome measure(s)
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1. 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
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Sources of funding
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Barts and the London NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
Hemant
Kocher
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Address
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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
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City/town
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London
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Zip/Postcode
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EC1M 6BQ
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Country
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United Kingdom
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Sponsor
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Barts and the London NHS Trust (UK)
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Address
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The Royal London Hospital
Whitechapel Road
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City/town
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London
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Zip/Postcode
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E1 1BB
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Country
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United Kingdom
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Date applied
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10/12/2004
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Last edited
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27/04/2009
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Date ISRCTN assigned
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01/03/2005
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