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
Protocol serial number	PANC/EN/2005/v1
Sponsor	Barts and the London NHS Trust (UK)
Funder	Barts and the London NHS Trust (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis
Study acronym	PANCREAS 2000 ENSAP
Study objectives	Null 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) studied	Severe acute pancreatitis
Intervention	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. Updated 23/04/2015: the trial did not start due to lack of funding.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Reduction of proportion of patients with increased gut permeatbility from 80% by half to 40%.
Key secondary outcome measure(s)	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
Completion date	30/04/2007
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	66
Key inclusion criteria	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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2005
Date of final enrolment	30/04/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Queen Mary's School Of Medicine & Dentistry at Barts & The London

London
EC1M 6BQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan