Contact information
Type
Scientific
Primary contact
Mr Hemant Kocher
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PANC/EN/2005/v1
Study information
Scientific title
Randomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis
Acronym
PANCREAS 2000 ENSAP
Study hypothesis
Null hypothesis: Early enteral nutrition in patients suffering from severe acute pancreatitis does not ameliorate the increased gut permeability associated with disease.
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
Condition
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
Phase
Drug names
Primary outcome measures
Reduction of proportion of patients with increased gut permeatbility from 80% by half to 40%.
Secondary outcome measures
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
Overall trial start date
01/05/2005
Overall trial end date
30/04/2007
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2005
Recruitment end date
30/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Mary's School Of Medicine & Dentistry at Barts & The London
London
EC1M 6BQ
United Kingdom
Funders
Funder type
Government
Funder name
Barts and the London 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