Randomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitis
ISRCTN | ISRCTN12838218 |
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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
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 design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/05/2005 |
Completion date | 30/04/2007 |
Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Queen Mary's School Of Medicine & Dentistry at Barts & The London
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Sponsor information
Barts and the London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
The Royal London Hospital
Whitechapel Road
London
E1 1BB
England
United Kingdom
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |