Condition category
Digestive System
Date applied
10/12/2004
Date assigned
01/03/2005
Last edited
23/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Barts and the London NHS Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes