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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01128478




Registration number
NCT01128478
Ethics application status
Date submitted
11/05/2010
Date registered
24/05/2010
Date last updated
8/01/2013

Titles & IDs
Public title
MIld to MOderate Acute Pancreatitis: Early naSogastric Tube Feeding Compared With pAncreas Rest (MIMOSA)
Scientific title
Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
Secondary ID [1] 0 0
NTX/08/11/107
Universal Trial Number (UTN)
Trial acronym
MIMOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pancreatitis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Enteral tube feeding

Other: Enteral tube feeding - Nasogastric tube feeding started within 24 h of hospital admission

No intervention: Nil-per-mouth regimen - Conventional management


Treatment: Surgery: Enteral tube feeding
Nasogastric tube feeding started within 24 h of hospital admission
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Length of hospital stay
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [1] 0 0
Pain relapse
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [2] 0 0
Local and systemic complications
Timepoint [2] 0 0
Up to 3 months
Secondary outcome [3] 0 0
Feeding intolerance
Timepoint [3] 0 0
Up to 3 months
Secondary outcome [4] 0 0
Time to solid oral food tolerated
Timepoint [4] 0 0
Approx. one week
Secondary outcome [5] 0 0
Pain-free time
Timepoint [5] 0 0
Up to 3 months
Secondary outcome [6] 0 0
Hospital readmission
Timepoint [6] 0 0
Up to 6 months
Secondary outcome [7] 0 0
Quality of life
Timepoint [7] 0 0
Up to 6 months
Secondary outcome [8] 0 0
Mortality
Timepoint [8] 0 0
Up to 6 months

Eligibility
Key inclusion criteria
* diagnosis of acute pancreatitis
* age 18 years or older
* written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* > 96 hours after onset of symptoms
* > 24 hours after hospital admission
* organ failure by the time of randomization
* infectious complications before randomization
* received artificial nutrition before randomization
* previously enrolled into the trial
* chronic pancreatitis
* post-ERCP pancreatitis
* intraoperative diagnosis of acute pancreatitis
* pregnancy
* malignancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute pancreatitis. The study hypothesis is that early administered enteral tube feeding might reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute pancreatitis.
Trial website
https://clinicaltrials.gov/study/NCT01128478
Trial related presentations / publications
Petrov MS. Enteral nutrition: goody or good-for-nothing in acute pancreatitis? Am J Gastroenterol. 2007 Aug;102(8):1828-9; author reply 1829-30. doi: 10.1111/j.1572-0241.2007.01361.x. No abstract available.
Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. doi: 10.1111/j.1572-0241.2007.01357.x. Epub 2007 Jun 16.
Petrov MS. To feed or not to feed early in acute pancreatitis: still depend on severity? Clin Nutr. 2008 Apr;27(2):317-8. doi: 10.1016/j.clnu.2008.01.011. Epub 2008 Mar 10. No abstract available.
Petrov MS, McIlroy K, Grayson L, Phillips AR, Windsor JA. Early nasogastric tube feeding versus nil per os in mild to moderate acute pancreatitis: a randomized controlled trial. Clin Nutr. 2013 Oct;32(5):697-703. doi: 10.1016/j.clnu.2012.12.011. Epub 2012 Dec 31.
Public notes

Contacts
Principal investigator
Name 0 0
Max Petrov, MD, MPH (Epi)
Address 0 0
Universioty of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01128478