Clinical trial NCT01128478: MIld to MOderate Acute Pancreatitis: Early naSogastric Tube Feeding Compared With pAncreas Rest (MIMOSA)
Official title: Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Pancreatitis
Keywords: Acute pancreatitis
Enteral nutrition
Pancreas rest
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* diagnosis of acute pancreatitis
* age 18 years or older
* written informed consent

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

Primary outcomes:
measure: Length of hospital stay
timeFrame: Up to 3 months
Secondary outcomes:
measure: Pain relapse
timeFrame: Up to 3 months
measure: Local and systemic complications
timeFrame: Up to 3 months
measure: Feeding intolerance
timeFrame: Up to 3 months
measure: Time to solid oral food tolerated
timeFrame: Approx. one week
measure: Pain-free time
timeFrame: Up to 3 months
measure: Hospital readmission
timeFrame: Up to 6 months
measure: Quality of life
timeFrame: Up to 6 months
measure: Mortality
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
affiliation: Universioty of Auckland
name: Max Petrov, MD, MPH (Epi)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.