MIld to MOderate Acute Pancreatitis: Early naSogastric Tube Feeding Compared With pAncreas Rest (MIMOSA)

NCT01128478 | Completed Phase 2 DMC

• 1 other identifier: NTX/08/11/107
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

Acute pancreatitis; Enteral nutrition; Pancreas rest

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Up to 3 months

Secondary Outcomes (8)

• Pain relapse

  Up to 3 months

• Local and systemic complications

  Up to 3 months

• Feeding intolerance

  Up to 3 months

• Time to solid oral food tolerated

  Approx. one week

• Pain-free time

  Up to 3 months

Study Arms (2)

Enteral tube feeding

OTHER

Nasogastric tube feeding started within 24 h of hospital admission

Procedure: Enteral tube feeding

Nil-per-mouth regimen

NO INTERVENTION

Conventional management

Interventions

Enteral tube feeding PROCEDURE

Nasogastric tube feeding started within 24 h of hospital admission

Enteral tube feeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (1)

University of Auckland

Auckland, New Zealand

Location

Related Publications (4)

• 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.

  PMID: 17686077 BACKGROUND

• 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.

  PMID: 17573797 BACKGROUND

• 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.

  PMID: 18331767 BACKGROUND

• 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.

  PMID: 23340042 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Max Petrov, MD, MPH (Epi)

  Universioty of Auckland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 24, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

NZ (1)