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

Acute Pancreatitis Clinical Trial

— MIMOSA  

Official title:

Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128478
• Other study ID #: NTX/08/11/107
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 11, 2010
• Last updated: January 5, 2013
• Start date: May 2010
• Est. completion date: April 2012

Study information

• Verified date: January 2013
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Procedure:
• Enteral tube feeding
Nasogastric tube feeding started within 24 h of hospital admission

Locations

Country	Name	City	State
New Zealand	University of Auckland	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

References & Publications (3)

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. Epub 2007 Jun 16. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay		Up to 3 months	No
Secondary	Pain relapse		Up to 3 months	Yes
Secondary	Local and systemic complications		Up to 3 months	No
Secondary	Feeding intolerance		Up to 3 months	Yes
Secondary	Time to solid oral food tolerated		Approx. one week	No
Secondary	Pain-free time		Up to 3 months	No
Secondary	Hospital readmission		Up to 6 months	No
Secondary	Quality of life		Up to 6 months	No
Secondary	Mortality		Up to 6 months	No