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OpenTrials
Completed

NCT Number: NCT01128478

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

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Auckland

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral tube feeding

Procedure

Nasogastric tube feeding started within 24 h of hospital admission

Primary outcomes

  1. Length of hospital stay

    Time frame: Up to 3 months

Secondary outcomes

  1. Pain relapse

    Time frame: Up to 3 months

  2. Local and systemic complications

    Time frame: Up to 3 months

  3. Feeding intolerance

    Time frame: Up to 3 months

  4. Time to solid oral food tolerated

    Time frame: Approx. one week

  5. Pain-free time

    Time frame: Up to 3 months

  6. Hospital readmission

    Time frame: Up to 6 months

  7. Quality of life

    Time frame: Up to 6 months

  8. Mortality

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Registry information

Official study title

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

Acronym: MIMOSA

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
May 24, 2010
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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