NCT01798511

Brief Summary

Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of surgeons and gastroenterologists throughout the world. The high rate of pain relapse after oral refeeding contributes to high consumption of healthcare resources and prolonged hospital stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The potential beneficial effects of enteral tube feeding include induction of postprandial gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the risk of pain relapse, thereby shortening length of hospital stay and reducing cost of treatment. The primary endpoint of the ORION trial will be the incidence of oral food intolerance. All eligible AP patients will be randomly allocated to either the Early Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of hospital admission.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

February 13, 2013

Last Update Submit

September 24, 2019

Conditions

Acute Pancreatitis

Keywords

enteral nutritionacute pancreatitisoral food intolerance

Outcome Measures

Primary Outcomes (1)

  • Incidence of oral food intolerance

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcomes (4)

  • Progression of severity

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • Pain relapse

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • Use of opioids

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • Duration of hospital stay

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

Nasogastric Tube Feeding

EXPERIMENTAL

Patients who are to have NTF will receive enteral nutrition within 6 hours after randomisation via a nasogastric tube placed into the stomach. A commercially available low fat semi-elemental feed (Peptisorb®, Nutricia Clinical NZ) will be used. The caloric target will be 2000 kcal per day. Enteral tube feeding will be commenced at a rate of 30 mL/h and increased gradually until 100 mL/h over 24-48 h.

Procedure: Nasogastric Tube Feeding

Conventional Nutritional Management

ACTIVE COMPARATOR

Patients who are to have CNM will be on nil-by-mouth regimen until they either develop signs of severe AP (in which case enteral tube feeding will be introduced) or the signs of AP mitigate,in which case clear liquids (as tolerated) followed by oral food (as tolerated) will be introduced.

Other: Conventional Nutritonal Management

Interventions

Nasogastric Tube FeedingPROCEDURE

A nasogastric tube will be placed into the stomach of patients.

Nasogastric Tube Feeding
Conventional Nutritonal ManagementOTHER

Patients who are to have CNM will be on nil-by-mouth regimen until they either develop signs of severe AP (in which case nasojejunal tube feeding will be introduced) or the signs of AP mitigate (in which case clear liquids (as tolerated) followed by oral food (as tolerated) will be introduced)

Conventional Nutritional Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of AP
  • Age 18 years or older
  • Written informed consent
  • Ongoing need for opiates

You may not qualify if:

  • hours after onset of symptoms
  • Chronic pancreatitis
  • Post-ERCP pancreatitis
  • Intraoperative diagnosis
  • Pregnancy
  • Malignancy
  • Received nutrition before randomisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Auckland

Auckland, New Zealand

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Max Petrov, MD, MPH, PhD

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Dr. Max Petrov

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 26, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2020

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

NZ(1)