Acute Pancreatitis
Conditions
Keywords
enteral nutrition, acute pancreatitis, oral food intolerance
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.
Interventions
PROCEDURENasogastric Tube Feeding
A nasogastric tube will be placed into the stomach of patients.
OTHERConventional Nutritonal Management
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)
Sponsors
University of Auckland, New Zealand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AP * Age 18 years or older * Written informed consent * Ongoing need for opiates
Exclusion criteria
* 96 hours after onset of symptoms * Chronic pancreatitis * Post-ERCP pancreatitis * Intraoperative diagnosis * Pregnancy * Malignancy * Received nutrition before randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of oral food intolerance | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
New Zealand
Outcome results
None listed