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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasogastric Tube Feeding | Procedure | A nasogastric tube will be placed into the stomach of patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of oral food intolerance | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Max Petrov, MD, MPH, PhD | University of Auckland, New Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Auckland | Auckland | New Zealand |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| Conventional Nutritonal Management | Other | 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) |
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| 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 |