Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Oral Refeeding Intolerance After Nasogastric Tube Feeding

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Procedure: Nasogastric Tube Feeding
* Other: Conventional Nutritonal Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasogastric Tube Feeding<br>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<br>* A nasogastric tube will be placed into the stomach of patients.<br>|
| Active Comparator: Conventional Nutritional Management<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enteral nutrition, acute pancreatitis, oral food intolerance