Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)

Not Applicable

Withdrawn

• Conditions: Acute Pancreatitis
• Interventions: Other: Conventional Nutritonal Management; Procedure: Nasogastric Tube Feeding

• Registration Number: NCT01798511
• Lead Sponsor: University of Auckland, New Zealand

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-26
• Study Start: 2013-04-01
• Primary Completion: 2015-04-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Nutritional Management	Conventional 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 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.
Nasogastric Tube Feeding	Nasogastric Tube Feeding	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.

Primary Outcome Measures

Name	Time	Method
Incidence of oral food intolerance	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Auckland; 🇳🇿 Auckland, New Zealand