Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION) (ORION)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Procedure: Nasogastric Tube Feeding; Other: Conventional Nutritonal Management

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • University of Auckland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Nasogastric Tube Feeding; A nasogastric tube will be placed into the stomach of patients.
Active Comparator: Conventional Nutritional 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.	Other: 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 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)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Auckland, New Zealand
• Investigators: Principal Investigator: Max Petrov, MD, MPH, PhD, University of Auckland, New Zealand

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2013
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: acute pancreatitis; enteral nutrition; oral food intolerance
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 13/NTA/9