Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)

Acute Pancreatitis Clinical Trial

— ORION  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01798511
• Other study ID #: 13/NTA/9
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2013
• Est. completion date: April 1, 2020

Study information

• Verified date: September 2019
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Procedure:
• Nasogastric Tube Feeding
A nasogastric tube will be placed into the stomach of patients.

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)

Locations

Country	Name	City	State
New Zealand	University of Auckland	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of oral food intolerance		Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary	Progression of severity		Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary	Pain relapse		Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary	Use of opioids		Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary	Duration of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 3 weeks