Acute PancreatitisORIONNCT01798511
Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)
A study testing Nasogastric Tube Feeding and Conventional Nutritonal Management in people with Acute Pancreatitis, run by University of Auckland, New Zealand at 1 site in New Zealand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Nasogastric Tube Feeding and Conventional Nutritonal Management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Apr 2013to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AP
- Age 18 years or older
- Written informed consent
- Ongoing need for opiates
Who cannot join
- 96 hours after onset of symptoms
- Chronic pancreatitis
- Post-ERCP pancreatitis
- Intraoperative diagnosis
- Pregnancy
- Malignancy
- Received nutrition before randomisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Pancreatitis
- Being tested
- Nasogastric Tube Feeding, Conventional Nutritonal Management
- Keywords
- enteral nutrition, acute pancreatitis, oral food intolerance
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric Tube FeedingProcedure or surgery
A nasogastric tube will be placed into the stomach of patients.
Conventional Nutritonal ManagementOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Nasogastric Tube Feeding |
| 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. Receives: Other: Conventional Nutritonal Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oral food intolerance
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes (4)
Progression of severity
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Pain relapse
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Use of opioids
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Duration of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study start1 Apr 2013 (estimated)
- Primary completion1 Apr 2015 (estimated)
- Study completion1 Apr 2020 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Petrov, University of Auckland, New Zealand
- Investigators
- Max Petrov, MD, MPH, PhD, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798511
- Sponsor's protocol ID
- 13/NTA/9
- Acronym
- ORION
- Status last verified
- Sep 2019
- First submitted
- 13 Feb 2013
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Oral Refeeding Intolerance After Nasogastric Tube Feeding
- ClinicalTrials.gov ID
- NCT01798511
- Acronym / sponsor ID
- ORION / 13/NTA/9
- Conditions
- Acute Pancreatitis
- Keywords
- enteral nutrition, acute pancreatitis, oral food intolerance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- 1 Apr 2013 (estimated)
- Primary completion
- 1 Apr 2015 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasogastric Tube Feeding | Experimental | Procedure: Nasogastric Tube FeedingPatients 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. |
| Conventional Nutritional Management | Active comparator | Other: Conventional Nutritonal ManagementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of AP
- Age 18 years or older
- Written informed consent
- Ongoing need for opiates
Key exclusion criteria (7 listed)
- 96 hours after onset of symptoms
- Chronic pancreatitis
- Post-ERCP pancreatitis
- Intraoperative diagnosis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasogastric Tube FeedingA nasogastric tube will be placed into the stomach of patients. | Procedure or surgery | Nasogastric Tube Feeding |
| Conventional Nutritonal ManagementPatients 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) | Other | Conventional Nutritional Management |
Primary outcome
Incidence of oral food intolerance
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
4 secondary outcomes
Progression of severity
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Pain relapse
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Use of opioids
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Duration of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Petrov, MD, MPH, PhD principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasogastric Tube Feeding and Conventional Nutritonal Management in people with Acute Pancreatitis, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oral food intolerance (time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.