Acute PancreatitisPICTORNCT01728896
Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)
A study of Acute Pancreatitis, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pancreatitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Dec 2013to 1 Jun 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of acute pancreatitis
- age > 18 years
- written informed consent
Who cannot join
- ongoing need for opiates
- >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 Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed.
In some patients when food by mouth restarts they have pain and as a consequence they have a longer stay in hospital. It is thought that patients who have little pain and are within 24 hours of admission to hospital do well if they control their own food intake. This is in contrast to the usual treatment where the treating team advise when eating should restart.
- Conditions
- Acute Pancreatitis
- Being tested
- Patient-controlled oral refeeding
- Keywords
- Acute pancreatitis, nutrition
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-controlled oral refeedingOther
| Study group | Role | What they receive |
|---|---|---|
| Patient-controlled oral refeeding | Experimental | Patients will be allowed to drink and eat hospital food freely as tolerated. Receives: Other: Patient-controlled oral refeeding |
| Conventional management | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral food intolerance
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes (11)
Time from admission until tolerance of oral food
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Total length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Need for opiates
Need for opiates is defined when one (or more) of the following has been administered:
- Codeine phosphate
- Fentanyl
- Morphine, Sevredol, Meslon
- Oxynorm, Oxycodone
- Tramadol
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Change in pain intensity
Measured: Baseline and 24, 48, 72h after randomisation
Progression of acute pancreatitis severity
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Hospital readmission
Measured: 2 weeks after hospital discharge
Local and systemic complications
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Number and type of interventions during hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Time from admission until first flatus
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Change in blood glucose
Measured: Baseline and 24, 48, 72h after randomisation
Change in plasma C-reactive protein
Measured: Baseline and 24, 48, 72h after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study start1 Dec 2013
- Primary completion1 Jun 2018
- Study completion1 Jun 2019
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
- Enrolment
- 56 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728896
- Sponsor's protocol ID
- NTX/12/06/051
- Acronym
- PICTOR
- Status last verified
- Sep 2019
- First submitted
- 5 Nov 2012
- 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 Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01728896
- Acronym / sponsor ID
- PICTOR / NTX/12/06/051
- Conditions
- Acute Pancreatitis
- Keywords
- Acute pancreatitis, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 20 Nov 2012 (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.
The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed.
In some patients when food by mouth restarts they have pain and as a consequence they have a longer stay in hospital. It is thought that patients who have little pain and are within 24 hours of admission to hospital do well if they control their own food intake. This is in contrast to the usual treatment where the treating team advise when eating should restart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-controlled oral refeeding | Experimental | Other: Patient-controlled oral refeedingPatients will be allowed to drink and eat hospital food freely as tolerated. |
| Conventional management | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of acute pancreatitis
- age > 18 years
- written informed consent
Key exclusion criteria (8 listed)
- ongoing need for opiates
- >96 hours after onset of symptoms
- chronic pancreatitis
- post-ERCP pancreatitis
- intraoperative diagnosis
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 |
|---|---|---|
| Patient-controlled oral refeeding | Other | Patient-controlled oral refeeding |
Primary outcome
Oral food intolerance
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
11 secondary outcomes
Time from admission until tolerance of oral food
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Total length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Need for opiates
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Change in pain intensity
Time frame: Baseline and 24, 48, 72h after randomisation
Progression of acute pancreatitis severity
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Hospital readmission
Time frame: 2 weeks after hospital discharge
Local and systemic complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Number and type of interventions during hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Time from admission until first flatus
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Change in blood glucose
Time frame: Baseline and 24, 48, 72h after randomisation
Change in plasma C-reactive protein
Time frame: Baseline and 24, 48, 72h after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 3 inclusion and 8 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oral food intolerance (time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days). 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.