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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01728896




Registration number
NCT01728896
Ethics application status
Date submitted
5/11/2012
Date registered
20/11/2012
Date last updated
26/09/2019

Titles & IDs
Public title
Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)
Scientific title
A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
Secondary ID [1] 0 0
NTX/12/06/051
Universal Trial Number (UTN)
Trial acronym
PICTOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pancreatitis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Patient-controlled oral refeeding

Experimental: Patient-controlled oral refeeding - Patients will be allowed to drink and eat hospital food freely as tolerated.

No Intervention: Conventional management -


Other interventions: Patient-controlled oral refeeding
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Oral food intolerance
Timepoint [1] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [1] 0 0
Time from admission until tolerance of oral food
Timepoint [1] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [2] 0 0
Total length of hospital stay
Timepoint [2] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [3] 0 0
Need for opiates
Timepoint [3] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [4] 0 0
Change in pain intensity
Timepoint [4] 0 0
Baseline and 24, 48, 72h after randomisation
Secondary outcome [5] 0 0
Progression of acute pancreatitis severity
Timepoint [5] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [6] 0 0
Hospital readmission
Timepoint [6] 0 0
2 weeks after hospital discharge
Secondary outcome [7] 0 0
Local and systemic complications
Timepoint [7] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [8] 0 0
Number and type of interventions during hospital stay
Timepoint [8] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [9] 0 0
Time from admission until first flatus
Timepoint [9] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [10] 0 0
Change in blood glucose
Timepoint [10] 0 0
Baseline and 24, 48, 72h after randomisation
Secondary outcome [11] 0 0
Change in plasma C-reactive protein
Timepoint [11] 0 0
Baseline and 24, 48, 72h after randomisation

Eligibility
Key inclusion criteria
- diagnosis of acute pancreatitis

- age > 18 years

- written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- ongoing need for opiates

- >96 hours after onset of symptoms

- chronic pancreatitis

- post-ERCP pancreatitis

- intraoperative diagnosis

- pregnancy

- malignancy

- received nutrition before randomisation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2019
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01728896
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01728896