Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)
PICTOR
A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
1 other identifier
interventional
56
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedSeptember 26, 2019
September 1, 2019
4.5 years
November 5, 2012
September 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oral food intolerance
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
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Total length of hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Need for opiates
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Change in pain intensity
Baseline and 24, 48, 72h after randomisation
Progression of acute pancreatitis severity
Participants will be followed for the duration of hospital stay, an expected average of 7 days
- +6 more secondary outcomes
Study Arms (2)
Patient-controlled oral refeeding
EXPERIMENTALPatients will be allowed to drink and eat hospital food freely as tolerated.
Conventional management
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- diagnosis of acute pancreatitis
- age \> 18 years
- written informed consent
You may not qualify if:
- ongoing need for opiates
- \>96 hours after onset of symptoms
- chronic pancreatitis
- post-ERCP pancreatitis
- intraoperative diagnosis
- pregnancy
- malignancy
- received nutrition before randomisation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Auckland; Auckland City Hospital
Auckland, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicpal Investigator Dr. Max Petrov
Study Record Dates
First Submitted
November 5, 2012
First Posted
November 20, 2012
Study Start
December 1, 2013
Primary Completion
June 1, 2018
Study Completion
June 1, 2019
Last Updated
September 26, 2019
Record last verified: 2019-09