Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Other: Patient-controlled oral refeeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of acute pancreatitis age > 18 years written informed consent 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-controlled oral refeeding<br>Patients will be allowed to drink and eat hospital food freely as tolerated. | Other: Patient-controlled oral refeeding<br> <br> |
| No Intervention: Conventional management<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral food intolerance |  | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Need for opiates is defined when one (or more) of the following has been administered: Codeine phosphate Fentanyl Morphine, Sevredol, Meslon Oxynorm, Oxycodone Tramadol | 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 | To be defined according to the 2012 determinant-based classification of acute pancreatitis severity | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Hospital readmission |  | 2 weeks after hospital discharge | 
| Local and systemic complications | To be defined according to the 2012 determinant-based classification of acute pancreatitis severity | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Number and type of interventions during hospital stay |  | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Time from admission until first flatus |  | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Change in blood glucose |  | Baseline and 24, 48, 72h after randomisation | 
| Change in plasma C-reactive protein |  | Baseline and 24, 48, 72h after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pancreatitis, nutrition