Patient-Initiated and ConTrolled Oral Refeeding (PICTOR) (PICTOR)

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.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Other: Patient-controlled oral refeeding

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • University of Auckland; Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Auckland, New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Acute pancreatitis, nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: NTX/12/06/051