Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)

Acute Pancreatitis Clinical Trial

— PICTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728896
• Other study ID #: NTX/12/06/051
• Status: Completed
• Phase: N/A
• Start date: December 1, 2013
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2019
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Other:
• Patient-controlled oral refeeding

Locations

Country	Name	City	State
New Zealand	University of Auckland; Auckland City Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral food intolerance		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Time from admission until tolerance of oral food		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Total length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	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
Secondary	Change in pain intensity		Baseline and 24, 48, 72h after randomisation
Secondary	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
Secondary	Hospital readmission		2 weeks after hospital discharge
Secondary	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
Secondary	Number and type of interventions during hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Time from admission until first flatus		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Change in blood glucose		Baseline and 24, 48, 72h after randomisation
Secondary	Change in plasma C-reactive protein		Baseline and 24, 48, 72h after randomisation