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Completed

NCT Number: NCT01728896

Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Auckland; Auckland City Hospital

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-controlled oral refeeding

Other

Primary outcomes

  1. Oral food intolerance

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

Secondary outcomes

  1. Time from admission until tolerance of oral food

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

  2. Total length of hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

  3. Need for opiates

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    Need for opiates is defined when one (or more) of the following has been administered:

    • Codeine phosphate
    • Fentanyl
    • Morphine, Sevredol, Meslon
    • Oxynorm, Oxycodone
    • Tramadol

  4. Change in pain intensity

    Time frame: Baseline and 24, 48, 72h after randomisation

  5. Progression of acute pancreatitis severity

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    To be defined according to the 2012 determinant-based classification of acute pancreatitis severity

  6. Hospital readmission

    Time frame: 2 weeks after hospital discharge

  7. Local and systemic complications

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    To be defined according to the 2012 determinant-based classification of acute pancreatitis severity

  8. Number and type of interventions during hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

  9. Time from admission until first flatus

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

  10. Change in blood glucose

    Time frame: Baseline and 24, 48, 72h after randomisation

  11. Change in plasma C-reactive protein

    Time frame: Baseline and 24, 48, 72h after randomisation

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Registry information

Official study title

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

Acronym: PICTOR

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Nov 20, 2012
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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