<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01728896</url>
  </required_header>
  <id_info>
    <org_study_id>NTX/12/06/051</org_study_id>
    <nct_id>NCT01728896</nct_id>
  </id_info>
  <brief_title>Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)</brief_title>
  <acronym>PICTOR</acronym>
  <official_title>A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Auckland, New Zealand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Auckland, New Zealand</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The first step in treating patients with acute pancreatitis is to provide pain relief and&#xD;
      intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel&#xD;
      better food and fluids by mouth are restarted. This is done to rest the pancreas which is the&#xD;
      organ that has been inflamed.&#xD;
&#xD;
      In some patients when food by mouth restarts they have pain and as a consequence they have a&#xD;
      longer stay in hospital. It is thought that patients who have little pain and are within 24&#xD;
      hours of admission to hospital do well if they control their own food intake. This is in&#xD;
      contrast to the usual treatment where the treating team advise when eating should restart.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2013</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Oral food intolerance</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from admission until tolerance of oral food</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total length of hospital stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for opiates</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>Need for opiates is defined when one (or more) of the following has been administered:&#xD;
Codeine phosphate&#xD;
Fentanyl&#xD;
Morphine, Sevredol, Meslon&#xD;
Oxynorm, Oxycodone&#xD;
Tramadol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain intensity</measure>
    <time_frame>Baseline and 24, 48, 72h after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of acute pancreatitis severity</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>To be defined according to the 2012 determinant-based classification of acute pancreatitis severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmission</measure>
    <time_frame>2 weeks after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local and systemic complications</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>To be defined according to the 2012 determinant-based classification of acute pancreatitis severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and type of interventions during hospital stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from admission until first flatus</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood glucose</measure>
    <time_frame>Baseline and 24, 48, 72h after randomisation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma C-reactive protein</measure>
    <time_frame>Baseline and 24, 48, 72h after randomisation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Patient-controlled oral refeeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be allowed to drink and eat hospital food freely as tolerated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-controlled oral refeeding</intervention_name>
    <arm_group_label>Patient-controlled oral refeeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of acute pancreatitis&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ongoing need for opiates&#xD;
&#xD;
          -  &gt;96 hours after onset of symptoms&#xD;
&#xD;
          -  chronic pancreatitis&#xD;
&#xD;
          -  post-ERCP pancreatitis&#xD;
&#xD;
          -  intraoperative diagnosis&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  malignancy&#xD;
&#xD;
          -  received nutrition before randomisation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Auckland; Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Auckland, New Zealand</investigator_affiliation>
    <investigator_full_name>Max Petrov</investigator_full_name>
    <investigator_title>Prinicpal Investigator Dr. Max Petrov</investigator_title>
  </responsible_party>
  <keyword>Acute pancreatitis, nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01728896
org study id: NTX/12/06/051
nct id: NCT01728896
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
measure: Oral food intolerance
time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: 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
measure: Total length of hospital stay
time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Need for opiates
time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
description: Need for opiates is defined when one (or more) of the following has been administered:
Codeine phosphate
Fentanyl
Morphine, Sevredol, Meslon
Oxynorm, Oxycodone
Tramadol
measure: Change in pain intensity
time frame: Baseline and 24, 48, 72h after randomisation
measure: Progression of acute pancreatitis severity
time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
description: To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
measure: Hospital readmission
time frame: 2 weeks after hospital discharge
measure: Local and systemic complications
time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
description: To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
measure: 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
measure: Time from admission until first flatus
time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Change in blood glucose
time frame: Baseline and 24, 48, 72h after randomisation
measure: Change in plasma C-reactive protein
time frame: Baseline and 24, 48, 72h after randomisation
arm group label: Patient-controlled oral refeeding
arm group type: Experimental
description: Patients will be allowed to drink and eat hospital food freely as tolerated.
arm group label: Conventional management
arm group type: No Intervention
intervention type: Other
intervention name: Patient-controlled oral refeeding
arm group label: Patient-controlled oral refeeding
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: New Zealand
responsible party type: Principal Investigator
investigator affiliation: University of Auckland, New Zealand
investigator full name: Max Petrov
investigator title: Prinicpal Investigator Dr. Max Petrov
mesh term: Pancreatitis