<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/NCT03260387</url>
  </required_header>
  <id_info>
    <org_study_id>PEDS-2019-26517</org_study_id>
    <secondary_id>R01DK109124</secondary_id>
    <nct_id>NCT03260387</nct_id>
  </id_info>
  <brief_title>A Prospective Observational Study of TPIAT</brief_title>
  <acronym>POST</acronym>
  <official_title>Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baylor Health Care System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multi-center, prospective, observational cohort study of patients undergoing total&#xD;
      pancreatectomy with islet autotransplantation (TPIAT)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who are undergoing TPIAT at one of the participating center are invited to&#xD;
      participate in this observational study, with 450 participants anticipated. The aims of the&#xD;
      study are:&#xD;
&#xD;
      Aim 1: To determine (1a) whether patient and disease characteristics are associated with&#xD;
      favorable pain and health-related quality-of-life outcomes (HRQOL) after TPIAT; (1b) the&#xD;
      optimal timing of the TPIAT intervention to resolve pain and improve HRQOL; and (1c) in a&#xD;
      subset of patients, the impact of central sensitization on pain resolution.&#xD;
&#xD;
      Aim 2: To determine (2a) whether patient and disease characteristics are associated with&#xD;
      favorable glycemic outcomes from the IAT procedure; and (2b) the optimal timing of TPIAT to&#xD;
      obtain post-surgical insulin independence.&#xD;
&#xD;
      Aim 3: To determine the cost-effectiveness of TPIAT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Reduction</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Visual Analog Pain Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Physical Component Summary Score from SF-12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Mental Component Summary Score from SF-12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Proportion of patients insulin independent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Use</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>proportion off opioid analgesics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Use</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Morphine Equivalents (avg daily ME)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Control</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>HbA1c level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin Dose</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Insulin Dose (U/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Islet Graft Function</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Proportion with Islet Graft Function (C-peptide + or Off Insulin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Hypoglycemia Episodes</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Proportion of patients with Severe Hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Interference</measure>
    <time_frame>Mos 6, Years 1, 2, 3, 4 after surgery</time_frame>
    <description>Pain interference Score (PROMIS scale)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">433</enrollment>
  <condition>Pancreatitis, Chronic</condition>
  <condition>Pancreatectomy; Hyperglycemia</condition>
  <condition>Pancreatitis</condition>
  <arm_group>
    <arm_group_label>TPIAT</arm_group_label>
    <description>patients undergoing total pancreatectomy with islet autotransplant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TPIAT</intervention_name>
    <description>The entire pancreas is removed to treat the pain of chronic pancreatitis, and the islets are infused back into the patient to reduce diabetes risk after surgery.</description>
    <arm_group_label>TPIAT</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Optional (opt in) biorepository samples:&#xD;
&#xD;
        1. Blood (plasma, serum, buffy coat)&#xD;
&#xD;
        2. Urine&#xD;
&#xD;
        3. Saliva&#xD;
&#xD;
        4. Pancreas biopsy at time of surgery&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children and Adults undergoing TPIAT for severe pancreatitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion&#xD;
        pancreatectomy with islet autotransplantation at a participating center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Partial pancreatectomy&#xD;
&#xD;
          2. TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis&#xD;
             (for example benign or malignant pancreatic tumor)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40292</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>total pancreatectomy</keyword>
  <keyword>acute pancreatitis</keyword>
  <keyword>chronic pancreatitis</keyword>
  <keyword>islet transplant</keyword>
  <keyword>islet autotransplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03260387
org study id: PEDS-2019-26517
secondary id: R01DK109124
nct id: NCT03260387
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multi-center, prospective, observational cohort study of patients undergoing total
      pancreatectomy with islet autotransplantation (TPIAT)
Patients who are undergoing TPIAT at one of the participating center are invited to
      participate in this observational study, with 450 participants anticipated. The aims of the
      study are:

      Aim 1: To determine (1a) whether patient and disease characteristics are associated with
      favorable pain and health-related quality-of-life outcomes (HRQOL) after TPIAT; (1b) the
      optimal timing of the TPIAT intervention to resolve pain and improve HRQOL; and (1c) in a
      subset of patients, the impact of central sensitization on pain resolution.

      Aim 2: To determine (2a) whether patient and disease characteristics are associated with
      favorable glycemic outcomes from the IAT procedure; and (2b) the optimal timing of TPIAT to
      obtain post-surgical insulin independence.

      Aim 3: To determine the cost-effectiveness of TPIAT.
observational model: Cohort
time perspective: Prospective
measure: Pain Reduction
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Visual Analog Pain Scale
measure: Quality of Life
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Physical Component Summary Score from SF-12
measure: Quality of Life
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Mental Component Summary Score from SF-12
measure: Diabetes
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Proportion of patients insulin independent
measure: Opioid Use
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: proportion off opioid analgesics
measure: Opioid Use
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Morphine Equivalents (avg daily ME)
measure: Glycemic Control
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: HbA1c level
measure: Insulin Dose
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Insulin Dose (U/day)
measure: Islet Graft Function
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Proportion with Islet Graft Function (C-peptide + or Off Insulin)
measure: Severe Hypoglycemia Episodes
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Proportion of patients with Severe Hypoglycemia
measure: Pain Interference
time frame: Mos 6, Years 1, 2, 3, 4 after surgery
description: Pain interference Score (PROMIS scale)
arm group label: TPIAT
description: patients undergoing total pancreatectomy with islet autotransplant.
intervention type: Procedure
intervention name: TPIAT
description: The entire pancreas is removed to treat the pain of chronic pancreatitis, and the islets are infused back into the patient to reduce diabetes risk after surgery.
arm group label: TPIAT
Optional (opt in) biorepository samples:

        1. Blood (plasma, serum, buffy coat)

        2. Urine

        3. Saliva

        4. Pancreas biopsy at time of surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic
mesh term: Hyperglycemia
sharing ipd: No