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A Prospective Observational Study of TPIAT (POST)

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ClinicalTrials.gov Identifier: NCT03260387
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : September 29, 2021
Sponsor:
Collaborators:
Baylor Health Care System
Medical University of South Carolina
University of Chicago
University of Pittsburgh Medical Center
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
Children's Hospital Medical Center, Cincinnati
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
Multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (TPIAT)

Condition or disease Intervention/treatment
Pancreatitis, Chronic Pancreatectomy; Hyperglycemia Pancreatitis Procedure: TPIAT

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Groups and Cohorts
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Group/Cohort Intervention/treatment
TPIAT
patients undergoing total pancreatectomy with islet autotransplant.
 Procedure: TPIAT
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.


Outcome Measures
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Primary Outcome Measures :
  1. Pain Reduction [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Visual Analog Pain Scale

  2. Quality of Life [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Physical Component Summary Score from SF-12

  3. Quality of Life [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Mental Component Summary Score from SF-12

  4. Diabetes [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Proportion of patients insulin independent


Secondary Outcome Measures :
  1. Opioid Use [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    proportion off opioid analgesics

  2. Opioid Use [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Morphine Equivalents (avg daily ME)

  3. Glycemic Control [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    HbA1c level

  4. Insulin Dose [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Insulin Dose (U/day)

  5. Islet Graft Function [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Proportion with Islet Graft Function (C-peptide + or Off Insulin)

  6. Severe Hypoglycemia Episodes [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Proportion of patients with Severe Hypoglycemia

  7. Pain Interference [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Pain interference Score (PROMIS scale)


Biospecimen Retention:   Samples With DNA

Optional (opt in) biorepository samples:

  1. Blood (plasma, serum, buffy coat)
  2. Urine
  3. Saliva
  4. Pancreas biopsy at time of surgery

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and Adults undergoing TPIAT for severe pancreatitis.
Criteria

Inclusion Criteria:

1. Any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center.

Exclusion Criteria:

  1. Partial pancreatectomy
  2. TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260387


Contacts
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Contact: Melena Bellin, MD 612-625-4686 bell0130@umn.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Joanne Kwan    415-476-2574    Joanne.Kwan@ucsf.edu   
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Lindsay Basto    773-702-2504    Lindsay.basto@uchospitals.edu   
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
Contact: Mechelle Kaufman    502-852-7507    mechelle.stoner@louisville.edu   
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Mahya Faghih    443-761-9157    mfaghih2@jhu.edu   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peggy Ptacek    612-626-5905    vorwa001@umn.edu   
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Penny Doughty    603-653-6048    Penny.J.Doughty@hitchcock.org   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jyoti Patel    513-636-0091    jyoti.patel@cchmc.org   
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Amy Orasko    216-444-3267    OraskoA@ccf.org   
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Jill Buss    614-292-9309    Jill.Buss@osumc.edu   
United States, Pennsylvania
University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Rita Johnson    412-383-8616    johnsonr1@upmc.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jason Hirsch    843-792-8824    hirschj@musc.edu   
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Rehma Shabbir    214-820-1768    rehma.shabbir@bswhealth.org   
Sponsors and Collaborators
University of Minnesota
Baylor Health Care System
Medical University of South Carolina
University of Chicago
University of Pittsburgh Medical Center
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
Children's Hospital Medical Center, Cincinnati
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03260387    
Other Study ID Numbers: PEDS-2019-26517
R01DK109124 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
pediatric
total pancreatectomy
acute pancreatitis
 chronic pancreatitis
islet transplant
islet autotransplant
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Hyperglycemia
Pancreatic Diseases
 Digestive System Diseases
Glucose Metabolism Disorders
Metabolic Diseases