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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 : October 27, 2020
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

Tracking Information
First Submitted Date August 21, 2017
First Posted Date August 24, 2017
Last Update Posted Date October 27, 2020
Actual Study Start Date January 1, 2017
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2017)
  • Pain Reduction [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Visual Analog Pain Scale
  • Quality of Life [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Physical Component Summary Score from SF-12
  • Quality of Life [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Mental Component Summary Score from SF-12
  • Diabetes [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Proportion of patients insulin independent
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 21, 2017)
  • Opioid Use [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    proportion off opioid analgesics
  • Opioid Use [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Morphine Equivalents (avg daily ME)
  • Glycemic Control [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    HbA1c level
  • Insulin Dose [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Insulin Dose (U/day)
  • Islet Graft Function [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Proportion with Islet Graft Function (C-peptide + or Off Insulin)
  • Severe Hypoglycemia Episodes [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Proportion of patients with Severe Hypoglycemia
  • Pain Interference [ Time Frame: Mos 6, Years 1, 2, 3, 4 after surgery ]
    Pain interference Score (PROMIS scale)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Observational Study of TPIAT
Official Title Advancing Treatment for Pancreatitis: A Prospective Observational Study of TPIAT (POST)
Brief Summary Multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Optional (opt in) biorepository samples:

  1. Blood (plasma, serum, buffy coat)
  2. Urine
  3. Saliva
  4. Pancreas biopsy at time of surgery
Sampling Method Non-Probability Sample
Study Population Children and Adults undergoing TPIAT for severe pancreatitis.
Condition
  • Pancreatitis, Chronic
  • Pancreatectomy; Hyperglycemia
  • Pancreatitis
Intervention 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.
Study Groups/Cohorts TPIAT
patients undergoing total pancreatectomy with islet autotransplant.
Intervention: Procedure: TPIAT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 21, 2017)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Melena Bellin, MD 612-625-4686 bell0130@umn.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03260387
Other Study ID Numbers PEDS-2019-26517
R01DK109124 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor University of Minnesota
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)
Investigators Not Provided
PRS Account University of Minnesota
Verification Date October 2020