Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
433 participants
OBSERVATIONAL
2017-01-01
2026-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TPIAT
patients undergoing total pancreatectomy with islet autotransplant.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. TPIAT performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)
ALL
No
Sponsors
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Baylor Health Care System
OTHER
Medical University of South Carolina
OTHER
University of Chicago
OTHER
University of Pittsburgh Medical Center
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Johns Hopkins University
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Ohio State University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Minnesota
OTHER
Responsible Party
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Locations
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University of California, San Francisco
San Francisco, California, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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PEDS-2019-26517
Identifier Type: -
Identifier Source: org_study_id
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