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.
Study Type
OBSERVATIONAL
Enrollment
433
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.
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
Pain Reduction
Visual Analog Pain Scale
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Quality of Life
Physical Component Summary Score from SF-12
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Quality of Life
Mental Component Summary Score from SF-12
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Diabetes
Proportion of patients insulin independent
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Opioid Use
proportion off opioid analgesics
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Opioid Use
Morphine Equivalents (avg daily ME)
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Glycemic Control
HbA1c level
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Insulin Dose
Insulin Dose (U/day)
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Islet Graft Function
Proportion with Islet Graft Function (C-peptide + or Off Insulin)
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
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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
...and 2 more locations
Severe Hypoglycemia Episodes
Proportion of patients with Severe Hypoglycemia
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery
Pain Interference
Pain interference Score (PROMIS scale)
Time frame: Mos 6, Years 1, 2, 3, 4 after surgery