Pancreatectomy; Hyperglycemia, Pancreatitis, Pancreatitis, Chronic
Conditions
Keywords
pediatric, total pancreatectomy, acute pancreatitis, chronic pancreatitis, islet transplant, islet autotransplant
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.
Interventions
PROCEDURETPIAT
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.
Sponsors
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)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | Mos 6, Years 1, 2, 3, 4 after surgery | Visual Analog Pain Scale |
| Quality of Life | Mos 6, Years 1, 2, 3, 4 after surgery | Physical Component Summary Score from SF-12 |
| Diabetes | Mos 6, Years 1, 2, 3, 4 after surgery | Proportion of patients insulin independent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | Mos 6, Years 1, 2, 3, 4 after surgery | proportion off opioid analgesics |
| Glycemic Control | Mos 6, Years 1, 2, 3, 4 after surgery | HbA1c level |
| Insulin Dose | Mos 6, Years 1, 2, 3, 4 after surgery | Insulin Dose (U/day) |
| Islet Graft Function | Mos 6, Years 1, 2, 3, 4 after surgery | Proportion with Islet Graft Function (C-peptide + or Off Insulin) |
| Severe Hypoglycemia Episodes | Mos 6, Years 1, 2, 3, 4 after surgery | Proportion of patients with Severe Hypoglycemia |
| Pain Interference | Mos 6, Years 1, 2, 3, 4 after surgery | Pain interference Score (PROMIS scale) |
Countries
United States
Outcome results
None listed