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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK109124 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Baylor Health Care System | OTHER |
| Medical University of South Carolina | OTHER |
| University of Chicago | OTHER |
| University of Pittsburgh Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPIAT | patients undergoing total pancreatectomy with islet autotransplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPIAT | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Reduction | Visual Analog Pain Scale | Mos 6, Years 1, 2, 3, 4 after surgery |
| Quality of Life | Physical Component Summary Score from SF-12 | Mos 6, Years 1, 2, 3, 4 after surgery |
| Quality of Life | Mental Component Summary Score from SF-12 | Mos 6, Years 1, 2, 3, 4 after surgery |
| Diabetes | Proportion of patients insulin independent | Mos 6, Years 1, 2, 3, 4 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | proportion off opioid analgesics | Mos 6, Years 1, 2, 3, 4 after surgery |
| Opioid Use | Morphine Equivalents (avg daily ME) |
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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:
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Children and Adults undergoing TPIAT for severe pancreatitis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| The University of Chicago Medical Center |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D006943 | Hyperglycemia |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| 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 |
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Optional (opt in) biorepository samples:
| Mos 6, Years 1, 2, 3, 4 after surgery |
| Glycemic Control | HbA1c level | Mos 6, Years 1, 2, 3, 4 after surgery |
| Insulin Dose | Insulin Dose (U/day) | Mos 6, Years 1, 2, 3, 4 after surgery |
| Islet Graft Function | Proportion with Islet Graft Function (C-peptide + or Off Insulin) | Mos 6, Years 1, 2, 3, 4 after surgery |
| Severe Hypoglycemia Episodes | Proportion of patients with Severe Hypoglycemia | Mos 6, Years 1, 2, 3, 4 after surgery |
| Pain Interference | Pain interference Score (PROMIS scale) | Mos 6, Years 1, 2, 3, 4 after surgery |
| Chicago |
| Illinois |
| 60637 |
| United States |
| University of Louisville | Louisville | Kentucky | 40292 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pittsburgh Medical Center, Thomas E. Starzl Transplantation Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |