Background/objectives: Total pancreatectomy with islet autotransplantation (TPIAT) is considered for managing chronic pancreatitis in selected patients when medical and endoscopic interventions have not provided adequate relief from debilitating pain. Although more centers are performing TPIAT, we lack large, multi-center studies to guide decisions about selecting candidates for and timing of TPIAT. Methods: Multiple centers across the United States (9 to date) performing TPIAT are prospectively enrolling patients undergoing TPIAT for chronic pancreatitis into the Prospective Observational Study of TPIAT (POST), a NIDDK funded study with a goal of accruing 450 TPIAT recipients. Baseline data include participant phenotype, pancreatitis history, and medical/psychological comorbidities from medical records, participant interview, and participant self-report (Medical Outcomes Survey Short Form-12, EQ-5D, andPROMIS inventories for pain interference, depression, and anxiety). Outcome measures are collected to at least 1 year after TPIAT, including the same participant questionnaires, visual analog pain scale, pain interference scores, opioid requirements, insulin requirements, islet graft function, and hemoglobin A1c. Health resource utilization data are collected for a cost-effectiveness analysis. Biorepository specimens including urine, serum/plasma, genetic material (saliva and blood), and pancreas tissue are collected for future study. Conclusions: This ongoing multicenter research study will enroll and follow TPIAT recipients, aiming to evaluate patient selection and timing for TPIAT to optimize pain relief, quality of life, and diabetes outcomes, and to measure the procedure's cost-effectiveness. A biorepository is also established for future ancillary studies.
Bibliographical noteFunding Information:
The study is funded by the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK, R01- DK109124 , PI M. Bellin). Research reported in this publication was additionally supported by the National Cancer Institute and NIDDK under award number U01DK108327 (DC). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors have no conflicts of interest to disclose relevant to this manuscript. The authors would like to acknowledge the efforts of the supporting team members Helen Voelker (University of Minnesota, DCC database management), Yi Yang (University of Minnesota, Biostatistics), Joshua J. Wilhelm (University of Minnesota, islet lab), Dr, Kenneth Washburn (The Ohio State University, Surgery), and Dr, Amer Rajab (The Ohio State University, Surgery and Islet Isolation), and the following study coordinators: Peggy Ptacek (University of Minnesota), Jayne Pederson (University of Minnesota), Anne Elizabeth Farrow (Baylor), Jovana Valdez (Baylor), Misty Troutt (Cincinnati Children's Hospital), Amanda Schreibeis (Cincinnati Children's Hospital), Jessica Chevalier (Dartmouth Hitchcock), Jessica Hiscoe (Dartmouth Hitchcock), Mahya Faghih (John Hopkins), Sheila Fedorek (University of Pittsburgh), Lindsay Basto (University of Chicago), Mortadha Abd (Medical University of South Carolina), Caitlin Schaffner (Medical University of South Carolina), Casey McClurkin (The Ohio State University), Brianna Conley (The Ohio State University), Alejandra Cervantes (The Ohio State University), Jill Buss (The Ohio State University), Emily Bowns (The Ohio State University).
- Total pancreatectomy