A multicenter study of total pancreatectomy with islet autotransplantation (TPIAT): POST (Prospective Observational Study of TPIAT)

作者:Bellin Melena D*; Abu El Haija Maisam; Morgan Katherine; Adams David; Beilman Gregory J; Chinnakotla Srinath; Conwell Darwin L; Dunn Ty B; Freeman Martin L; Gardner Timothy; Kirchner Varvara A; Lara Luis F; Long Simpson Leslie; Nathan Jaimie D; Naziruddin Bashoo; Nyman John A; Pruett Timothy L; Schwarzenberg Sarah J; Singh Vikesh K; Smith Kerrington; Steel Jennifer L; Wijkstrom Martin; Witkowski Piotr; Hodges James S
来源:Pancreatology, 2018, 18(3): 286-290.
DOI:10.1016/j.pan.2018.02.001

摘要

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. Bio-repository 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.

  • 出版日期2018-4