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

ABSTRACT: 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.

SUBMITTER: Bellin MD

PROVIDER: S-EPMC5879010 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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

Bellin Melena D MD Abu-El-Haija Maisam M Morgan Katherine K Adams David D Beilman Gregory J GJ Chinnakotla Srinath S Conwell Darwin L DL Dunn Ty B TB Freeman Martin L ML Gardner Timothy T Kirchner Varvara A VA Lara Luis F LF Long-Simpson Leslie L Nathan Jaimie D JD Naziruddin Bashoo B Nyman John A JA Pruett Timothy L TL Schwarzenberg Sarah J SJ Singh Vikesh K VK Smith Kerrington K Steel Jennifer L JL Wijkstrom Martin M Witkowski Piotr P Hodges James S JS

Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] 20180206 3

<h4>Background/objectives</h4>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.<h4>Methods</h4>Multiple centers across the United States (9 to date) performing TPIAT are ...[more]

PMID: 29456124

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Project description:ImportancePain management of patients with chronic pancreatitis (CP) can be challenging. Laparoscopy has been associated with markedly reduced postoperative pain but has not been widely applied to total pancreatectomy with islet autotransplantation (TPIAT).ObjectiveTo examine the feasibility of using laparoscopic TPIAT (L-TPIAT) in the treatment of CP.Design, setting, and participantsThirty-two patients with CP presented for TPIAT at a tertiary hospital from January 1, 2013, through December 31, 2015. Of the 22 patients who underwent L-TPIAT, 2 patients converted to an open procedure because of difficult anatomy and prior surgery. Pain and glycemic outcomes were recorded at follow-up visits every 3 to 6 months postoperatively.Main outcomes and measuresOperative outcomes included operative time, islet isolation time, warm ischemia time, islet equivalent (IE) counts, estimated blood loss, fluid resuscitation, and blood transfusions. Postoperative outcomes included length of stay, all-cause 30-day readmission rate, postoperative complications, mortality rate, subjective pain measurements, opioid use, random C-peptide levels, insulin requirements, and glycated hemoglobin level.ResultsOf the 32 patients who presented for TPIAT, 20 underwent L-TPIAT (8 men and 12 women; mean [SD] age, 39 [13] years; age range, 21-58 years). Indication for surgery was CP attributable to genetic mutation (n = 9), idiopathic pancreatitis (n = 6), idiopathic pancreatitis with pancreas divisum (n = 3), and alcohol abuse (n = 2). Mean (SD) operative time was 493 (78) minutes, islet isolation time was 185 (37) minutes, and warm ischemia time was 51 (62) minutes. The mean (SD) IE count was 1325 (1093) IE/kg. The mean (SD) length of stay was 11 (5) days, and the all-cause 30-day readmission rate was 35% (7 of 20 patients). None of the patients experienced postoperative surgical site infection, hernia, or small-bowel obstruction, and none died. Eighteen patients (90%) had a decrease or complete resolution of pain, and 12 patients (60%) no longer required opioid therapy at a median follow-up period of 6 months. Postoperative random insulin C-peptide levels were detectable in 19 patients (95%) at a median follow-up of 10.4 months. At a median follow-up of 12.5 months, 5 patients (25%) were insulin independent, whereas 9 patients (45%) required 1 to 10 U/d, 5 patients (25%) required 11 to 20 U/d, and 1 patient (5%) required greater than 20 U/d of basal insulin. The mean (SD) glycated hemoglobin level was 7.4% (0.5%).Conclusions and relevanceThis study represents the first series of L-TPIAT, demonstrating its safety and feasibility. Our approach enables patients to experience shorter operative times and the benefits of laparoscopy, including reduced length of stay and quicker opioid independence.

Project description:Total pancreatectomy with islet cell autotransplantation (TPIAT) is a surgical treatment modality used for the management of painful chronic pancreatitis when medical and endoscopic therapies fail. Total pancreatectomy (TP) results in a number of clinical implications. However, the glucose-responsive insulin secretion can be preserved by combining TP with islet cell autotransplant (IAT). Despite the known clinical implications of TPIAT, the systemic molecular effects of TPIAT remains poorly investigated. Therefore, we performed the first hypothesis-generating study of the urinary proteome before and after TPIAT. The RAW- and processed data from the analysis can be found in this repository. Twenty-two chronic pancreatitis patients eligible for TPIAT were prospectively enrolled in the study at the University of Minnesota Medical Center between September 2011 and February 2014. Urine was collected within the week pre-TPIAT and 12-18 months post-TPIAT, resulting in 44 paired samples. The paired experimental design allowed us to subtract interpersonal differences. The unique set of urine samples were prepared for bottom-up label-free quantitative proteomics using the in-house developed ‘MStern’ protocol for the 96-well plate compatible processing of the urine samples. The samples were analyzed by LC-MS/MS and 2477 proteins were identified (FDR<0.01%). Five samples were found to have less than 30% of the cumulated list of proteins (<743 proteins) and so these samples and their respective matching sample were thus removed from the analysis. This resulted in a complete dataset with 17 matched pre- and post-TPIAT sample pairs. The final list of recommended included pairs for future analysis are indicated in the PX_TPIAT_Metadata.csv file. Note that extended clinical information only was available for the included samples. Furthermore, the information is only listed for the pre-TPIAT sample but applies to both the pre- and post-TPIAT participant sample. The data allows for studying the systemic molecular impact of the TPIAT procedure.

Dataset Information

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

Publications

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

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