The Liver Transplant Program at the University of North Carolina at Chapel Hill (UNC-CH) is a well-established and vitally important regional resource. This application proposes a multi-center cooperative core study in which a well-defined cohort from UNC-CH and other Transplant Centers (TC) will be followed prospectively to provide reliable, complete, and generalizable information on adult donor and recipient outcomes for both living donor and cadaveric liver transplants. A database structure and information core is proposed, and this application discusses the relevance of each proposed data element. This core study will be augmented by analysis of our historical cohort for which existing outcome data can be pooled across all the Transplant Centers (TC) participating in the Clinical Research Consortium. In addition to these studies, this application proposes two common protocols. The first will examine in-depth the short and long-term morbidity and quality of life of living donors. The second will examine differences in drug metabolism and immunosuppressive regimen between recipients of living donor and cadaveric liver transplants. UNC-CH is well qualified to be a Transplant Center (TC) within the Clinical Research Consortium having performed 13 LDLT in the last 18 months and 21 LDLT total. Projections for UNC-CH are 50-60 CADLT and 15-20 LDLT per year, thereby allowing accrual and followup of more than sufficient numbers of patients to contribute to the Consortium studies. Overall one-year patient and graft survival for both CADLT and LDLT are 90-95% and 77-85% respectively. The UNC-CH infrastructure includes 4 transplant surgeons, 5 hepatologists, and other relevant professionals in vascular surgery, anesthesiology, radiology and vascular/interventional radiology, immunology, infectious disease, pulmonary disease, pathology, pharmacy, nursing, blood bank, psychiatry or psychology and social services. All studies benefit from use of the Verne Caviness General Clinical Research Center (GCRC) as a primary site and collaboration with the Center for Gastrointestinal Biology and Disease (CGIBD). Particularly relevant to this application are the GCRC's Informatics Services and the epidemiologic services of the CGIBD.As a Transplant Center, UNC-CH is committed to close collaborations including membership on the Steering Committee. UNC-CH has participated in multiple multi-center trials and has a rich experiential base in working with data coordinating centers. Our application's strong institutional support for participation as a TC includes acceptance of per patient funding mechanisms for the common protocols.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZDK1-GRB-D (M1))
Program Officer
Everhart, James
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Project End
Budget Start
Budget End
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Fiscal Year
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University of North Carolina Chapel Hill
Internal Medicine/Medicine
Schools of Medicine
Chapel Hill
United States
Zip Code
Butt, Zeeshan; DiMartini, Andrea F; Liu, Qian et al. (2018) Fatigue, Pain, and Other Physical Symptoms of Living Liver Donors in the Adult-to-Adult Living Donor Liver Transplantation Cohort Study. Liver Transpl 24:1221-1232
Butt, Z; Dew, M A; Liu, Q et al. (2017) Psychological Outcomes of Living Liver Donors From a Multicenter Prospective Study: Results From the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2). Am J Transplant 17:1267-1277
Levitsky, Josh; Goldberg, David; Smith, Abigail R et al. (2017) Acute Rejection Increases Risk of Graft Failure and Death in Recent Liver Transplant Recipients. Clin Gastroenterol Hepatol 15:584-593.e2
Samstein, B; Smith, A R; Freise, C E et al. (2016) Complications and Their Resolution in Recipients of Deceased and Living Donor Liver Transplants: Findings From the A2ALL Cohort Study. Am J Transplant 16:594-602
Levitsky, J; Kaneku, H; Jie, C et al. (2016) Donor-Specific HLA Antibodies in Living Versus Deceased Donor Liver Transplant Recipients. Am J Transplant 16:2437-44
Gordon, Fredric D; Goldberg, David S; Goodrich, Nathan P et al. (2016) Recurrent primary sclerosing cholangitis in the Adult-to-Adult Living Donor Liver Transplantation Cohort Study: Comparison of risk factors between living and deceased donor recipients. Liver Transpl 22:1214-22
Pomposelli, James J; Goodrich, Nathan P; Emond, Jean C et al. (2016) Patterns of Early Allograft Dysfunction in Adult Live Donor Liver Transplantation: The A2ALL Experience. Transplantation 100:1490-9
Emond, Jean C; Fisher, Robert A; Everson, Gregory et al. (2015) Changes in liver and spleen volumes after living liver donation: a report from the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL). Liver Transpl 21:151-61
Ladner, Daniela P; Dew, Mary Amanda; Forney, Sarah et al. (2015) Long-term quality of life after liver donation in the adult to adult living donor liver transplantation cohort study (A2ALL). J Hepatol 62:346-53
Olthoff, Kim M; Emond, Jean C; Shearon, Tempie H et al. (2015) Liver regeneration after living donor transplantation: adult-to-adult living donor liver transplantation cohort study. Liver Transpl 21:79-88

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