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Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL)
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Hepatology, October 2003, Volume 38, Number 4
Liver transplantation is now the standard of care for patients with end-stage liver disease. In 2002, more than 4,500 liver transplantations were performed in the United States. At the same time, more than 18,000 patients were awaiting liver transplantation, and in recent years, the waiting list has continued to grow. As a consequence, the numbers of patients dying on the transplant waiting list has grown. The introduction of the MELD system was designed to assign livers to patients in greatest need and thus decrease waiting list mortality. This approach may be partially successful, but the continued shortage of cadaveric livers will mean that the mortality rate on the waiting list will remain high.
Among remedies to the shortage of livers for transplantation, living donor liver transplantation (LDLT) is perhaps the most immediately practicable, but is also quite controversial. LDLT has become widely accepted for pediatric patients. For children, the left lobe of an adult liver is adequate for transplantation, and this procedure (particularly from parent to child) has been done successfully for more than a decade. For adults, transplantation of a left lobe of the liver (~20% to 30% of the liver mass) is usually inadequate to support life, particularly in patients with end-stage liver disease. Transplantation of the right lobe (~50% to 60% of the liver mass) can be successful in adults, but the donor operation is more extensive and accordingly more life threatening. Adult-to-adult, right-lobe LDLT was introduced in the United States in 1997 and now accounts for almost 5% of adult liver transplantations. Nevertheless, the donor operation is challenging and potentially dangerous. Indeed, between 1998 to 2003, at least 2 healthy, adult donors died shortly after right-lobe liver donation.
To address these issues and set an agenda for future research, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the American Association for the Study of Liver Diseases cosponsored a 2-day workshop entitled “Living Donor Liver Transplantation” in December 2000, a summary of which has been published (Liver Transplantation 2002;8:174-88). A major conclusion from the meeting was the immediate and critical need for a prospective study of LDLT focusing on the relative risks and benefits of the use of living versus cadaveric livers and on the short- and long-term complications of the donor operation.
Accordingly, NIDDK has established a multicenter clinical study entitled the “Adult-to-Adult Living Donor Liver Transplantation Cohort Study” (A2ALL), which consists of 9 transplant centers experienced in performing LDLT and a data coordinating center responsible for directing and maintaining a clinical database. The primary goal of A2ALL will be to provide objective and reliable information on the outcomes of LDLT for both donors and recipients. Outcomes will be compared between recipients of living donation and potential living donor recipients who had a living donor evaluated but did not go through with the living donor transplantation, which is a common occurrence.
Both a prospective and a retrospective database of LDLTs will be established. Special areas of focus will include graft and patient survival, acute rejection, biliary complications, hepatitis C and its recurrence after transplantation, and quality of life. Major emphasis will also be placed on evaluation and follow-up of liver donors including careful analyses of the adequacy of informed consent, short- and long-term complications of the donor surgery, and long-term follow-up of donors assessing general health, quality of life, and personal and psychological effects of liver donation.
PRINCIPAL INVESTIGATORS and A2ALL LIVER TRANSPLANT CENTERS
--Michael Abecassis, M.D., Northwestern University, Chicago, IL;
--Carl Berg, M.D., University of Virginia, Charlottesville, VA;
--Mark Ghobrial, M.D., Ph.D., University of California, Los Angeles, CA;
--Jean Emond, M.D., Columbia University, New York , NY;
--Robert A. Fisher, M.D., Virginia Commonwealth University, Richmond, VA;
--Chris E. Freise, M.D., University of California, San Francisco, CA;
--Abraham Shaked, M.D., University of Pennsylvania, Philadelphia, PA;
--Roshan Shrestha, M.D., University of North Carolina, Chapel Hill, NC;
--James Trotter, M.D., University of Colorado Health Sciences Center, Denver, CO.
PRINCIPAL INVESTIGATOR
Robert Merion, M.D., University of Michigan, Ann Arbor, MI.
PROGRAM OFFICER FOR A2ALL STUDY
James Everhart, M.D., M.P.H., NIDDK, Bethesda, MD.
Additional support for A2ALL is provided by the American Society of Transplant Surgeons (ASTS) and the Health Resources Services Administration (HRSA) of the Department of Health and Human Services.
A2ALL was initiated in September 2002 and patient data accrual will begin in autumn of 2003. More information is available at http://www.nih-a2all.org/default.asp
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