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Living Donor Liver Transplantationhttp://www.clinicaltrials.gov/ct/show/NCT00096733?order=1
Home | Search | Browse | Resources | Help | What's New | About Adult-to-Adult Living Donor Liver Transplantation Study This study is currently recruiting patients. Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Society of Transplant Surgeons
HRSA/Maternal and Child Health Bureau
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Purpose There are two principal purposes of this study: 1) to determine whether it is more beneficial for a liver transplant recipient candidate to pursue a living donor liver transplant (LDLT) or wait for a deceased donor liver transplant (DDLT), and 2) to study the impact of liver donation on the donor's health and quality of life. Condition
Cirrhosis
Hepatitis C
Hepatocellular Carcinoma
MedlinePlus related topics: Hepatitis C; Liver Cancer
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title: Adult-to-Adult Living Donor Liver Transplantation Cohort Study Further Study Details: Expected Total Enrollment: 2470
Study start: October 2004; Expected completion: July 2009
Last follow-up: July 2008; Data entry closure: December 2008
Adult to adult living donor liver transplantation (LDLT) is a relatively new procedure increasingly used at major transplantation centers. Relatively small numbers of cases are performed at any one center and approaches to the patient and donor are too diverse across centers to provide reliable and generalizable information on donor and recipient outcomes from individual centers. Therefore, a network of nine leading liver transplantation centers and a data coordination center (DCC) has been organized to accrue and follow sufficient numbers of patients being considered for and undergoing LDLT to provide generalizable results from adequately powered studies. This network has established the Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) that will conduct both retrospective and prospective studies of LDLT.
The primary study objective is to analyze the effect of choosing to pursue living liver donation. The principal hypothesis is that pursuit of a living liver allograft leads to decreased pre-transplant morbidity and mortality and better long term outcomes for patients starting from the point at which listed patients have a potential donor evaluated (at least a history and physical examination). Emerging data suggest that LDLT provides an inferior graft because of reduced parenchymal mass and added technical complexity when compared to a whole liver used for DDLT. The magnitude of the disadvantage to the LDLT graft will be assessed by comparing results between LDLT and DDLT from the time of transplant. Finally, a careful and detailed series of studies of potential and actual living liver donors is included as a primary objective because of the tremendous importance of this issue to our understanding of the impact of the procedure. Secondary objectives will address selected biological and clinical issues in transplantation structured around the comparison between DDLT and LDLT.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria - Potential Recipients: Potential recipient listed for single organ (liver) transplantation
Patient is eligible for LDLT
Age ≥ 18 years old at the time of donor history and physical exam
Indication for transplant: non-fulminant liver disease
Potential donor scheduled for evaluation (history and physical examination) within four weeks
Location and Contact Information
Douglas R Armstrong, RN, BSN, MS 734-998-6586 darms@umich.edu
Peg Hill-Callahan, BS, LSW 734-998-6618 peghc@umich.edu
California
University of California Los Angeles, Los Angeles, California, 90095-7054, United States; Recruiting
Lucy Artinian, RN 310-825-5318 lartinia@mednet.ucla.edu
R. Mark Ghobrial, MD, Principal Investigator
Ronald W. Busuttil, MD, Sub-Investigator
University of California San Francisco, San Francisco, California, 94143-0538, United States; Recruiting
Dulce MacLeod, RN 415-476-3170 macleodd@surgery.ucsf.edu
Chris Freise, MD, Principal Investigator
Norah Terrault, MD, Sub-Investigator
Colorado
University of Colorado Health System, Denver, Colorado, 80262, United States; Recruiting
Scott Heese 303-315-2185 scott.heese@uchsc.edu
James Trotter, MD, Principal Investigator
Igal Kam, MD, Sub-Investigator
Illinois
Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Patrice Al-Saden, RN 312-695-1415 palsaden@northwestern.edu
Michael Abecassis, MD, Principal Investigator
Andreas Blei, MD, Sub-Investigator
New York
Columbia University, New York, New York, 10032, United States; Recruiting
David Zimmerman 212-305-3839 dz2011@columbia.edu
Jean Emond, MD, Principal Investigator
Robert S Brown, MD, Sub-Investigator
North Carolina
University of North Carolina, Chapel Hill, North Carolina, 27599-7210, United States; Recruiting
Carrie Nielsen 919-966-8227 carrie_nielsen@med.unc.edu
Roshan Shrestha, MD, Principal Investigator
Jeffrey Fair, MD, Sub-Investigator
Pennsylvania
Univerisity of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Mary Kaminski, PA 215-662-4302 mary.kaminski@upenn.edu
Abraham Shaked, MD, Principal Investigator
Kim Olthoff, MD, Sub-Investigator
Virginia
University of Virginia, Charlottesville, Virginia, 22908-0708, United States; Recruiting
Jaye Davis, RN 434-982-1753 jbd3g@virginia.edu
Carl L Berg, MD, Principal Investigator
Timothy Pruett, MD, Sub-Investigator
Virginia Commonwealth University, Richmond, Virginia, 23219, United States; Recruiting
Cheryl Rodgers, RN 804-828-2463 cmrodgers@mail1.vcu.edu
Robert A Fisher, MD, Principal Investigator
Mitchell Shiffman, MD, Sub-Investigator
Study chairs or principal investigators Robert M Merion, MD, Study Chair, University of Michigan - A2ALL Data Coordinating Center
Carl L Berg, MD, Study Chair, University of Virginia Health System
Jean Emond, MD, Study Chair, Columbia University
More Information Adult-to-Adult Living Donor Liver Transplantation Cohort Study Study ID Numbers: A2ALL; 1 UO1 DK62498-01
Record last reviewed: November 2004
Last Updated: November 12, 2004
Record first received: November 12, 2004
ClinicalTrials.gov Identifier: NCT00096733
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-02-11
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
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