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Adult-to-Adult Living Donor Liver Transplantation Cohort Study


N/A
18 Years
N/A
Not Enrolling
Both
Cirrhosis, Hepatitis C, Hepatocellular Carcinoma

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Trial Information

Adult-to-Adult Living Donor Liver Transplantation Cohort Study


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.

Inclusion 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

Inclusion Criteria - Potential Donors:

- Meet donor criteria of the transplant center

- Age >= 18 years old at donation

- Be evaluated with a history and physical examination at the transplant center

- Potential donor's recipient listed for single organ (liver) transplantation

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Survival of the potential liver transplant recipient

Outcome Description:

Time from evaluation of a living liver donor until death of the potential recipient, to test the benefit of living liver donation.

Outcome Time Frame:

Time from living donor evaluation to death

Safety Issue:

Yes

Principal Investigator

Robert M Merion, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan - A2ALL Data Coordinating Center

Authority:

United States: Federal Government

Study ID:

A2ALL (IND)

NCT ID:

NCT00096733

Start Date:

October 2004

Completion Date:

August 2010

Related Keywords:

  • Cirrhosis
  • Hepatitis C
  • Hepatocellular Carcinoma
  • Living donors
  • Organ procurement
  • Liver transplantation
  • Hepatitis C
  • Hepatocellular carcinoma
  • Hepatectomy
  • Liver regeneration
  • Graft rejection
  • Quality of life
  • Informed consent
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular

Name

Location
University of Virginia Charlottesville, Virginia  22908
Columbia University New York, New York  10032-3784
University of California Los Angeles Los Angeles, California  90095-6951
University of North Carolina Chapel Hill, North Carolina  27599
University of Pennsylvania Philadelphia, Pennsylvania  19104
University of California San Francisco San Francisco, California  941104206
Northwestern University Chicago, Illinois  60611
Virginia Commonwealth University Richmond, Virginia  
University of Colorado Health System Denver, Colorado  80262