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Completed

NCT Number: NCT00096733

Adult-to-Adult Living Donor Liver Transplantation Study

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.

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Key information

Conditions

Cirrhosis Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases Digestive System Diseases Digestive System Neoplasms Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Hepatocellular Carcinoma Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Los Angeles, Los Angeles, California, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Survival of the potential liver transplant recipient

    Time frame: Time from living donor evaluation to death

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

Secondary outcomes

  1. Recipient survival from time of transplant (either living or deceased donor)

    Time frame: From transplant until death or last follow-up

    Recipient survival from transplant to death. The goal is to compare survival among living donor versus deceased donor recipients.

Other outcomes

  1. Donor complications

    Time frame: From the time of donation until last follow-up

    Donor complications are recorded, and graded using the Clavien scale.

  2. Recipient complications

    Time frame: From time of transplantation until last follow-up

    Recipient complications are recorded, and graded using the Clavien scale.

Sponsors and collaborators

Lead sponsor

Arbor Research Collaborative for Health

Other

Collaborators

  • American Society of Transplant Surgeons
  • Health Resources and Services Administration (HRSA)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Adult-to-Adult Living Donor Liver Transplantation Cohort Study

Acronym: A2ALL-1

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Nov 15, 2004
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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