Trial Information

Prospective Database of Liver Transplantation for Hepatocellular Carcinoma

A previous retrospective study evaluated the UNOS database of liver transplant recipients
for use of total tumor volume (TTV) and alphafetoprotein (AFP) as criteria for selection of
candidates for liver transplantation. The results confirmed a prior publication
demonstrating that tumors modestly beyond Milan size limitation and irrespective of tumor
numbers can achieve excellent outcomes, while providing important insight into which tumors
within Milan criteria remain with a high likelihood of recurrence (high AFP). The work has
now been published in Hepatology.

The investigators propose a prospective evaluation of these composite criteria, using data
from patients receiving a liver transplant in order to have a larger population. Centers
will continue to transplant according to their own criteria for inclusion on the waiting
list. Data will be gathered prospectively through a web-based database (Quickbase, Intuit)
and outcomes analyzed yearly for 5 years follow-up for tumour recurrence and patient
survival.

Each center will be responsible to enter a short list of data points for their patients at
time of listing, time of transplant, and yearly post transplant. Data points have been kept
to a minimum in the hope that this will encourage participation in this database.

The database will be set up with 3 levels of access:

1. data entry only (one at each site)

2. review site data and composite data from other sites(one at each site)

3. review all sites and aggregate (for analysis and publication) Sites will only be able
to edit and review their own patient data. They will be able to view aggregate data
from other sites from which all identifiers have been removed.

Data will not be used to manage patient care in any way. The data will be used only to
evaluate outcomes of patients who had a liver tumour at the time of their liver transplant.