Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria

August 23, 2019 updated by: Manar Salah, Ain Shams University

Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria in High Prevalence Young HCC Patients Country.

The present study aims to evaluate the impact of expanding criteria beyond Milan on tumor recurrence and patient survival that will help identify the best selection criteria for HCC transplanted patients.

Study Overview

Status

Completed

Conditions

Detailed Description

Introduction:

HEPATOCELLULAR CARCINOMA (HCC) is the second leading cause of cancer mortality worldwide. Living donor liver transplantation (LDLT) for HCC patients has emerged as a rewarding therapy for a cure and a successful alternative where a Deceased donor liver transplantation (DDLT) program is lacking. Therefore, trials for careful expansion to Milan criteria have been adopted.

Aim of the study:

To evaluate the impact of expanding criteria beyond Milan on tumor recurrence and patient survival that will help identify the best selection criteria for HCC transplanted patients

Study Type

Observational

Enrollment (Actual)

241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were divided according to the pre-transplant radiological findings of HCC nodules number and sizes into 3 groups:

Group I: comprised 175 patients who fall within the Milan criteria. Group II: included 36 patients who fall within up-to-7 criteria (the sum of the number of the tumors and diameter of the largest tumor not exceeding 7cm) Group III: included 30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC).

Description

Inclusion Criteria:

  • All patient transplanted for HCC eligible for transplant (no vascular invasion-no extra hepatic metastasis)
  • age>18y

Exclusion Criteria:

  • other etiology for liver transplant rather than HCC
  • patient not fit for surgery
  • age >70y

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
175 patients who fall within the Milan criteria.
liver graft from a living donor
Group II
36 patients who fall within up-to-7 criteria
liver graft from a living donor
Group III
30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC).
liver graft from a living donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCC recurrence
Time Frame: 3 years
Recurrence of Hepatocellular carcinoma either intra-hepatic, extra-hepatic or both
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2004

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 68954200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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