Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits

September 4, 2013 updated by: Iman Fawzy Montasser, Ain Shams University
Within community with high incidence of HCC, stretching the limits could be justified based on tumor characters and its biological behavior

Study Overview

Status

Completed

Conditions

Detailed Description

590 Egyptian patients underwent LDLT; of them, 172 (32%) patients were transplanted for HCC. Twenty six cases (15.1%) were excluded due to early postoperative mortality (n=22) or due to non HCC related mortality (n=4). One hundred forty six patients were retrospectively reviewed to determine prognostic factors for recurrence.

Study Type

Observational

Enrollment (Actual)

590

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo,, Egypt
        • Ain Shams Center For Organ Transplantation (ASCOT),Ain Shams university

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

18 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Egyptien Patient with HCC who underwent LDLT

Description

Inclusion Criteria:

  • Egyptien Patients with HCC
  • Patients within Milan Criteria
  • Patients beyond Milan criteria are selected on a case by case basis until 2005. From 2005 , patients beyond Milan criteria are subjected to down staging protocol and then reassessed (pre transplantation local ablative therapy either with RFA or TACE according to the size and the site of the lesion and we wait for 12 weeks after ablation ,only those with well ablated lesions, decreased AFP and no denovo lesions were transplanted).

Exclusion Criteria:

  • • Evidence of macro vascular invasion by CT portography and/or US duplex.

    • Metastatic HCC
    • General contraindications for LT (ongoing sepsis, other major co morbidities,…).
    • Early postoperative mortality (first1 month).
    • Post transplant mortality during the period of follow up due to any cause other than recurrent HCC (e.g. sepsis, rejection, cardiological or cerebrovascular complications…)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of Hepatocellular carcinoma after LDLT
Time Frame: at least 6 months
at least 6 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

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

January 1, 2002

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 9, 2013

Study Record Updates

Last Update Posted (Estimate)

September 9, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hepatocellular carcinaoma

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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