Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt

December 8, 2016 updated by: Iman Fawzy Montasser, Ain Shams University

Loco-regional Treatment for HCC Patients

This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver Transplantation in patients with HCC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria (68.97%) & 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.

Study Type

Observational

Enrollment (Actual)

29

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Egyptian patients prepared for living donor liver transplantation , at Ain Shams Centre for Organ Transplantation (ASCOT) , Cairo Egypt

Description

Inclusion Criteria:

  1. Adult patients 18-65 years
  2. Patients transplanted for HCC within Milan and UCSF criteria who underwent pre transplant bridge or down staging treatment for HCC

Exclusion Criteria:

  1. Tumor progression on the waiting list
  2. Vascular invasion by imaging studies
  3. Extrahepatic or lymph node metastasis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC patients
29 HCC patients who had loco regional therapies for HCC were analyzed. Twenty patients met the Milan criteria (68.97%) & 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.
Procedure: loco regional therapies for HCC
29 HCC patients received locoregonal therapy as a bridging therapy for those who were within milan and as downstaging for those were initially beyond milan. The main LRT types used for our patients were TACE and or RFA and microwave ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation
Time Frame: 3 months
the success of loco-regional therapy for hepatocellular carcinoma in term of radiological complete or partial response in the last spiral triphasic abdominal CT and /or MRI before transpalantation
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the degree of accuracy between the last CT/ MRI and the pathology of explant in term of number , size and ablation (complete necrosis ) for HCC
Time Frame: 3 months
  1. presence of viable tumour tissue in the explant pathology,
  2. mictro vascular invasion
  3. capsular or lymph node invasion the degree of accuracy between the last CT/ MRI and the pathology of explant
3 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

December 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

December 4, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC and liver transplantation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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