Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069416
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Manar Salah, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment
Hcc Procedure: living donor liver transplantation

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria in High Prevalence Young HCC Patients Country.
Actual Study Start Date : January 2004
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group I
175 patients who fall within the Milan criteria.
Procedure: living donor liver transplantation
liver graft from a living donor

Group II
36 patients who fall within up-to-7 criteria
Procedure: living donor liver transplantation
liver graft from a living donor

Group III
30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC).
Procedure: living donor liver transplantation
liver graft from a living donor




Primary Outcome Measures :
  1. HCC recurrence [ Time Frame: 3 years ]
    Recurrence of Hepatocellular carcinoma either intra-hepatic, extra-hepatic or both



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Criteria

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
Layout table for additonal information
Responsible Party: Manar Salah, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT04069416    
Other Study ID Numbers: 68954200
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manar Salah, Ain Shams University:
liver transplant
HCC
Extended milan
Living donor liver transplantation