NCT04069416

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

11.9 years

First QC Date

August 23, 2019

Last Update Submit

August 23, 2019

Conditions

Hcc

Keywords

liver transplantHCCExtended milanLiving donor liver transplantation

Outcome Measures

Primary Outcomes (1)

  • HCC recurrence

    Recurrence of Hepatocellular carcinoma either intra-hepatic, extra-hepatic or both

    3 years

Study Arms (3)

Group I

175 patients who fall within the Milan criteria.

Procedure: living donor liver transplantation

Group II

36 patients who fall within up-to-7 criteria

Procedure: living donor liver transplantation

Group III

30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC).

Procedure: living donor liver transplantation

Interventions

living donor liver transplantationPROCEDURE

liver graft from a living donor

Group IGroup IIGroup III

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

January 1, 2004

Primary Completion

December 1, 2015

Study Completion

January 1, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL