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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04069416
• Collaborator: (none)
• Enrollment: 241
• Actual Duration (Months): 180

Study Details

Study Description

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	Phase
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

Study Design

• 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: Jan 1, 2004
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. HCC recurrence [3 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manar Salah, Principal investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04069416
• Other Study ID Numbers: 68954200
• First Posted: Aug 28, 2019
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Manar Salah, Principal investigator, Ain Shams University: liver transplant; HCC; Extended milan; Living donor liver transplantation

Study Results

No Results Posted as of Aug 28, 2019