HccNCT04069416
Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria
An observational study of Hcc, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hcc
- What is being tested?
- living donor liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- All patient transplanted for HCC eligible for transplant (no vascular invasion-no extra hepatic metastasis)
- age>18y
Who cannot join
- other etiology for liver transplant rather than HCC
- patient not fit for surgery
- age >70y
About this study
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.
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.
Read the 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
- Conditions
- Hcc
- Being tested
- living donor liver transplantation
- Keywords
- liver transplant, HCC, Extended milan, Living donor liver transplantation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
living donor liver transplantationProcedure or surgery
liver graft from a living donor
| Study group | Role | What they receive |
|---|---|---|
| Group I | 175 patients who fall within the Milan criteria. Receives: Procedure: living donor liver transplantation | |
| Group II | 36 patients who fall within up-to-7 criteria Receives: Procedure: living donor liver transplantation | |
| Group III | 30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC). Receives: Procedure: living donor liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC recurrence
Recurrence of Hepatocellular carcinoma either intra-hepatic, extra-hepatic or both
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startJan 2004
- Primary completionDec 2015
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HccStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Salah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069416
- Sponsor's protocol ID
- 68954200
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04069416
- Acronym / sponsor ID
- 68954200
- Conditions
- Hcc
- Keywords
- liver transplant, HCC, Extended milan, Living donor liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2004 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: living donor liver transplantation175 patients who fall within the Milan criteria. |
| Group II | – | Procedure: living donor liver transplantation36 patients who fall within up-to-7 criteria |
| Group III | – | Procedure: living donor liver transplantation30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- All patient transplanted for HCC eligible for transplant (no vascular invasion-no extra hepatic metastasis)
- age>18y
Key exclusion criteria (3 listed)
- other etiology for liver transplant rather than HCC
- patient not fit for surgery
- age >70y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| living donor liver transplantationliver graft from a living donor | Procedure or surgery | Group I, Group II, Group III |
Primary outcome
HCC recurrence
Time frame: 3 years
Recurrence of Hepatocellular carcinoma either intra-hepatic, extra-hepatic or both
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hcc, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC recurrence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.