Hepatocellular CarcinomaNCT04576572
Comparison of Criteria for Liver Transplantation in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Liver Cancer, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Hepatocellular cancer is the 6th most common seen disease in the world and the 3rd in cancer-related deaths. Liver transplantation is the primary curative treatment of HCC, as it eliminates liver cancer and underlying cirrhosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer, Advanced Adult Hepatocellular Carcinoma
- How many people
- 424 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 30 Sep 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Between 2002 - 2020 August, patients undergone Liver Transplantation at Liver Transplant Institute of Inonu University.
Who may be able to join
- Patients undergone liver transplantation due to hepatocellular carcinoma
- Incidentally detected hepatocellular carcinoma at the explant pathology report
Who cannot join
- Patients with follow up period below 90 days
- Advanced Tumors which have lymph node positivity, main PV tumor thrombosis, adjacent tissue invasion defined by explant pathology etc.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Liver Transplantation Institute, Inonu University
Malatya, Battalgazi, 44280
About this study
Hepatocellular cancer is the 6th most common seen disease in the world and the 3rd in cancer-related deaths. Liver transplantation is the primary curative treatment of HCC, as it eliminates liver cancer and underlying cirrhosis. However, liver transplantation is not offered to every HCC patient, since advanced stage HCC patients are lost with tumor recurrence early after liver transplantation. The Milan criteria, which are accepted worldwide, are the patient selection criteria that we have to follow in cadaver-to-liver transplantation for HCC in our country. However, as the Milan criteria are very strict criteria, it pushes patients out of liver transplantation who exceed the Milan criteria but who can benefit from liver transplantation. Liver transplantation centers all over the world have declared their own criteria under the expanded Milan criteria. In our country, Malatya Criteria have been defined by İnönü University on this subject, and our studies on this subject still continue. When we scan the original articles of all these defined criteria, incomplete data are formed and therefore the strength of the criteria cannot be clearly revealed. For this reason, we aimed to analyze the results of our center and present information about the power of the criteria to the literature.
Read the detailed description
Aim: To investigate the criteria with the longest overall and disease-free survival and lowest recurrence rates in liver transplantation for hepatocellular cancer (HCC).
Introduction: When the liver transplant criteria for HCC were examined, we saw that many criteria defined in their original articles did not include the rates of extending the Milan criteria, survival and recurrence rates of non-milan patients who were within the newly defined criteria. Therefore, information on which of the criteria defined for liver transplantation in HCC extends the Milan criteria more, which has a longer survival rate and which has a lower recurrence rate is lacking. In order to eliminate this deficiency or at least to have a rough idea, we aimed to compare the results of liver transplantation, performed for HCC in our institute which is a high-volume liver transplant center, by analyzing it according to the existing defined criteria. Thus, we were able to compare the criteria in a homogeneous patient group that was formed as a result of the same inclusion and exclusion criteria in the same period of time. The highest overall and disease-free survival, the lowest recurrence rate, and the criterion that extends the Milan criteria will be introduced. In addition, this study is the first comprehensive comparison of liver transplant criteria for HCC.
Methods: Between March 2002 and July 2020, the data of 424 patients who underwent liver transplantation due to HCC at the Liver Transplantation Institute of İnönü University will be retrospectively analyzed from the prospectively recorded data bank and automation system. Tumor size, tumor number, differentiation and microscopic venous invasion data will all be recorded from the data in the explant pathology report. Since the primary aim of our study is cancer-related survival in patients who can be transplanted, 31 patients with tumor invasion outside the liver (extrahepatic portal vein tumor thrombosis, perihilar lymph node metastasis, diaphragmatic invasion etx) and 70 patients with follow-up period after liver transplantation below 90 days will be excluded from the study. The remaining 323 patients will be included in the study and their data will be analyzed. First, demographic data, tumor characteristics, overall and disease-free survival and recurrence rate of 323 HCC patients who were the study group, will be calculated, and then these patients will be divide groups according to be within or beyond the criteria, than survival and recurrence rates will be calculated. It was then examined whether these expanded criteria actually extended the Milan criteria. It was checked whether a defined Expanded criterion allowed liver transplantation for patients outside of Milan while excluding patients within Milan from liver transplantation. How far the expanded criteria expand the Milan and survival of the patients who beyond Milan but within the criteria were analyzed separately. Thus, the most useful criterion for liver transplantation in HCC treatment will be revealed.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, Advanced Adult Hepatocellular Carcinoma, Cirrhosis, Liver, Unresectable Liver Cancer, Liver Transplant Disorder
- Keywords
- Hepatic malignancy, malignancy, living donor, liver transplantation, expanded criteria, extended, liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Liver Cirrhosis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
Tumor free survival after liver transplantation
Measured: five years
Overall Survival
Overall survival after liver transplantation
Measured: five years
Tumor recurrence
Tumor recurrence following liver transplantation
Measured: 5 year
Secondary outcomes (1)
The Best Criteria
Liver Transplant criteria which has the best survivals
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start15 Jun 2020
- Primary completion30 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Inonu 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
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Ince, Inonu University
- Investigators
- Volkan Ince, MD, Principal investigator, Inonu University, Liver Transplant Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576572
- Sponsor's protocol ID
- LT-Criteria-HCC
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Criteria for Liver Transplantation in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04576572
- Acronym / sponsor ID
- LT-Criteria-HCC
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, Advanced Adult Hepatocellular Carcinoma, Cirrhosis, Liver, Unresectable Liver Cancer, Liver Transplant Disorder
- Keywords
- Hepatic malignancy, malignancy, living donor, liver transplantation, expanded criteria, extended, liver cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 6 Oct 2020 (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.
Hepatocellular cancer is the 6th most common seen disease in the world and the 3rd in cancer-related deaths. Liver transplantation is the primary curative treatment of HCC, as it eliminates liver cancer and underlying cirrhosis. However, liver transplantation is not offered to every HCC patient, since advanced stage HCC patients are lost with tumor recurrence early after liver transplantation. The Milan criteria, which are accepted worldwide, are the patient selection criteria that we have to follow in cadaver-to-liver transplantation for HCC in our country. However, as the Milan criteria are very strict criteria, it pushes patients out of liver transplantation who exceed the Milan criteria but who can benefit from liver transplantation. Liver transplantation centers all over the world have declared their own criteria under the expanded Milan criteria. In our country, Malatya Criteria have been defined by İnönü University on this subject, and our studies on this subject still continue. When we scan the original articles of all these defined criteria, incomplete data are formed and therefore the strength of the criteria cannot be clearly revealed. For this reason, we aimed to analyze the results of our center and present information about the power of the criteria to the literature.
Detailed description
Aim: To investigate the criteria with the longest overall and disease-free survival and lowest recurrence rates in liver transplantation for hepatocellular cancer (HCC).
Introduction: When the liver transplant criteria for HCC were examined, we saw that many criteria defined in their original articles did not include the rates of extending the Milan criteria, survival and recurrence rates of non-milan patients who were within the newly defined criteria. Therefore, information on which of the criteria defined for liver transplantation in HCC extends the Milan criteria more, which has a longer survival rate and which has a lower recurrence rate is lacking. In order to eliminate this deficiency or at least to have a rough idea, we aimed to compare the results of liver transplantation, performed for HCC in our institute which is a high-volume liver transplant center, by analyzing it according to the existing defined criteria. Thus, we were able to compare the criteria in a homogeneous patient group that was formed as a result of the same inclusion and exclusion criteria in the same period of time. The highest overall and disease-free survival, the lowest recurrence rate, and the criterion that extends the Milan criteria will be introduced. In addition, this study is the first comprehensive comparison of liver transplant criteria for HCC.
Methods: Between March 2002 and July 2020, the data of 424 patients who underwent liver transplantation due to HCC at the Liver Transplantation Institute of İnönü University will be retrospectively analyzed from the prospectively recorded data bank and automation system. Tumor size, tumor number, differentiation and microscopic venous invasion data will all be recorded from the data in the explant pathology report. Since the primary aim of our study is cancer-related survival in patients who can be transplanted, 31 patients with tumor invasion outside the liver (extrahepatic portal vein tumor thrombosis, perihilar lymph node metastasis, diaphragmatic invasion etx) and 70 patients with follow-up period after liver transplantation below 90 days will be excluded from the study. The remaining 323 patients will be included in the study and their data will be analyzed. First, demographic data, tumor characteristics, overall and disease-free survival and recurrence rate of 323 HCC patients who were the study group, will be calculated, and then these patients will be divide groups according to be within or beyond the criteria, than survival and recurrence rates will be calculated. It was then examined whether these expanded criteria actually extended the Milan criteria. It was checked whether a defined Expanded criterion allowed liver transplantation for patients outside of Milan while excluding patients within Milan from liver transplantation. How far the expanded criteria expand the Milan and survival of the patients who beyond Milan but within the criteria were analyzed separately. Thus, the most useful criterion for liver transplantation in HCC treatment will be revealed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between 2002 - 2020 August, patients undergone Liver Transplantation at Liver Transplant Institute of Inonu University.
Key inclusion criteria (2 listed)
- Patients undergone liver transplantation due to hepatocellular carcinoma
- Incidentally detected hepatocellular carcinoma at the explant pathology report
Key exclusion criteria (2 listed)
- Patients with follow up period below 90 days
- Advanced Tumors which have lymph node positivity, main PV tumor thrombosis, adjacent tissue invasion defined by explant pathology etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease Free Survival
Time frame: five years
Tumor free survival after liver transplantation
Overall Survival
Time frame: five years
Overall survival after liver transplantation
Tumor recurrence
Time frame: 5 year
Tumor recurrence following liver transplantation
1 secondary outcome
The Best Criteria
Time frame: 5 years
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 6 Oct 2020.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in publication
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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.
Volkan Ince, MD principal investigator
Inonu University, Liver Transplant Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cancer, run by Inonu University at 1 site in Turkey (Türkiye).
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 2 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Disease Free Survival (time frame: five years). The study lists 3 primary outcomes in all. 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 6 Oct 2020.