Liver CarcinomaNCT06720675
Ex-vivo Hypotermic Perfusion in Patients With Hepatocellular Carcinoma to Reduce the Incidence of Tumor Recurrence
An observational study of Liver Carcinoma and Liver Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This is a retrospective study of single-center cohorts that involves patients with HCC who underwent liver transplantation between January 2016 and 2021, who received livers preserved with Hypothermic Oxygenated Perfusion (HOPE) or Static Cold Storage (SCS) with a minum follow up of 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Carcinoma, Liver Transplant, Tumor Recurrence
- What is being tested?
- Hypothermic Oxygented Perfusion and Static Cold Storage
- Type of treatment
- Surgery or procedure
- How many people
- 237 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2022to 8 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All HCC patients transplanted between January 2016 and 2021 who received liver grafts preserved with HOPE or SCS and minimum 12 months of follow-up will be included in the study. The diagnosis of HCC was confirmed in accordance with the recommendations of international guidelines issued during the period corresponding to the diagnosis. Of these patients, demographic data, clinical parameters, laboratory data and cancer parameters will be collected, including the number of tumors, size, maximum diameter, total tumor diameter, satellite nodules, microvascular invasion, the grade, classification and stage of the tumour. Donor characteristics and post-transplant clinical data of recipients will be collected too.
Who may be able to join
- Recipients aged 18 years or older with previous diagnosis of HCC, undergone Liver Transplantation at the Transplant Center of the IRCCS AOUBO between January 2016 and 2021
- Patients who have given informed consent to participate in the study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
Official title: Use of Ex-vivo Hypotermic Perfusion in Patients With Hepatocellular Carcinoma Candidates for Liver Transplant to Reduce the Incidence of Tumor Recurrence
This is a retrospective study of single-center cohorts that involves patients with HCC who underwent liver transplantation between January 2016 and 2021, who received livers preserved with Hypothermic Oxygenated Perfusion (HOPE) or Static Cold Storage (SCS) with a minum follow up of 12 months.
Read the detailed description
The gold standard treatment for Hepatocellular Carcinoma (HCC) is Liver Transplantation (LT) but, despite its success, it maintains cancer recurrence rates of 16%. Ischemia-reperfusion injury (IRI) is considered a major determinant of the higher rate of HCC recurrence associated with transplantation from ECD donors and/or organs with ischemic damage. In this field, the treatment with Machines Perfusion (MP) of the liver has gained increasing attention in the transplant community as a useful tool to relieve IRI, test the hepatic function before transplantation and potentially reconditioning the marginal organs. The current study aims to show that Hypothermic Oxygenated Perfusion (HOPE) can protect recipients not only from IRI and post-transplant complications but also from tumour recurrence, which appears to be inevitably linked to the quality of the organ. This will be done through the comparison between a retrospective group of patients with HCC who have undergone LT with graft preserved by HOPE and a retrospective group of HCC recipients who received grafts preserved without perfusion, but with Static Cold Storage (SCS) technique.
- Conditions
- Liver Carcinoma, Liver Transplant, Tumor Recurrence, Hepato Cellular Carcinoma (HCC), Hypothermic Oxygenated Machine Perfusion
- Being tested
- Hypothermic Oxygented Perfusion, Static Cold Storage
- Keywords
- Ex-vivo machine perfusion, Hepato Cellular Carcinoma - HCC, Liver Transplantation - LT, HCC recurrence after LT, Hypothermic Oxygenated Perfusion - HOPE
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermic Oxygented PerfusionProcedure or surgery
HOPE start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid (cold Belzer MPS solution) during back-table preparation. Hepatic perfusion was performed through the vein leads to a pressure of 3-5 mmHg. Organ were treated with continuous HOPE until transplant and the perfusion was continuously monitored and data downloaded in a USB memory.
Static Cold StorageProcedure or surgery
Liver grafts are stored in sterile organ bags with cold Belzer or Celsior solution and kept in ice at 4°C.
| Study group | Role | What they receive |
|---|---|---|
| SCS - Static Clod Storage | HCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with SCS and a minimum follow-up of 12 months. Receives: Procedure: Static Cold Storage | |
| HOPE - Hypothermic Oxynated Perfusion | HCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with HOPE and a minimum follow-up of 12 months. Receives: Procedure: Hypothermic Oxygented Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of HCC tumour recurrence
For the purposes of descriptive analyses, categorical variables will be expressed as frequency and percentage; continuous variables will be expressed as mean + standard deviation (SD) or with median and inter-quartile range (IQR) depending on their distributive form. Comparisons between the two groups will be made by means of Chi-Quadro tests or Fisher's test (categorical variables), t-tests or Mann-Whitney tests (means of continuous variables, depending on their type of distribution). Multiple logistic regression models will be used to identify factors associated with the appearance of tumour recurrence, in which the graft preservation method is considered as a risk factor and the main characteristics of recipient and donor are included as potential confounders. Survival analysis using Kaplan-Meier curves, log-rank test and Cox regression will be performed to assess the time between transplantation and recurrence and the factors associated with it.
Measured: From liver transplant to twelve months after LT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start3 Jun 2022
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 237 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Ravaioli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720675
- Sponsor's protocol ID
- HCC-HOPE_2021
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dajti G, Germinario G, Prosperi E, Siniscalchi A, Vasuri F, Valente S, Odaldi F, Maroni L, Serenari M, Bertuzzo V, Laurenzi A, Del Gaudio M, Cescon M, Ravaioli M. The role of cold ischemia time and hypothermic perfusion in predicting early hepatocellular carcinoma recurrences after liver transplantation. Artif Organs. 2024 Jun;48(6):619-625. doi: 10.1111/aor.14715. Epub 2024 Jan 25.
PubMed 38270476
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ex-vivo Hypotermic Perfusion in Patients With Hepatocellular Carcinoma Candidates for Liver Transplant to Reduce the Incidence of Tumor Recurrence
- ClinicalTrials.gov ID
- NCT06720675
- Acronym / sponsor ID
- HCC-HOPE_2021
- Conditions
- Liver Carcinoma, Liver Transplant, Tumor Recurrence, Hepato Cellular Carcinoma (HCC), Hypothermic Oxygenated Machine Perfusion
- Keywords
- Ex-vivo machine perfusion, Hepato Cellular Carcinoma - HCC, Liver Transplantation - LT, HCC recurrence after LT, Hypothermic Oxygenated Perfusion - HOPE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 6 Dec 2024 (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.
This is a retrospective study of single-center cohorts that involves patients with HCC who underwent liver transplantation between January 2016 and 2021, who received livers preserved with Hypothermic Oxygenated Perfusion (HOPE) or Static Cold Storage (SCS) with a minum follow up of 12 months.
Detailed description
The gold standard treatment for Hepatocellular Carcinoma (HCC) is Liver Transplantation (LT) but, despite its success, it maintains cancer recurrence rates of 16%. Ischemia-reperfusion injury (IRI) is considered a major determinant of the higher rate of HCC recurrence associated with transplantation from ECD donors and/or organs with ischemic damage. In this field, the treatment with Machines Perfusion (MP) of the liver has gained increasing attention in the transplant community as a useful tool to relieve IRI, test the hepatic function before transplantation and potentially reconditioning the marginal organs. The current study aims to show that Hypothermic Oxygenated Perfusion (HOPE) can protect recipients not only from IRI and post-transplant complications but also from tumour recurrence, which appears to be inevitably linked to the quality of the organ. This will be done through the comparison between a retrospective group of patients with HCC who have undergone LT with graft preserved by HOPE and a retrospective group of HCC recipients who received grafts preserved without perfusion, but with Static Cold Storage (SCS) technique.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCS - Static Clod Storage | – | Procedure: Static Cold StorageHCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with SCS and a minimum follow-up of 12 months. |
| HOPE - Hypothermic Oxynated Perfusion | – | Procedure: Hypothermic Oxygented PerfusionHCC patients transplanted between January 2016 and 2021, who received liver grafts preserved with HOPE and a minimum follow-up of 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HCC patients transplanted between January 2016 and 2021 who received liver grafts preserved with HOPE or SCS and minimum 12 months of follow-up will be included in the study. The diagnosis of HCC was confirmed in accordance with the recommendations of international guidelines issued during the period corresponding to the diagnosis. Of these patients, demographic data, clinical parameters, laboratory data and cancer parameters will be collected, including the number of tumors, size, maximum diameter, total tumor diameter, satellite nodules, microvascular invasion, the grade, classification and stage of the tumour. Donor characteristics and post-transplant clinical data of recipients will be collected too.
Key inclusion criteria (2 listed)
- Recipients aged 18 years or older with previous diagnosis of HCC, undergone Liver Transplantation at the Transplant Center of the IRCCS AOUBO between January 2016 and 2021
- Patients who have given informed consent to participate in the study
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Hypothermic Oxygented PerfusionHOPE start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid (cold Belzer MPS solution) during back-table preparation. Hepatic perfusion was performed through the vein leads to a pressure of 3-5 mmHg. Organ were treated with continuous HOPE until transplant and the perfusion was continuously monitored and data downloaded in a USB memory. | Procedure or surgery | HOPE - Hypothermic Oxynated Perfusion |
| Static Cold StorageLiver grafts are stored in sterile organ bags with cold Belzer or Celsior solution and kept in ice at 4°C. | Procedure or surgery | SCS - Static Clod Storage |
Primary outcome
Risk of HCC tumour recurrence
Time frame: From liver transplant to twelve months after LT
For the purposes of descriptive analyses, categorical variables will be expressed as frequency and percentage; continuous variables will be expressed as mean + standard deviation (SD) or with median and inter-quartile range (IQR) depending on their distributive form. Comparisons between the two groups will be made by means of Chi-Quadro tests or Fisher's test (categorical variables), t-tests or Mann-Whitney tests (means of continuous variables, depending on their type of distribution). Multiple logistic regression models will be used to identify factors associated with the appearance of tumour recurrence, in which the graft preservation method is considered as a risk factor and the main characteristics of recipient and donor are included as potential confounders. Survival analysis using Kaplan-Meier curves, log-rank test and Cox regression will be performed to assess the time between transplantation and recurrence and the factors associated with it.
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 30 Jan 2025.
- Results publication: PubMed 38270476Dajti G, Germinario G, Prosperi E, Siniscalchi A, Vasuri F, Valente S, Odaldi F, Maroni L, Serenari M, Bertuzzo V, Laurenzi A, Del Gaudio M, Cescon M, Ravaioli M. The role of cold ischemia time and hypothermic perfusion in predicting early hepatocellular carcinoma recurrences after liver transplantation. Artif Organs. 2024 Jun;48(6):619-625. doi: 10.1111/aor.14715. Epub 2024 Jan 25.
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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.
Matteo Ravaioli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Liver Carcinoma and Liver Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 1 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 30 Jan 2025. 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 Italy. 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?
Risk of HCC tumour recurrence (time frame: From liver transplant to twelve months after LT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06720675, which also lists 1 linked publication.
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 30 Jan 2025.