Liver DiseasesPENOFORNCT04154696
APHP Plateform of Normothermic Perfusion for Rehabilitation of Hepatic Grafts
A study testing Liver transplantation of a graft after assessment by normothermic perfusion in people with Liver Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aimed to evaluate fatty liver grafts, considered as unsuitable for upfront liver transplantation, by using normothermic perfusion. Grafts have to be allocated to one of 3 liver transplantation centres of Paris. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Liver transplantation of a graft after assessment by normothermic perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2019to 1 Apr 2022
- Phase
- Interventional
- 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
Who may be able to join
- patients enlisted for liver transplantation for liver disease or HCC (AFP score≤ 2);
- Ongoing cotraception in women of reproductive age ;
- Patient with social security ;
- informed signed consent
Who cannot join
- Extra-hepatic tumor disease;
- Re-transplantation ;
- Pregnancy or brest-feeding;
- Patients participting in another study;
- Patients under psychiatric treatment;
- Patients under tutorship or curatorship
Trial locations and contacts
1 site in 1 country.
Marc-Antoine Allard, Dr contact
About this study
Official title: APHP Plateform for Assessement of Hepatic Grafts Initialy Discarded by Normothermic Perfusion
This study aimed to evaluate fatty liver grafts, considered as unsuitable for upfront liver transplantation, by using normothermic perfusion. Grafts have to be allocated to one of 3 liver transplantation centres of Paris. After evidence of viability while on perfusion, these grafts will be transplanted to recipients with an estimated waiting time > 6 months.
Read the detailed description
In this study, the coordinator investigator proposes to build a platform for perfusing in normothermic conditions all grafts with histologically proven macrosteatosis ≥ 30% that will be considered as unsuitable for upfront LT. These grafts have to be alloacted to one of the 3 liver transplantation centers of Assistance Publique des Hôpitaux de Paris. Eligible grafts (macrosteatosis ≥ 30%, no severe fibrosis or cirrhosis) will be shipped to the platform for normothermic perfusion. Perfusion will be started provided that cold ischemia time do not exceed 8 hours. Parameters of grafts viability (lactates, bile production, flow) will be monitored. After a minimum of 4 hours of normothermic perfusion (not exceeding 16 hours), grafts fulfilling strict criteria (homogeneous aspect of the liver without any necrotic regions, lactates < 2.5 mmol/l and continuous production of bile with at least one of the following criteria: pH of perfusate > 7.3, arterial flow > 150 ml/min and portal flow > 500 ml/min, homogeneous perfusion of the graft) will be considered suitable for transplantation. Recipient will be transferred to the operating room, and first phase of LT (i.e, laparotomy and total hepatectomy) will be started. Simultaneously, grafts will be shipped to the center of initial allocation. Perfusion will be pursued during the transport from the platform to the recipient. Recipients (≥18 years and ≤ 70 years) have to be enlisted for LT with an estimated waiting time > 6 months (i.e., MELD score < 25) and who signed an informed consent.
- Conditions
- Liver Diseases
- Being tested
- Liver transplantation of a graft after assessment by normothermic perfusion
- Keywords
- Steatotic liver graft, Liver transplantation, Normothermic perfusion
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantation of a graft after assessment by normothermic perfusionProcedure or surgery
Liver transplantation of a graft after assessment by normothermic perfusion
| Study group | Role | What they receive |
|---|---|---|
| Normothermic perfusion of a graft | Experimental | Not described Receives: Procedure: Liver transplantation of a graft after assessment by normothermic perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of grafts that can be transplanted after evaluation by normothermic perfusion (Hypothesis 50%) with a 3-year graft survival ≥ 90%
Graft survival
Measured: 3 months
Secondary outcomes (12)
Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period
Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period
Measured: 36 months
Proportion of fatty grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period eligible for normothermic perfusion
Proportion of fatty grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period eligible for normothermic perfusion
Measured: 36 months
Proportion of grafts perfused
Proportion of grafts perfused
Measured: 36 months
Proportion of grafts that were transplanted after perfusion
Proportion of grafts that were transplanted after perfusion
Measured: 36 months
Time interval until liver function recovery while on normothermic perfusion (according to viability criteria defined above)
Time interval until liver function recovery while on normothermic perfusion (according to viability criteria defined above)
Measured: 15 hours
Proportions of grafts transplanted after normotheric perfusion wthout early allograft dysfunction (according to Olthoff definition)
Proportions of grafts transplanted after normotheric perfusion wthout early allograft dysfunction (according to Olthoff definition)
Measured: one month
Time interval until liver function recovery after transplantation
Time interval until liver function recovery after transplantation
Measured: one day
One-month overall survival (without retransplantation or graft dysfunction)
One-month overall survival (without retransplantation or graft dysfunction)
Measured: one month
One -year graft survival
One -year graft survival
Measured: one year
Comparison of 3-months graft survival with a control group of graft considered as initially transplantable
Comparison of 3-months graft survival with a control group of graft considered as initially transplantable
Measured: 3 months
Waiting time between the two groups
Measured: 36 months
Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year
Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start28 Oct 2019 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Liver transplantation of a graft after assessment by normothermic perfusion
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154696
- Sponsor's protocol ID
- P170605J
- Acronym
- PENOFOR
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APHP Plateform for Assessement of Hepatic Grafts Initialy Discarded by Normothermic Perfusion
- ClinicalTrials.gov ID
- NCT04154696
- Acronym / sponsor ID
- PENOFOR / P170605J
- Conditions
- Liver Diseases
- Keywords
- Steatotic liver graft, Liver transplantation, Normothermic perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Oct 2019 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 6 Nov 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.
This study aimed to evaluate fatty liver grafts, considered as unsuitable for upfront liver transplantation, by using normothermic perfusion. Grafts have to be allocated to one of 3 liver transplantation centres of Paris. After evidence of viability while on perfusion, these grafts will be transplanted to recipients with an estimated waiting time > 6 months.
Detailed description
In this study, the coordinator investigator proposes to build a platform for perfusing in normothermic conditions all grafts with histologically proven macrosteatosis ≥ 30% that will be considered as unsuitable for upfront LT. These grafts have to be alloacted to one of the 3 liver transplantation centers of Assistance Publique des Hôpitaux de Paris. Eligible grafts (macrosteatosis ≥ 30%, no severe fibrosis or cirrhosis) will be shipped to the platform for normothermic perfusion. Perfusion will be started provided that cold ischemia time do not exceed 8 hours. Parameters of grafts viability (lactates, bile production, flow) will be monitored. After a minimum of 4 hours of normothermic perfusion (not exceeding 16 hours), grafts fulfilling strict criteria (homogeneous aspect of the liver without any necrotic regions, lactates < 2.5 mmol/l and continuous production of bile with at least one of the following criteria: pH of perfusate > 7.3, arterial flow > 150 ml/min and portal flow > 500 ml/min, homogeneous perfusion of the graft) will be considered suitable for transplantation. Recipient will be transferred to the operating room, and first phase of LT (i.e, laparotomy and total hepatectomy) will be started. Simultaneously, grafts will be shipped to the center of initial allocation. Perfusion will be pursued during the transport from the platform to the recipient. Recipients (≥18 years and ≤ 70 years) have to be enlisted for LT with an estimated waiting time > 6 months (i.e., MELD score < 25) and who signed an informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Liver transplantation of a graft after assessment by normothermic perfusion
| Arm | Type | Receives |
|---|---|---|
| Normothermic perfusion of a graft | Experimental | Procedure: Liver transplantation of a graft after assessment by normothermic perfusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients enlisted for liver transplantation for liver disease or HCC (AFP score≤ 2);
- Ongoing cotraception in women of reproductive age ;
- Patient with social security ;
- informed signed consent
Key exclusion criteria (6 listed)
- Extra-hepatic tumor disease;
- Re-transplantation ;
- Pregnancy or brest-feeding;
- Patients participting in another study;
- Patients under psychiatric treatment;
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 |
|---|---|---|
| Liver transplantation of a graft after assessment by normothermic perfusionLiver transplantation of a graft after assessment by normothermic perfusion | Procedure or surgery | Normothermic perfusion of a graft |
Primary outcome
To determine the proportion of grafts that can be transplanted after evaluation by normothermic perfusion (Hypothesis 50%) with a 3-year graft survival ≥ 90%
Time frame: 3 months
Graft survival
12 secondary outcomes
Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period
Time frame: 36 months
Proportion of fatty grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period eligible for normothermic perfusion
Time frame: 36 months
Proportion of grafts perfused
Time frame: 36 months
Proportion of grafts that were transplanted after perfusion
Time frame: 36 months
Time interval until liver function recovery while on normothermic perfusion (according to viability criteria defined above)
Time frame: 15 hours
Proportions of grafts transplanted after normotheric perfusion wthout early allograft dysfunction (according to Olthoff definition)
Time frame: one month
Time interval until liver function recovery after transplantation
Time frame: one day
One-month overall survival (without retransplantation or graft dysfunction)
Time frame: one month
One -year graft survival
Time frame: one year
Comparison of 3-months graft survival with a control group of graft considered as initially transplantable
Time frame: 3 months
Waiting time between the two groups
Time frame: 36 months
Incidence of biliary stenosis (anastomotic or non anastomotic) defined by cholangio MRI at one year
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Marc-Antoine Allard, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver transplantation of a graft after assessment by normothermic perfusion in people with Liver Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Nov 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact René ADAM, Pr (+ 33 1 45 59 30 49, rene.adam@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the proportion of grafts that can be transplanted after evaluation by normothermic perfusion (Hypothesis 50%) with a 3-year graft survival ≥ 90% (time frame: 3 months). 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 Nov 2019.