xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05971628</url>
    </required_header>
    <id_info>
      <org_study_id>APHP210351</org_study_id>
      <nct_id>NCT05971628</nct_id>
    </id_info>
    <brief_title>Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma</brief_title>
    <acronym>RAPID-HCC</acronym>
    <official_title>Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a national, non-randomized, multicentric trial evaluating the feasibility and the&#xD;
        tolerance of the RAPID procedure in patients with HCC with preserved liver function requiring&#xD;
        a liver transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In France, the liver transplant allocation is based on the severity of liver failure, but&#xD;
        patients with hepatocellular carcinoma (HCC) usually do not have hepatocellular failure,&#xD;
        resulting in reduced access to liver transplantation. Two years after registration on the LT&#xD;
        list, only 66% of those registered are transplanted due to tumor progression. This&#xD;
        observation leads to the paradoxical conclusion that better access to transplantation is an&#xD;
        absolute priority, but remains limited by the shortage of grafts.&#xD;
  &#xD;
        The split surgical of one graft into two grafts is the most effective way to increase the&#xD;
        number of transplantable organs. This technique is performed daily as part of pediatric TH&#xD;
        where the child receives the left lobe/liver, adapted to his morphology. However, in adults,&#xD;
        transplantation of the left lobe (segments 2+3) or of the left liver (segments 2+3+4)&#xD;
        associated with complete excision of the native liver generates a high rate of complications&#xD;
        (small-for-size syndrome) and compromises graft and recipient survival. For these reasons,&#xD;
        this type of procedure has been almost abandoned in France.&#xD;
  &#xD;
        One of the ways to increase the organ pool without risking liver failure is therefore to&#xD;
        perform an auxiliary transplant with a partial graft from an organ harvested in its entirety&#xD;
        and then shared.&#xD;
  &#xD;
        The investigators therefore wish to evaluate the feasibility and tolerance, the results and&#xD;
        the &quot;gain&quot; of grafts after a standardized RAPID procedure ( Resection And Partial LIver&#xD;
        Transplantation with Delayed Hepatectomy) allowing to transplant an adult with a left lobe&#xD;
        (very small graft) from a shared whole graft (deceased donor in brain death) , and to compare&#xD;
        the results with standard management (orthotopic HT with whole organ for HCC).&#xD;
  &#xD;
        The population is 50 major patients (in order to realize the RAPID procedure for 34 patients)&#xD;
        with HCC requiring LT according to the usual transplantability criteria, with preserved liver&#xD;
        function. The study lasts a maximum of 70 months (24 months of inclusion period, 6 months&#xD;
        between selection and inclusion, &lt;12 months between inclusion and the 1st RAPID time, 4&#xD;
        months maximum between the 2 RAPID Steps, 24 months of patient follow-up post 2nd step of&#xD;
        RAPID). The study will proceed as described below :&#xD;
  &#xD;
          -  Pre-selection, information and consent of the patient by the local team.&#xD;
  &#xD;
          -  After validation by the scientific committee of the inclusion/exclusion criteria, the&#xD;
             patient will be prioritized with the Biomedicine Agency (800 points at 6 months)&#xD;
  &#xD;
          -  If necessary, he will receive a waiting treatment for the CHC&#xD;
  &#xD;
          -  Step 1 of RAPID : During the first operation, he will have a left hepatectomy and then&#xD;
             LT with a left lobe/liver in an orthotopic position. During this operation, a treatment&#xD;
             (resection/destruction) of a possible HCC of the right liver can be proposed in order to&#xD;
             not to leave active nodule(s).&#xD;
  &#xD;
          -  Step 2 of RAPID : Within a maximum of 4 months, after graft hypertrophy, right&#xD;
             hepatectomy of the remaining native liver will be realized.&#xD;
  &#xD;
          -  The oncological and post-LT follow-up will then be no different from a standard&#xD;
             out-of-protocol patient. Standard immunosuppression&#xD;
  &#xD;
          -  At the end of the study, a comparative analysis will be made with the control group, the&#xD;
             anonymous data of which will be transmitted by the ABM.&#xD;
  &#xD;
        The expected benefits for participants are :&#xD;
  &#xD;
          -  Rapid access to LT thanks to prioritization by the Biomedicine Agency at 6 months.&#xD;
             Moreover, prioritization on the list could make it possible to limit the use of waiting&#xD;
             treatments (surgery, radiation therapy, chemoembolization, immunotherapy, etc.) with&#xD;
             non-negligible side effects/morbidity (e.g. arterial dissection jeopardizing the future&#xD;
             graft) and high costs.&#xD;
  &#xD;
          -  reduction in the risk of leaving the list, of death on the list,&#xD;
  &#xD;
          -  access to an excellent quality graft (strict donor selection criteria) while patients&#xD;
             with HCC frequently receive marginal organs, known as &quot;out of turn&quot;, in an attempt to&#xD;
             reduce their wait,&#xD;
  &#xD;
          -  possible improvement in intention-to-treat survival.&#xD;
  &#xD;
        The expected benefits for society are :&#xD;
  &#xD;
          -  Overall increase in the organ pool = partial response to the shortage of organs from&#xD;
             which all recipients will be able to benefit (reduction of waiting time),&#xD;
  &#xD;
          -  reduction of costs related to waiting treatments in CHCs (patients registered on the&#xD;
             list),&#xD;
  &#xD;
          -  reduction of costs related to hospitalization in the event of acute decompensation of&#xD;
             chronic liver disease (ACLF).&#xD;
  &#xD;
        The risks added by research :&#xD;
  &#xD;
          -  The main risk is that caused by two successive interventions, close together. The&#xD;
             international literature on orthotopic auxiliary grafting using a small graft shows that&#xD;
             the morbidity is real but the medium and long-term results are good (4 postoperative&#xD;
             deaths reported only).&#xD;
  &#xD;
          -  The risk of small for size syndrome is not ruled out in the RAPID protocol but will be&#xD;
             limited to a minimum by appropriate portal modulation measures, a surgical technique&#xD;
             refined and implemented by the experience of each center + literature, and finally&#xD;
             postoperative follow-up close.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2029</completion_date>
    <primary_completion_date type="Anticipated">October 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patient with successful RAPID procedure</measure>
      <time_frame>4 months after the second RAPID step</time_frame>
      <description>Success of the procedure will be assessed as a patient :&#xD;
  who complete the 2 steps of the procedure,&#xD;
  who had no graft resection and who is still alive 4 months later.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tolerance of the RAPID procedure</measure>
      <time_frame>from first stage of the surgical protocol and until 90 days after the second stage</time_frame>
      <description>Tolerance will be assessed with Adverse events related to the procedure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of grafts in place</measure>
      <time_frame>4 months after the first surgical step</time_frame>
      <description>Number of patients with a graft in place at 4 months after the first surgical step</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival of grafts at 2 years from liver transplantation (LT)</measure>
      <time_frame>at 2 Years from LT</time_frame>
      <description>Survival RAPID grafts considered in the event of a graft still in place Non-survival in the event of the patient's death or new LT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival of patient at 2 year after their registration on the waiting list of transplantation</measure>
      <time_frame>at 2 year after their registration on the waiting list of transplantation</time_frame>
      <description>whatever the cause of death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival of patient at 2 year after LT</measure>
      <time_frame>at 2 year after LT</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of rejection after RAPID</measure>
      <time_frame>at 2 years after the first stage of RAPID</time_frame>
      <description>Identification of histologically proven rejections within 2 years after the first stage of RAPID.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waiting time between listing on the waiting list and LT according to RAPID</measure>
      <time_frame>1 year</time_frame>
      <description>Time between registration the waiting list and TH according to RAPID (1st step)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gain of grafts</measure>
      <time_frame>70 months</time_frame>
      <description>Number of left lobes transplanted according to RAPID protocol - the number of retransplantations = organ gain obtained. Will be also analysed, the number of right livers generated and transplanted, as well as the number of complete RAPID procedures (native liver excision) will also be analyzed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of the drop-out rate between RAPID group and control group</measure>
      <time_frame>18 months</time_frame>
      <description>Drop out will be estimated by exclusion from the LT program, whatever the cause : death, worsening, transplant refusal, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of the waiting time between registration on the transplantation list and LT between RAPID group and control group</measure>
      <time_frame>up to 18 months</time_frame>
      <description>Patients who completed the 1st RAPID phase compared to the control group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of the graft survival at 2 years after LT between RAPID group and control group</measure>
      <time_frame>at 2 years after 1rst stage of RAPID</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Liver transplantation with the RAPID procedure</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Liver transplantation for hepatocellular carcinoma according to the RAPID protocol. This protocol is an auxiliary liver transplantation of a partial graft with total hepatectomy in two stages (2 successive operations).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Comparator group with standard liver transplantation (whole graft)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Orthotopic liver transplantation with whole organ from deceased donor for hepatocellular carcinoma. Data will be provided by Biomedicine Agency, following pairing rules.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>RAPID procedure</intervention_name>
      <description>RAPID procedure stands for Resection And Partial Liver Transplantation with Delayed Hepatectomy for hepatocellular carcinoma</description>
      <arm_group_label>Liver transplantation with the RAPID procedure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria (RAPID receiver)&#xD;
  &#xD;
            -  18 years ≤ age ≤ 68 years&#xD;
  &#xD;
            -  Indication of LT for HCC validated in multidisciplinary meeting&#xD;
  &#xD;
            -  AFP score ≤ 2 (15)&#xD;
  &#xD;
            -  Body mass index &lt; 30 kg/m2&#xD;
  &#xD;
            -  MELD score ≤ 15, without access to prioritization&#xD;
  &#xD;
            -  PET CT-choline and PET CT-FDG without sign of extra-hepatic localizaton&#xD;
  &#xD;
            -  Patient having been informed and able to give written consent to participate in the&#xD;
               RAPID-HCC study&#xD;
  &#xD;
            -  Validation of the patient's inclusion in the RAPID-HCC protocol by the scientific&#xD;
               committee&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  History of, liver transplant, surgical or radiological portocaval anastomosis&#xD;
  &#xD;
            -  History of major abdominal surgery (including hepatectomy)&#xD;
  &#xD;
            -  History of abdominal radiotherapy (extrahepatic)&#xD;
  &#xD;
            -  History of acute/chronic pancreatitis&#xD;
  &#xD;
            -  Expected combined transplant&#xD;
  &#xD;
            -  HCC located 1 cm away from the transection line required by the first stage&#xD;
               hepatectomy&#xD;
  &#xD;
            -  Portal or arterial thrombosis&#xD;
  &#xD;
            -  patient with a pre-graft hepatic venous pressure gradient ≥ 20mmHg&#xD;
  &#xD;
            -  Ascites (clinical or radiological) less than 5 years ago&#xD;
  &#xD;
            -  Hepatitis C viral load +&#xD;
  &#xD;
            -  Acute or chronic hepatitis B (not cured)&#xD;
  &#xD;
            -  HIV + serology&#xD;
  &#xD;
            -  Severe comorbidities, in particular severe cardiovascular or respiratory or renal&#xD;
               pathology (at the discretion of the medical-surgical team)&#xD;
  &#xD;
            -  Patient on anticoagulant treatment&#xD;
  &#xD;
            -  Patient who has received (or is due to receive) preoperative treatment with&#xD;
               radioembolization on the right side, hepatectomy or radiotherapy near the hilum&#xD;
  &#xD;
            -  Patient who received (or should receive) preoperative treatment with anti-tyrosine&#xD;
               kinase (TKI) less than three months ago&#xD;
  &#xD;
            -  Patients receiving or having received immunotherapy&#xD;
  &#xD;
          Donor selection criteria:&#xD;
  &#xD;
            -  Brain-dead donor (no living donor)&#xD;
  &#xD;
            -  18 years ≤ age ≤ 65 years&#xD;
  &#xD;
            -  Hepatic, vascular and biliary anatomy compatible with performing a split. Analysis&#xD;
               entrusted to the team that will carry out the split, and based on the scanner of the&#xD;
               donor (to be available on the Biomedicine Agency website)&#xD;
  &#xD;
            -  Biological and hepatic assessment compatible with the realization of a split, in&#xD;
               particular transaminases &lt; 4 times the normal&#xD;
  &#xD;
            -  Graft not assigned to a protocol requiring machine infusion.&#xD;
  &#xD;
            -  Serology: anti-HBc negative, anti-HCV negative&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>68 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nicolas GOLSE, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>APHP, Paul Brousse Hospital, villejuif, France</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nicolas GOLSE, Doctor</last_name>
      <phone>3306 71 28 24 03</phone>
      <email>nicolas.golse@aphp.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>AP-HP, Paul Brousse Hospital</name>
        <address>
          <city>Villejuif</city>
          <zip>94800</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicolas GOLSE, Doctor</last_name>
        <email>nicolas.golse@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>liver transplantation</keyword>
    <keyword>split</keyword>
    <keyword>auxiliary transplantation</keyword>
    <keyword>Hepatocellular Carcinoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05971628
  org study id: APHP210351
  nct id: NCT05971628
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a national, non-randomized, multicentric trial evaluating the feasibility and the
        tolerance of the RAPID procedure in patients with HCC with preserved liver function requiring
        a liver transplantation.
  In France, the liver transplant allocation is based on the severity of liver failure, but
        patients with hepatocellular carcinoma (HCC) usually do not have hepatocellular failure,
        resulting in reduced access to liver transplantation. Two years after registration on the LT
        list, only 66% of those registered are transplanted due to tumor progression. This
        observation leads to the paradoxical conclusion that better access to transplantation is an
        absolute priority, but remains limited by the shortage of grafts.
  
        The split surgical of one graft into two grafts is the most effective way to increase the
        number of transplantable organs. This technique is performed daily as part of pediatric TH
        where the child receives the left lobe/liver, adapted to his morphology. However, in adults,
        transplantation of the left lobe (segments 2+3) or of the left liver (segments 2+3+4)
        associated with complete excision of the native liver generates a high rate of complications
        (small-for-size syndrome) and compromises graft and recipient survival. For these reasons,
        this type of procedure has been almost abandoned in France.
  
        One of the ways to increase the organ pool without risking liver failure is therefore to
        perform an auxiliary transplant with a partial graft from an organ harvested in its entirety
        and then shared.
  
        The investigators therefore wish to evaluate the feasibility and tolerance, the results and
        the "gain" of grafts after a standardized RAPID procedure ( Resection And Partial LIver
        Transplantation with Delayed Hepatectomy) allowing to transplant an adult with a left lobe
        (very small graft) from a shared whole graft (deceased donor in brain death) , and to compare
        the results with standard management (orthotopic HT with whole organ for HCC).
  
        The population is 50 major patients (in order to realize the RAPID procedure for 34 patients)
        with HCC requiring LT according to the usual transplantability criteria, with preserved liver
        function. The study lasts a maximum of 70 months (24 months of inclusion period, 6 months
        between selection and inclusion, <12 months between inclusion and the 1st RAPID time, 4
        months maximum between the 2 RAPID Steps, 24 months of patient follow-up post 2nd step of
        RAPID). The study will proceed as described below :
  
          -  Pre-selection, information and consent of the patient by the local team.
  
          -  After validation by the scientific committee of the inclusion/exclusion criteria, the
             patient will be prioritized with the Biomedicine Agency (800 points at 6 months)
  
          -  If necessary, he will receive a waiting treatment for the CHC
  
          -  Step 1 of RAPID : During the first operation, he will have a left hepatectomy and then
             LT with a left lobe/liver in an orthotopic position. During this operation, a treatment
             (resection/destruction) of a possible HCC of the right liver can be proposed in order to
             not to leave active nodule(s).
  
          -  Step 2 of RAPID : Within a maximum of 4 months, after graft hypertrophy, right
             hepatectomy of the remaining native liver will be realized.
  
          -  The oncological and post-LT follow-up will then be no different from a standard
             out-of-protocol patient. Standard immunosuppression
  
          -  At the end of the study, a comparative analysis will be made with the control group, the
             anonymous data of which will be transmitted by the ABM.
  
        The expected benefits for participants are :
  
          -  Rapid access to LT thanks to prioritization by the Biomedicine Agency at 6 months.
             Moreover, prioritization on the list could make it possible to limit the use of waiting
             treatments (surgery, radiation therapy, chemoembolization, immunotherapy, etc.) with
             non-negligible side effects/morbidity (e.g. arterial dissection jeopardizing the future
             graft) and high costs.
  
          -  reduction in the risk of leaving the list, of death on the list,
  
          -  access to an excellent quality graft (strict donor selection criteria) while patients
             with HCC frequently receive marginal organs, known as "out of turn", in an attempt to
             reduce their wait,
  
          -  possible improvement in intention-to-treat survival.
  
        The expected benefits for society are :
  
          -  Overall increase in the organ pool = partial response to the shortage of organs from
             which all recipients will be able to benefit (reduction of waiting time),
  
          -  reduction of costs related to waiting treatments in CHCs (patients registered on the
             list),
  
          -  reduction of costs related to hospitalization in the event of acute decompensation of
             chronic liver disease (ACLF).
  
        The risks added by research :
  
          -  The main risk is that caused by two successive interventions, close together. The
             international literature on orthotopic auxiliary grafting using a small graft shows that
             the morbidity is real but the medium and long-term results are good (4 postoperative
             deaths reported only).
  
          -  The risk of small for size syndrome is not ruled out in the RAPID protocol but will be
             limited to a minimum by appropriate portal modulation measures, a surgical technique
             refined and implemented by the experience of each center + literature, and finally
             postoperative follow-up close.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of patient with successful RAPID procedure
  time frame: 4 months after the second RAPID step
  description: Success of the procedure will be assessed as a patient :
  who complete the 2 steps of the procedure,
  who had no graft resection and who is still alive 4 months later.
  measure: Tolerance of the RAPID procedure
  time frame: from first stage of the surgical protocol and until 90 days after the second stage
  description: Tolerance will be assessed with Adverse events related to the procedure
  measure: Proportion of grafts in place
  time frame: 4 months after the first surgical step
  description: Number of patients with a graft in place at 4 months after the first surgical step
  measure: Survival of grafts at 2 years from liver transplantation (LT)
  time frame: at 2 Years from LT
  description: Survival RAPID grafts considered in the event of a graft still in place Non-survival in the event of the patient's death or new LT
  measure: Survival of patient at 2 year after their registration on the waiting list of transplantation
  time frame: at 2 year after their registration on the waiting list of transplantation
  description: whatever the cause of death
  measure: Survival of patient at 2 year after LT
  time frame: at 2 year after LT
  measure: Incidence of rejection after RAPID
  time frame: at 2 years after the first stage of RAPID
  description: Identification of histologically proven rejections within 2 years after the first stage of RAPID.
  measure: Waiting time between listing on the waiting list and LT according to RAPID
  time frame: 1 year
  description: Time between registration the waiting list and TH according to RAPID (1st step)
  measure: Gain of grafts
  time frame: 70 months
  description: Number of left lobes transplanted according to RAPID protocol - the number of retransplantations = organ gain obtained. Will be also analysed, the number of right livers generated and transplanted, as well as the number of complete RAPID procedures (native liver excision) will also be analyzed.
  measure: Comparison of the drop-out rate between RAPID group and control group
  time frame: 18 months
  description: Drop out will be estimated by exclusion from the LT program, whatever the cause : death, worsening, transplant refusal, etc.
  measure: Comparison of the waiting time between registration on the transplantation list and LT between RAPID group and control group
  time frame: up to 18 months
  description: Patients who completed the 1st RAPID phase compared to the control group
  measure: Comparison of the graft survival at 2 years after LT between RAPID group and control group
  time frame: at 2 years after 1rst stage of RAPID
  arm group label: Liver transplantation with the RAPID procedure
  arm group type: Experimental
  description: Liver transplantation for hepatocellular carcinoma according to the RAPID protocol. This protocol is an auxiliary liver transplantation of a partial graft with total hepatectomy in two stages (2 successive operations).
  arm group label: Comparator group with standard liver transplantation (whole graft)
  arm group type: No Intervention
  description: Orthotopic liver transplantation with whole organ from deceased donor for hepatocellular carcinoma. Data will be provided by Biomedicine Agency, following pairing rules.
  intervention type: Procedure
  intervention name: RAPID procedure
  description: RAPID procedure stands for Resection And Partial Liver Transplantation with Delayed Hepatectomy for hepatocellular carcinoma
  arm group label: Liver transplantation with the RAPID procedure
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 68 Years
  healthy volunteers: No
  last name: Nicolas GOLSE, Doctor
  role: Principal Investigator
  affiliation: APHP, Paul Brousse Hospital, villejuif, France
  last name: Nicolas GOLSE, Doctor
  phone: 3306 71 28 24 03
  email: nicolas.golse@aphp.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  sharing ipd: No