<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/NCT03841305</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0025</org_study_id>
    <secondary_id>UF 7595</secondary_id>
    <nct_id>NCT03841305</nct_id>
  </id_info>
  <brief_title>Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Future Liver Remnant</brief_title>
  <acronym>HYPER-LIV01</acronym>
  <official_title>Simultaneous Portal and Hepatic Vein Embolization Versus Portal Vein Embolization for Hypertrophy of the Future Liver Remnant Before Major Hepatectomy of Non-cirrhotic Liver : a Multicentric Comparative Randomized Phase II Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federation Francophone de Cancerologie Digestive</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</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>
      The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of&#xD;
      the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in&#xD;
      patient with liver metastases from colo-rectal origin considered as resectable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Portal vein embolization (PVE) has been widely used to generate hypertrophy of the&#xD;
      nonembolized lobe in patients undergoing major hepatectomy in order to prevent small-for-size&#xD;
      remnant liver resulting in post-operative liver insufficiency.&#xD;
&#xD;
      Although PVE is a safe and effective procedure, it does not always induce sufficient&#xD;
      hypertrophy of the future remnant liver (FRL) even after a long time. In case of insufficient&#xD;
      liver regeneration following PVE, some authors suggested to embolize hepatic vein(s) (Hwang,&#xD;
      Ann Surg 2009).&#xD;
&#xD;
      Interestingly, the sequential right hepatic vein embolization (HVE) after right PVE&#xD;
      demonstrated an incremental effect on the FRL. Although attractive, this approach requires&#xD;
      two different procedures and does not spare time as compared to PVE alone.&#xD;
&#xD;
      To shorten and optimize the phase of liver preparation before surgery,the so-called liver&#xD;
      venous deprivation (LVD) technique that combines both PVE and HVE during the same procedure&#xD;
      was developed.&#xD;
&#xD;
      The aim of this randomized phase II trial is to compare the percentage of change in FRL&#xD;
      volume at 3 weeks after LVD or PVE using MRI or CT-scan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 29, 2019</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>increase in volume of the future remnant liver (FRL)</measure>
    <time_frame>at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan</time_frame>
    <description>The primary outcomes is to compare the increase in volume of the future remnant liver (FRL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerance</measure>
    <time_frame>between the day of liver preparation and 90 days after surgery</time_frame>
    <description>Toxicities are evaluated according to NCI-CTCAE version 4.03 published 14 June 2010</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative mortality</measure>
    <time_frame>90 days after surgery</time_frame>
    <description>Post-operative mortality defined as any death within 90 days after surgery or within the hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative morbidity</measure>
    <time_frame>90 days after surgery</time_frame>
    <description>Post-operative morbidity defined as the percentages of grade I/II/III/IV/V complications according to Clavien-Dindo classification within the 90 days after surgery or within the hospital stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-hepatectomy liver failure</measure>
    <time_frame>between the day of the surgery and 90 days after surgery</time_frame>
    <description>Post-hepatectomy liver failure defined according to the &quot;50-50&quot; criteria or peak bilirubin &gt;7mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of non-resectability due to insufficient FRL</measure>
    <time_frame>between the day of the treatment and the day of the surgery</time_frame>
    <description>Rate of non-resectability due to insufficient FRL defined as the percentage of patients for whom resection will be not attempted due to insufficient FRL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of non-resectability due to tumor progression</measure>
    <time_frame>between the day of the treatment and the day of the surgery</time_frame>
    <description>Rate of non-resectability due to tumor progression defined as the percentage of patients for whom resection will not be attempted due to tumor progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of per-operative difficulties</measure>
    <time_frame>between the day of the surgery and 90 days after surgery</time_frame>
    <description>Rate of per-operative difficulties defined as the percentage of patients for whom per-operative difficulties are encountered by the surgeon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loos, operating time, transfusion</measure>
    <time_frame>the day of the surgery</time_frame>
    <description>Blood loss are evaluated in mL. Operating time avec evaluated in minutes and transfusion are evaluated by number of packed red blood cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>the day of the surgery</time_frame>
    <description>Rate of R0 resection defined as no microscopic tumor residual</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R1 resection rate</measure>
    <time_frame>the day of the surgery</time_frame>
    <description>Rate of R1 resection defined as the percentage of patients resected with margin &lt;1mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre and post-operative liver volumes</measure>
    <time_frame>Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery</time_frame>
    <description>Pre and post-operative liver volumes will be evaluated through CT or MRI acquisitions by calculating whole liver, tumor and FRL volumes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence-free survival</measure>
    <time_frame>90 days after surgery</time_frame>
    <description>Recurrence-free survival defined as the time from date of randomization to date of recurrence or death from their tumor. Patients alive will be censored at the date of last news.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Between the liver preparation and 90 days after surgery</time_frame>
    <description>Overall survival defined as the time from date of randomization to date of death from any cause. Patients alive will be censored at the date of last news.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pre and post-operative liver function</measure>
    <time_frame>Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery</time_frame>
    <description>Evaluation of pre and post-operative liver function will be evaluated using 99mTc mebrofenine scintigraphy through SPECT/CT acquisitions by calculating mebrofenin clearance in %/min/m² of whole liver and FRL at the same time points as CT/MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To search for biomarkers predictive of liver hypertrophy/regeneration and immune cell response</measure>
    <time_frame>The day of liver preparation, on day 1, day 2 and day 3 after liver preparation and the day of surgery</time_frame>
    <description>Biomarkers predictive of liver hypertrophy/regeneration are evaluated by blood samples and liver biopies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Liver Metastasis Colon Cancer</condition>
  <arm_group>
    <arm_group_label>portal vein embolization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liver preparation before major hepatectomy : portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>liver venous deprivation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liver preparation before major hepatectomy : Patients with the liver venous deprivation (LVD) technique that combines both PVE and hepatic vein embolization (HVE) during the same procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver preparation before major hepatectomy</intervention_name>
    <description>Simultaneous portal and hepatic vein embolization versus Portal vein embolization, also called venous deprivation OR portal vein embolization.</description>
    <arm_group_label>liver venous deprivation</arm_group_label>
    <arm_group_label>portal vein embolization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Liver metastases from colo-rectal origin considered as resectable (as validated by a&#xD;
             multidisciplinary committee with at least one senior hepatic surgeon) provided&#xD;
             sufficient FRL volume&#xD;
&#xD;
          -  Percentage of FRL volume &lt; 30%&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  General health status World Health Organisation 0,1&#xD;
&#xD;
          -  Estimated life expectancy &gt; 3 months&#xD;
&#xD;
          -  Patients whose biological parameters are :&#xD;
&#xD;
               -  Platelets ≥100,000/mm3,&#xD;
&#xD;
               -  Polynuclear neutrophils ≥ 1000/mm3,&#xD;
&#xD;
               -  Hemoglobin≥ 9g/dL (even transfused patients can be included)&#xD;
&#xD;
               -  Creatininemia &lt; 1.5 times the normal value&#xD;
&#xD;
               -  Creatinine clearance &gt; 30 milliliters (mL)/min&#xD;
&#xD;
               -  Bilirubinemia ≤ 1,5 times the normal value&#xD;
&#xD;
               -  liver transaminases ≤ 5 times the normal value&#xD;
&#xD;
               -  prothrombin rate &gt; 70%&#xD;
&#xD;
          -  Reference liver CT-Scan or MRI done during the 30 days preceding PVE or LVD.&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  National health insurance cover&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Patient with cirrhosis&#xD;
&#xD;
          -  Presence of clinical ascites&#xD;
&#xD;
          -  Ongoing participation or participation within the 21 days prior to inclusion in the&#xD;
             study in another therapeutic trial with an experimental drug&#xD;
&#xD;
          -  Serious non-stabilized disease, active uncontrolled infection or other serious&#xD;
             underlying disorder likely to prevent the patient from receiving the treatment&#xD;
&#xD;
          -  Pregnancy (betaHCG positive), breast-feeding or the absence of effective contraception&#xD;
             for women of child-bearing age&#xD;
&#xD;
          -  Contraindication for the MRI : Pacemaker or neurosensorial stimulator or implantable&#xD;
             defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous&#xD;
             structure.&#xD;
&#xD;
          -  Allergy or contra-indication to iodine contrast agents (thyrotoxicosis, allergy to the&#xD;
             active substance or excipients)&#xD;
&#xD;
          -  Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 48 hours&#xD;
&#xD;
          -  Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or&#xD;
             Plavix&#xD;
&#xD;
          -  Legal incapacity (persons in custody or under guardianship)&#xD;
&#xD;
          -  Deprived of liberty Subject (by judicial or administrative decision)&#xD;
&#xD;
          -  Impossibility to sign the informed consent document or to adhere to the medical&#xD;
             follow-up of the trial for geographical, social or psychological reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Boris GUIU, MD</last_name>
    <phone>0467337546</phone>
    <email>b-guiu@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <state>Hérault</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boris GUIU, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine Bouvier, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bordeaux University Hospital</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno LAPUYADE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Romaric Loffroy, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christian Sengel, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agnès Rode, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Léon Berard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Charles MASTIER, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Chevallier, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>APHP - Cochin hospital</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony DOHAN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>80000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Guillaume Vesselle, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Paul Brousse</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Oriana Ciacio, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Thierry BAERE</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 13, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Liver</keyword>
  <keyword>Interventional radiology</keyword>
  <keyword>Portal vein embolization</keyword>
  <keyword>Portal and hepatic vein embolization</keyword>
  <keyword>Future liver remnant</keyword>
  <keyword>Surgery</keyword>
  <keyword>Non-cirrhotic liver</keyword>
  <keyword>Liver metastases</keyword>
  <keyword>Colorectal cancer</keyword>
  <keyword>Liver Regeneration</keyword>
  <keyword>Liver resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Extracts</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03841305
org study id: RECHMPL18_0025
secondary id: UF 7595
nct id: NCT03841305
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of
      the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in
      patient with liver metastases from colo-rectal origin considered as resectable.
Portal vein embolization (PVE) has been widely used to generate hypertrophy of the
      nonembolized lobe in patients undergoing major hepatectomy in order to prevent small-for-size
      remnant liver resulting in post-operative liver insufficiency.

      Although PVE is a safe and effective procedure, it does not always induce sufficient
      hypertrophy of the future remnant liver (FRL) even after a long time. In case of insufficient
      liver regeneration following PVE, some authors suggested to embolize hepatic vein(s) (Hwang,
      Ann Surg 2009).

      Interestingly, the sequential right hepatic vein embolization (HVE) after right PVE
      demonstrated an incremental effect on the FRL. Although attractive, this approach requires
      two different procedures and does not spare time as compared to PVE alone.

      To shorten and optimize the phase of liver preparation before surgery,the so-called liver
      venous deprivation (LVD) technique that combines both PVE and HVE during the same procedure
      was developed.

      The aim of this randomized phase II trial is to compare the percentage of change in FRL
      volume at 3 weeks after LVD or PVE using MRI or CT-scan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: increase in volume of the future remnant liver (FRL)
time frame: at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan
description: The primary outcomes is to compare the increase in volume of the future remnant liver (FRL)
measure: Tolerance
time frame: between the day of liver preparation and 90 days after surgery
description: Toxicities are evaluated according to NCI-CTCAE version 4.03 published 14 June 2010
measure: Post-operative mortality
time frame: 90 days after surgery
description: Post-operative mortality defined as any death within 90 days after surgery or within the hospital stay
measure: Post-operative morbidity
time frame: 90 days after surgery
description: Post-operative morbidity defined as the percentages of grade I/II/III/IV/V complications according to Clavien-Dindo classification within the 90 days after surgery or within the hospital stay.
measure: Post-hepatectomy liver failure
time frame: between the day of the surgery and 90 days after surgery
description: Post-hepatectomy liver failure defined according to the "50-50" criteria or peak bilirubin >7mg/dL.
measure: Rate of non-resectability due to insufficient FRL
time frame: between the day of the treatment and the day of the surgery
description: Rate of non-resectability due to insufficient FRL defined as the percentage of patients for whom resection will be not attempted due to insufficient FRL
measure: Rate of non-resectability due to tumor progression
time frame: between the day of the treatment and the day of the surgery
description: Rate of non-resectability due to tumor progression defined as the percentage of patients for whom resection will not be attempted due to tumor progression.
measure: Rate of per-operative difficulties
time frame: between the day of the surgery and 90 days after surgery
description: Rate of per-operative difficulties defined as the percentage of patients for whom per-operative difficulties are encountered by the surgeon
measure: Blood loos, operating time, transfusion
time frame: the day of the surgery
description: Blood loss are evaluated in mL. Operating time avec evaluated in minutes and transfusion are evaluated by number of packed red blood cells
measure: R0 resection rate
time frame: the day of the surgery
description: Rate of R0 resection defined as no microscopic tumor residual
measure: R1 resection rate
time frame: the day of the surgery
description: Rate of R1 resection defined as the percentage of patients resected with margin <1mm
measure: Pre and post-operative liver volumes
time frame: Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery
description: Pre and post-operative liver volumes will be evaluated through CT or MRI acquisitions by calculating whole liver, tumor and FRL volumes
measure: Recurrence-free survival
time frame: 90 days after surgery
description: Recurrence-free survival defined as the time from date of randomization to date of recurrence or death from their tumor. Patients alive will be censored at the date of last news.
measure: Overall survival
time frame: Between the liver preparation and 90 days after surgery
description: Overall survival defined as the time from date of randomization to date of death from any cause. Patients alive will be censored at the date of last news.
measure: Evaluation of pre and post-operative liver function
time frame: Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery
description: Evaluation of pre and post-operative liver function will be evaluated using 99mTc mebrofenine scintigraphy through SPECT/CT acquisitions by calculating mebrofenin clearance in %/min/m² of whole liver and FRL at the same time points as CT/MRI
measure: To search for biomarkers predictive of liver hypertrophy/regeneration and immune cell response
time frame: The day of liver preparation, on day 1, day 2 and day 3 after liver preparation and the day of surgery
description: Biomarkers predictive of liver hypertrophy/regeneration are evaluated by blood samples and liver biopies
arm group label: portal vein embolization
arm group type: Active Comparator
description: Liver preparation before major hepatectomy : portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.
arm group label: liver venous deprivation
arm group type: Experimental
description: Liver preparation before major hepatectomy : Patients with the liver venous deprivation (LVD) technique that combines both PVE and hepatic vein embolization (HVE) during the same procedure.
intervention type: Procedure
intervention name: Liver preparation before major hepatectomy
description: Simultaneous portal and hepatic vein embolization versus Portal vein embolization, also called venous deprivation OR portal vein embolization.
arm group label: liver venous deprivation
arm group label: portal vein embolization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boris GUIU, MD
phone: 0467337546
email: b-guiu@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Hypertrophy
mesh term: Liver Extracts