<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/NCT02216773</url>
  </required_header>
  <id_info>
    <org_study_id>14/LO/1123</org_study_id>
    <nct_id>NCT02216773</nct_id>
  </id_info>
  <brief_title>Regeneration of Liver: Portal Vein Embolization Versus Radiofrequency Assisted Ligation for Liver Hypertrophy (REBIRTH)</brief_title>
  <acronym>REBIRTH</acronym>
  <official_title>Liver Regeneration: a Single-centre, Prospective, Randomised Controlled Trial Comparing Radiofrequency Assisted Liver Partition With Portal Vein Ligation (RALPP) With Portal Vein Embolization (PVE) for Preoperative Induction of Liver Hypertrophy in Patients With Insufficient Future Liver Remnant Volume for Major Liver Resection.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</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 aim of this study is to compare two different techniques (portal vein embolization and&#xD;
      radiofrequency assisted liver partition with portal vein ligation) for increasing liver&#xD;
      volume prior to major liver resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver resection remains the gold standard treatment for patients with liver tumours providing&#xD;
      them the only chance for long-term survival. In up to 45% of cases that are amenable to&#xD;
      surgical resection, an extended hepatectomy (removal of part of the liver) is usually&#xD;
      necessary to achieve a clear resection margin. However, there must be enough liver left&#xD;
      behind to meet the demands of the body. Indeed, liver failure due to insufficient remnant&#xD;
      liver volume is still the principal cause of postoperative death following a major liver&#xD;
      resection.&#xD;
&#xD;
      The liver receives its main blood supply from two vessels (the portal vein and the hepatic&#xD;
      artery). In order to decrease the complications and improve the safety of extensive liver&#xD;
      surgery in patients with insufficient future liver remnant volume (FLRV), pre-operative&#xD;
      embolization (i.e. blockage) of part of the portal vein can be undertaken.&#xD;
&#xD;
      This has the effect of inducing growth of the liver on the unaffected side. Thus, when the&#xD;
      resection is carried out, an increased FLRV (of around 12%) reduces post-operative liver&#xD;
      failure. An alternative technique is to perform surgical ligation of the portal vein along&#xD;
      with splitting of the liver.&#xD;
&#xD;
      The diseased portion of liver is left in the body for 7-10 days while the healthy side is&#xD;
      induced to grow. During this time, the diseased portion continues to support the body's&#xD;
      requirement for liver function and reduces the risk of liver failure. FLRV has been shown to&#xD;
      increase by around 74% with this technique.&#xD;
&#xD;
      However, there are more postoperative complications with the alternative technique such as&#xD;
      bile leaks. The aim of this study is to test a new way of splitting the liver so that the&#xD;
      increased FLRV can be achieved without the increased complication rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>N/A</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>Changes in Liver Remnant Volume</measure>
    <time_frame>2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)</time_frame>
    <description>Percentage change in remnant liver volume following intervention. This will be measured by volumetric analysis of CT scan. Positive number represents increases and negative number represents decreases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Liver Function Tests</measure>
    <time_frame>Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization)</time_frame>
    <description>Blood tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b)</measure>
    <time_frame>Up to hospital discharge (estimated to be between 2 and 10 days)</time_frame>
    <description>As defined by Dindo Clavien classification of surgical complications (≥grade 3b).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Liver Resection</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Portal vein embolization (PVE)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients allocated to the PVE group will receive pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They will then have their portal vein embolized radiologically once their pre-intervention investigations have been completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) will take place 4 weeks after the completion of the PVE. At this point, they will be listed to receive their definitive surgical hepatectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiofrequency assisted liver partition and ligation (RALPP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the RALPP group will receive pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They will then have their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may additionally have a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPP procedure will occur once the patient's pre-intervention investigations have been completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) will take place 2 weeks after the completion of the RALPP. At this point, they will be listed to receive their definitive surgical hepatectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency assisted liver partition with portal vein ligation (RALPP)</intervention_name>
    <arm_group_label>Radiofrequency assisted liver partition and ligation (RALPP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Portal vein embolization (PVE)</intervention_name>
    <arm_group_label>Portal vein embolization (PVE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Any patient requiring right or extended right hepatectomy with FLRV less than 25% on&#xD;
             preoperative volumetric study&#xD;
&#xD;
          -  WHO performance status 0, 1 or 2&#xD;
&#xD;
          -  Patient able to comply with protocol requirements and deemed fit for surgical&#xD;
             resection&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  WHO status 3 or 4&#xD;
&#xD;
          -  New York Heart Association Classification Grade III or IV&#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_official>
    <last_name>Long R Jiao, MD, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Gall TM, Sodergren MH, Frampton AE, Fan R, Spalding DR, Habib NA, Pai M, Jackson JE, Tait P, Jiao LR. Radio-frequency-assisted Liver Partition with Portal vein ligation (RALPP) for liver regeneration. Ann Surg. 2015 Feb;261(2):e45-6. doi: 10.1097/SLA.0000000000000607. No abstract available.</citation>
    <PMID>24670841</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>August 15, 2019</results_first_submitted>
  <results_first_submitted_qc>October 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 7, 2019</results_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Liver hypertrophy</keyword>
  <keyword>Liver resection</keyword>
  <keyword>Liver metastases</keyword>
  <keyword>Portal vein ligation</keyword>
  <keyword>Portal vein embolization</keyword>
  <keyword>Radiofrequency splitting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT02216773/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Portal Vein Embolization (PVE)</title>
          <description>Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Portal vein embolization (PVE)</description>
        </group>
        <group group_id="P2">
          <title>Radiofrequency Assisted Liver Partition and Ligation (RALPPS)</title>
          <description>Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Underwent Procedure (PVE/RALPPS)</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insufficient FLRV</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Abandoned</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Portal Vein Embolization (PVE)</title>
          <description>Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Portal vein embolization (PVE)</description>
        </group>
        <group group_id="B2">
          <title>Radiofrequency Assisted Liver Partition and Ligation (RALPPS)</title>
          <description>Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.3" spread="8.9"/>
                    <measurement group_id="B2" value="62.4" spread="10.2"/>
                    <measurement group_id="B3" value="63.3" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Liver Remnant Volume</title>
        <description>Percentage change in remnant liver volume following intervention. This will be measured by volumetric analysis of CT scan. Positive number represents increases and negative number represents decreases.</description>
        <time_frame>2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Portal Vein Embolization (PVE)</title>
            <description>Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Portal vein embolization (PVE)</description>
          </group>
          <group group_id="O2">
            <title>Radiofrequency Assisted Liver Partition and Ligation (RALPPS)</title>
            <description>Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Liver Remnant Volume</title>
          <description>Percentage change in remnant liver volume following intervention. This will be measured by volumetric analysis of CT scan. Positive number represents increases and negative number represents decreases.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" spread="9.8"/>
                    <measurement group_id="O2" value="80.7" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Liver Function Tests</title>
        <description>Blood tests</description>
        <time_frame>Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization)</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Portal Vein Embolization (PVE)</title>
            <description>Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Portal vein embolization (PVE)</description>
          </group>
          <group group_id="O2">
            <title>Radiofrequency Assisted Liver Partition and Ligation (RALPPS)</title>
            <description>Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Liver Function Tests</title>
          <description>Blood tests</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b)</title>
        <description>As defined by Dindo Clavien classification of surgical complications (≥grade 3b).</description>
        <time_frame>Up to hospital discharge (estimated to be between 2 and 10 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Portal Vein Embolization (PVE)</title>
            <description>Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Portal vein embolization (PVE)</description>
          </group>
          <group group_id="O2">
            <title>Radiofrequency Assisted Liver Partition and Ligation (RALPPS)</title>
            <description>Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b)</title>
          <description>As defined by Dindo Clavien classification of surgical complications (≥grade 3b).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>90 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Portal Vein Embolization (PVE)</title>
          <description>Patients allocated to the PVE group received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their portal vein embolized radiologically once their pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 4 weeks after the completion of the PVE. At this point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Portal vein embolization (PVE)</description>
        </group>
        <group group_id="E2">
          <title>Radiofrequency Assisted Liver Partition and Ligation (RALPPS)</title>
          <description>Patients allocated to the RALPP received pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They then had their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may also have had a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPPS procedure occurred once the patient's pre-intervention investigations were completed and reviewed by the clinical team.&#xD;
Post-intervention investigations (blood tests and CT scan) occurred 2 weeks after the completion of the RALPPS. At that point, they were listed to receive their definitive surgical hepatectomy.&#xD;
Radiofrequency assisted liver partition with portal vein ligation (RALPPS)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Postoperative complication (Dindo Clavien ≥grade 3b)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Postoperative complication (Dindo Clavien &lt;grade 3b)</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="24"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professor Long Jiao</name_or_title>
      <organization>Imperial College London</organization>
      <phone>+44 2033133937</phone>
      <email>l.jiao@imperial.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02216773
org study id: 14/LO/1123
nct id: NCT02216773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare two different techniques (portal vein embolization and
      radiofrequency assisted liver partition with portal vein ligation) for increasing liver
      volume prior to major liver resection.
Liver resection remains the gold standard treatment for patients with liver tumours providing
      them the only chance for long-term survival. In up to 45% of cases that are amenable to
      surgical resection, an extended hepatectomy (removal of part of the liver) is usually
      necessary to achieve a clear resection margin. However, there must be enough liver left
      behind to meet the demands of the body. Indeed, liver failure due to insufficient remnant
      liver volume is still the principal cause of postoperative death following a major liver
      resection.

      The liver receives its main blood supply from two vessels (the portal vein and the hepatic
      artery). In order to decrease the complications and improve the safety of extensive liver
      surgery in patients with insufficient future liver remnant volume (FLRV), pre-operative
      embolization (i.e. blockage) of part of the portal vein can be undertaken.

      This has the effect of inducing growth of the liver on the unaffected side. Thus, when the
      resection is carried out, an increased FLRV (of around 12%) reduces post-operative liver
      failure. An alternative technique is to perform surgical ligation of the portal vein along
      with splitting of the liver.

      The diseased portion of liver is left in the body for 7-10 days while the healthy side is
      induced to grow. During this time, the diseased portion continues to support the body's
      requirement for liver function and reduces the risk of liver failure. FLRV has been shown to
      increase by around 74% with this technique.

      However, there are more postoperative complications with the alternative technique such as
      bile leaks. The aim of this study is to test a new way of splitting the liver so that the
      increased FLRV can be achieved without the increased complication rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Liver Remnant Volume
time frame: 2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)
description: Percentage change in remnant liver volume following intervention. This will be measured by volumetric analysis of CT scan. Positive number represents increases and negative number represents decreases.
measure: Postoperative Liver Function Tests
time frame: Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization)
description: Blood tests
measure: Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b)
time frame: Up to hospital discharge (estimated to be between 2 and 10 days)
description: As defined by Dindo Clavien classification of surgical complications (≥grade 3b).
arm group label: Portal vein embolization (PVE)
arm group type: Active Comparator
description: Patients allocated to the PVE group will receive pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They will then have their portal vein embolized radiologically once their pre-intervention investigations have been completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) will take place 4 weeks after the completion of the PVE. At this point, they will be listed to receive their definitive surgical hepatectomy.
arm group label: Radiofrequency assisted liver partition and ligation (RALPP)
arm group type: Experimental
description: Patients allocated to the RALPP group will receive pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They will then have their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may additionally have a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPP procedure will occur once the patient's pre-intervention investigations have been completed and reviewed by the clinical team.
Post-intervention investigations (blood tests and CT scan) will take place 2 weeks after the completion of the RALPP. At this point, they will be listed to receive their definitive surgical hepatectomy.
intervention type: Procedure
intervention name: Radiofrequency assisted liver partition with portal vein ligation (RALPP)
arm group label: Radiofrequency assisted liver partition and ligation (RALPP)
intervention type: Procedure
intervention name: Portal vein embolization (PVE)
arm group label: Portal vein embolization (PVE)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Long R Jiao, MD, FRCS
role: Principal Investigator
affiliation: Imperial College London
facility: 
country: United Kingdom
citation: Gall TM, Sodergren MH, Frampton AE, Fan R, Spalding DR, Habib NA, Pai M, Jackson JE, Tait P, Jiao LR. Radio-frequency-assisted Liver Partition with Portal vein ligation (RALPP) for liver regeneration. Ann Surg. 2015 Feb;261(2):e45-6. doi: 10.1097/SLA.0000000000000607. No abstract available.
PMID: 24670841
responsible party type: Sponsor
mesh term: Hypertrophy
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 