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/NCT06005883</url>
    </required_header>
    <id_info>
      <org_study_id>2022-03-065-003</org_study_id>
      <nct_id>NCT06005883</nct_id>
    </id_info>
    <brief_title>Surgical Outcome of HCC With Portal Vein Tumor Thrombosis on the Basis of Risk Scoring</brief_title>
    <official_title>The Prognosis After Surgical Resection in Patients With Hepatocellular Carcinoma Combined Portal Vein Tumor Thrombosis; Multicenter Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Keimyung University Dongsan Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Keimyung University Dongsan Medical Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this multicenter retrospective cohort study is to investigate the clinical&#xD;
        outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT,&#xD;
        and to develop a prognostic index that can be helpful in determining the treatment strategy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hepatocellular carcinoma (HCC) frequently invades the surrounding liver vasculature, with&#xD;
        portal vein tumor thrombosis (PVTT) being the most common form of macrovascular invasion. At&#xD;
        the time of HCC diagnosis, PVTT is detected in approximately 10%-40% of patients and is&#xD;
        associated with an extremely poor prognosis.&#xD;
  &#xD;
        In most staging systems and guidelines, HCC with PVTT, regardless of the extent of the tumor,&#xD;
        is classified as an advanced stage, and surgical resection is not recommended as the&#xD;
        first-line treatment. Instead, consensus guidelines such as those from the American&#xD;
        Association of Study of Liver Disease(AASLD), the Asian Pacific Association for the Study of&#xD;
        Liver(APASL), and the European Association for the Study of Liver(EASL) recommend systemic&#xD;
        and targeted therapy for these patients. Despite these recommendations, experienced liver&#xD;
        centers in Asia have been attempting surgical resection for some patients with HCC exhibiting&#xD;
        PVTT, and the outcomes are favorable in selected patients. However, most of the studies were&#xD;
        conducted in only one center, had a small sample size, and obtained undesirable surgical&#xD;
        treatment outcomes in most of the patients. Thus, surgical resection has not yet been widely&#xD;
        accepted as an effective treatment for patients with HCC and PVTT. In addition, a prognostic&#xD;
        index that can indicate which surgical resection is beneficial in comparison with nonsurgical&#xD;
        treatment remains unestablished. A randomized controlled trial could be the best way to&#xD;
        compare the outcomes of surgical resection and nonsurgical treatments, but it is difficult to&#xD;
        conduct because of difficulties in ethical approval and allocation concealment. Therefore,&#xD;
        adequate studies with large sample sizes are needed to clarify the benefits of surgical&#xD;
        resection in patients with HCC and PVTT and the prognostic index, which can specify the&#xD;
        criteria for surgical resection in these patients.&#xD;
  &#xD;
        This study aimed to investigate the clinical outcomes and prognostic factors after hepatic&#xD;
        resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be&#xD;
        helpful in determining the treatment strategy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 10, 2021</start_date>
    <completion_date type="Actual">April 10, 2022</completion_date>
    <primary_completion_date type="Actual">August 10, 2021</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Death</measure>
      <time_frame>From the date of surgery until the date of patient's death from any cause, whichever came first, assessed up to November 2021.</time_frame>
      <description>Patient's death after surgical resection in HCC patients with portal vein tumor thrombosis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recurrence of tumor</measure>
      <time_frame>From the date of surgery until the date of HCC recurrence, whichever came first, assessed up to November 2021.</time_frame>
      <description>HCC recurrence after surgical resection in HCC patients with portal vein tumor thrombosis</description>
    </primary_outcome>
    <enrollment type="Actual">332</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <condition>Portal Vein Thrombosis</condition>
    <condition>Prognosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          This retrospective multicenter study enrolled patients who underwent surgical resection of&#xD;
          HCC with PVTT at 10 university-affiliated hospitals in Korea between January 2005 and&#xD;
          December 2019. The institutional review board of each study center approved the study&#xD;
          protocol (IRB No.:2022-03-065-003). The inclusion criteria were as follows: a) HCC with&#xD;
          PVTT found on preoperative imaging and proven by postoperative histology whether it is&#xD;
          viable; b) Child-Pugh class A liver function; c) no extrahepatic metastasis and concomitant&#xD;
          malignant tumors other than HCC; d) no previous hepatic resection for HCC; and e) available&#xD;
          medical records and/or imaging studies.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The patients underwent liver resection for HCC with portal vein tumor thrombosis between&#xD;
          Jan 2005 and Dec 2019 at 10 university-affiliated hospitals in South Korea.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Metastatic cancer &amp; extrahepatic metastasis&#xD;
  &#xD;
            -  Intrahepatic cholangiocarcinoma&#xD;
  &#xD;
            -  Mixed type hepatocellular-cholangiocarcinoma&#xD;
  &#xD;
            -  Recurred hepatocellular carcinoma&#xD;
  &#xD;
            -  not available medical records.&#xD;
  &#xD;
            -  Child-Pugh classification B or C&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Keimyung university Dongsan Medical Center</name>
        <address>
          <city>Daegu</city>
          <state>DalSeo-gu</state>
          <zip>42601</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hepatocellular carcinoma</keyword>
    <keyword>portal vein tumor thrombosis</keyword>
    <keyword>Prognosis</keyword>
    <keyword>Hepatectomy</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>
      <mesh_term>Thrombosis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06005883
  org study id: 2022-03-065-003
  nct id: NCT06005883
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this multicenter retrospective cohort study is to investigate the clinical
        outcomes and prognostic factors after hepatic resection in patients with HCC exhibiting PVTT,
        and to develop a prognostic index that can be helpful in determining the treatment strategy.
  Hepatocellular carcinoma (HCC) frequently invades the surrounding liver vasculature, with
        portal vein tumor thrombosis (PVTT) being the most common form of macrovascular invasion. At
        the time of HCC diagnosis, PVTT is detected in approximately 10%-40% of patients and is
        associated with an extremely poor prognosis.
  
        In most staging systems and guidelines, HCC with PVTT, regardless of the extent of the tumor,
        is classified as an advanced stage, and surgical resection is not recommended as the
        first-line treatment. Instead, consensus guidelines such as those from the American
        Association of Study of Liver Disease(AASLD), the Asian Pacific Association for the Study of
        Liver(APASL), and the European Association for the Study of Liver(EASL) recommend systemic
        and targeted therapy for these patients. Despite these recommendations, experienced liver
        centers in Asia have been attempting surgical resection for some patients with HCC exhibiting
        PVTT, and the outcomes are favorable in selected patients. However, most of the studies were
        conducted in only one center, had a small sample size, and obtained undesirable surgical
        treatment outcomes in most of the patients. Thus, surgical resection has not yet been widely
        accepted as an effective treatment for patients with HCC and PVTT. In addition, a prognostic
        index that can indicate which surgical resection is beneficial in comparison with nonsurgical
        treatment remains unestablished. A randomized controlled trial could be the best way to
        compare the outcomes of surgical resection and nonsurgical treatments, but it is difficult to
        conduct because of difficulties in ethical approval and allocation concealment. Therefore,
        adequate studies with large sample sizes are needed to clarify the benefits of surgical
        resection in patients with HCC and PVTT and the prognostic index, which can specify the
        criteria for surgical resection in these patients.
  
        This study aimed to investigate the clinical outcomes and prognostic factors after hepatic
        resection in patients with HCC exhibiting PVTT, and to develop a prognostic index that can be
        helpful in determining the treatment strategy.
  observational model: Cohort
  time perspective: Retrospective
  measure: Death
  time frame: From the date of surgery until the date of patient's death from any cause, whichever came first, assessed up to November 2021.
  description: Patient's death after surgical resection in HCC patients with portal vein tumor thrombosis
  measure: Recurrence of tumor
  time frame: From the date of surgery until the date of HCC recurrence, whichever came first, assessed up to November 2021.
  description: HCC recurrence after surgical resection in HCC patients with portal vein tumor thrombosis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Thrombosis