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/NCT05971069</url>
    </required_header>
    <id_info>
      <org_study_id>3-2021-0376</org_study_id>
      <nct_id>NCT05971069</nct_id>
    </id_info>
    <brief_title>Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging</brief_title>
    <official_title>Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging: Prospective Study to Develop Decision Algorithm to Define the Preservation/Ligation of an Aberrant Left Hepatic Artery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gangnam Severance Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gangnam Severance Hospital</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>
        &quot; Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic&#xD;
        artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation&#xD;
        should consider the oncologic safety and liver-related complication. Theoretically, the ALHA&#xD;
        preservation is the most ideal in the aspect of liver function protection. However, it is&#xD;
        technically difficult which consumes much time. Not only that, oncologic safety could be&#xD;
        threatened as some soft tissues, including lymph nodes, could be remained while in preserving&#xD;
        the ALHA.&#xD;
  &#xD;
        There has been no standardized method to evaluate the ALHA, and to decide whether preserve or&#xD;
        ligate it.&#xD;
  &#xD;
        This prospective study has been designed to develop the decision algorithm to define the ALHA&#xD;
        preservation/ligation, using near-infrared fluorescence imaging during surgery. &quot;&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 17, 2021</start_date>
    <completion_date type="Actual">June 12, 2023</completion_date>
    <primary_completion_date type="Actual">June 12, 2023</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Enrolled patients will be divided into three groups according to the real time near-infrared fluorescence imaging during surgery.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging</measure>
      <time_frame>Real time near-infrared fluorescence image will be obtained during the surgery.</time_frame>
      <description>Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging.&#xD;
  The order of the algorithm is as follows:&#xD;
  First, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed.&#xD;
  After that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging.&#xD;
  The ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)</measure>
      <time_frame>Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.</time_frame>
      <description>The elevated proprtion of the serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) compared to preoperative value will be calculated and compared by groups.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Stomach Neoplasm</condition>
    <arm_group>
      <arm_group_label>Group1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Group1</intervention_name>
      <description>Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery</description>
      <arm_group_label>Group1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Group2</intervention_name>
      <description>Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery</description>
      <arm_group_label>Group2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Group3</intervention_name>
      <description>No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery</description>
      <arm_group_label>Group3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery&#xD;
  &#xD;
            2. Patients aged between 20 to 80&#xD;
  &#xD;
            3. Patients with an ECOG 0 or 1&#xD;
  &#xD;
            4. Patients who were confirmed the presence of aberrant left hepatic artery before or&#xD;
               during surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with abnormal liver function test befor surgery&#xD;
  &#xD;
            2. Patients who diagnosed liver cirrhosis or infectious liver disease&#xD;
  &#xD;
            3. Patients who underwent liver resection, or chemotherapy for gastric cancer&#xD;
  &#xD;
            4. Patients planned for combined liver resection or cholecystectomy during gastrectomy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>GangnamSeverance Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 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>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
      <investigator_full_name>In Gyu Kwon</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</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/NCT05971069
  org study id: 3-2021-0376
  nct id: NCT05971069
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  " Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic
        artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation
        should consider the oncologic safety and liver-related complication. Theoretically, the ALHA
        preservation is the most ideal in the aspect of liver function protection. However, it is
        technically difficult which consumes much time. Not only that, oncologic safety could be
        threatened as some soft tissues, including lymph nodes, could be remained while in preserving
        the ALHA.
  
        There has been no standardized method to evaluate the ALHA, and to decide whether preserve or
        ligate it.
  
        This prospective study has been designed to develop the decision algorithm to define the ALHA
        preservation/ligation, using near-infrared fluorescence imaging during surgery. "
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  masking description: Enrolled patients will be divided into three groups according to the real time near-infrared fluorescence imaging during surgery.
  measure: The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging
  time frame: Real time near-infrared fluorescence image will be obtained during the surgery.
  description: Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging.
  The order of the algorithm is as follows:
  First, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed.
  After that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging.
  The ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm.
  measure: Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)
  time frame: Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.
  description: The elevated proprtion of the serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) compared to preoperative value will be calculated and compared by groups.
  arm group label: Group1
  arm group type: Experimental
  description: Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
  arm group label: Group2
  arm group type: Experimental
  description: Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
  arm group label: Group3
  arm group type: Experimental
  description: No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
  intervention type: Procedure
  intervention name: Group1
  description: Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
  arm group label: Group1
  intervention type: Procedure
  intervention name: Group2
  description: Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
  arm group label: Group2
  intervention type: Procedure
  intervention name: Group3
  description: No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
  arm group label: Group3
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Gangnam Severance Hospital
  investigator full name: In Gyu Kwon
  investigator title: Associate Professor
  mesh term: Stomach Neoplasms