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/NCT05989789</url>
    </required_header>
    <id_info>
      <org_study_id>2019_02118</org_study_id>
      <nct_id>NCT05989789</nct_id>
    </id_info>
    <brief_title>Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients</brief_title>
    <official_title>Radioactive Seed-guided Resection of Cholangiocellular Carcinoma in Cirrhotic Patients - Report of Two Cases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clarunis - Universitäres Bauchzentrum Basel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clarunis - Universitäres Bauchzentrum Basel</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both&#xD;
        radiologic imaging and during surgical resection. Therefore, radioactive seed-guided&#xD;
        resection of these tumors, analogously to breast cancer, could be an interesting approach.&#xD;
        The investigators present two cases of cirrhotic patients where this method of tumor&#xD;
        labelling was used.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators selected two cases of patients with liver cirrhosis where seed-guided liver&#xD;
        resection was used. Seed-guided resection is procedure that is usually commonly used in&#xD;
        breast cancer surgery but so far not in liver surgery.&#xD;
  &#xD;
        This report emphasizes the difficulties, which surgeons and radiologists may face in tumor&#xD;
        entities that are difficult to identify both macroscopically, by palpation and intraoperative&#xD;
        imaging techniques.&#xD;
  &#xD;
        The first case was a patient suffering from suspected hepatocellular carcinoma with the&#xD;
        background of alcoholic liver cirrhosis. This patient already underwent liver surgery to&#xD;
        remove the suspected tumour but the lesion could not be removed correctly as identification&#xD;
        was not possible neither with palpation nor with the help of intraoperative ultrasound. For&#xD;
        this reason, the patient was selected for seed-guided resection.&#xD;
  &#xD;
        The second patient, who presented nine months after the first one, presented with the&#xD;
        suspicion of cirrhosis, two lesion small in size and in a surgically difficult localization.&#xD;
        Therefore, the patient was selected for seed-guided resection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 15, 2020</start_date>
    <completion_date type="Actual">June 30, 2021</completion_date>
    <primary_completion_date type="Actual">March 27, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>R0-Resection according to the tumour classification system</measure>
      <time_frame>1 week after operation</time_frame>
      <description>Removal of the tumour in healthy tissue, which means that microscopically no tumour tissue is detectable in the resection margin of the removed tissue.&#xD;
  This is always examined by a trained pathologist.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Procedure-Safety (No residual source of radiation)</measure>
      <time_frame>1 Day</time_frame>
      <description>Complete seed extraction was confirmed intraoperatively by specimen radiography immediately after tissue removal and by ensuring that no residual source of radiation is traceable in the patient with the gamma probe system.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients without side effects</measure>
      <time_frame>6 months</time_frame>
      <description>Clinical follow up of the patients to ensure that there are no side effects from implanting the Seed in the liver</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">2</enrollment>
    <condition>Liver Cancer</condition>
    <condition>Liver Cirrhosis</condition>
    <arm_group>
      <arm_group_label>Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach.&#xD;
  This report emphasizes the difficulties, which surgeons and radiologists may face in tumor entities that are difficult to identify both macroscopically, by palpation and intraoperative imaging techniques. It also highlights the successful adaption of a procedure commonly used for breast cancer surgery for liver surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Radioactive Seed Implantation</intervention_name>
      <description>In patients where initially the tumour lesion could not be identified, a radioactive seed was implanted and intraoperatively detected with a geiger counter sonde.</description>
      <arm_group_label>Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  suspect cancerous liver lesion&#xD;
  &#xD;
            -  fit for surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  emergency surgery&#xD;
  &#xD;
            -  age under 18&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Savas D Soysal, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Clarunis Basel</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University hospital</name>
        <address>
          <city>Basel</city>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Clarunis - Universitäres Bauchzentrum Basel</investigator_affiliation>
      <investigator_full_name>Savas Soysal</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholangiocarcinoma</mesh_term>
      <mesh_term>Liver Cirrhosis</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/NCT05989789
  org study id: 2019_02118
  nct id: NCT05989789
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both
        radiologic imaging and during surgical resection. Therefore, radioactive seed-guided
        resection of these tumors, analogously to breast cancer, could be an interesting approach.
        The investigators present two cases of cirrhotic patients where this method of tumor
        labelling was used.
  The investigators selected two cases of patients with liver cirrhosis where seed-guided liver
        resection was used. Seed-guided resection is procedure that is usually commonly used in
        breast cancer surgery but so far not in liver surgery.
  
        This report emphasizes the difficulties, which surgeons and radiologists may face in tumor
        entities that are difficult to identify both macroscopically, by palpation and intraoperative
        imaging techniques.
  
        The first case was a patient suffering from suspected hepatocellular carcinoma with the
        background of alcoholic liver cirrhosis. This patient already underwent liver surgery to
        remove the suspected tumour but the lesion could not be removed correctly as identification
        was not possible neither with palpation nor with the help of intraoperative ultrasound. For
        this reason, the patient was selected for seed-guided resection.
  
        The second patient, who presented nine months after the first one, presented with the
        suspicion of cirrhosis, two lesion small in size and in a surgically difficult localization.
        Therefore, the patient was selected for seed-guided resection.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: R0-Resection according to the tumour classification system
  time frame: 1 week after operation
  description: Removal of the tumour in healthy tissue, which means that microscopically no tumour tissue is detectable in the resection margin of the removed tissue.
  This is always examined by a trained pathologist.
  measure: Procedure-Safety (No residual source of radiation)
  time frame: 1 Day
  description: Complete seed extraction was confirmed intraoperatively by specimen radiography immediately after tissue removal and by ensuring that no residual source of radiation is traceable in the patient with the gamma probe system.
  measure: Number of patients without side effects
  time frame: 6 months
  description: Clinical follow up of the patients to ensure that there are no side effects from implanting the Seed in the liver
  arm group label: Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients
  arm group type: Other
  description: Detection of cholangiocellular and hepatocellular carcinomas can be challenging in both radiologic imaging and during surgical resection. Therefore, radioactive seed-guided resection of these tumors, analogously to breast cancer, could be an interesting approach.
  This report emphasizes the difficulties, which surgeons and radiologists may face in tumor entities that are difficult to identify both macroscopically, by palpation and intraoperative imaging techniques. It also highlights the successful adaption of a procedure commonly used for breast cancer surgery for liver surgery
  intervention type: Device
  intervention name: Radioactive Seed Implantation
  description: In patients where initially the tumour lesion could not be identified, a radioactive seed was implanted and intraoperatively detected with a geiger counter sonde.
  arm group label: Radioactive seed-guided resection of cholangiocellular carcinoma in cirrhotic patients
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Savas D Soysal, Professor
  role: Principal Investigator
  affiliation: Clarunis Basel
  facility: 
  country: Switzerland
  responsible party type: Principal Investigator
  investigator affiliation: Clarunis - Universitäres Bauchzentrum Basel
  investigator full name: Savas Soysal
  investigator title: Principal Investigator
  mesh term: Cholangiocarcinoma
  mesh term: Liver Cirrhosis