<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/NCT04413526</url>
  </required_header>
  <id_info>
    <org_study_id>radiofrequency liver resection</org_study_id>
    <nct_id>NCT04413526</nct_id>
  </id_info>
  <brief_title>Radiofrequency-assisted Liver Resection in Intractable Liver Cancer</brief_title>
  <official_title>The Application of Radiofrequency-assisted Liver Resection in Intractable Liver Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hepatopancreatobiliary Surgery Institute of Gansu Province</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hepatopancreatobiliary Surgery Institute of Gansu Province</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>
      In this retrospective study, the investigators assessed the application of&#xD;
      radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to&#xD;
      analysis the different factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary clinical treatment of liver cancer is surgical resection, although many&#xD;
      integrated applications develop rapidly, surgery is still the best way to remove the tumour&#xD;
      lesion. Traditional ways that have curative removed tumours in three methods, which are liver&#xD;
      resection, liver transplantation and radiofrequency ablation (RFA).&#xD;
&#xD;
      As for primary liver cancer, surgery, and RFA are both effective and safety, but for the&#xD;
      complexity of end-stage liver cancer, surgical resection may not remove the tumours alone.&#xD;
      Surgical resection with radiofrequency ablation therapy for intractable liver cancer is a&#xD;
      kind of active plan. The therapy can eliminate the tumour, maximize the protection of patient&#xD;
      liver tissue, reduce operation damage, reduce the incidence of complications, and improve&#xD;
      patients quality of life after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">November 18, 2021</completion_date>
  <primary_completion_date type="Actual">November 18, 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>The survival rates for one-year to five-year</measure>
    <time_frame>5 years</time_frame>
    <description>The survival rates was defined as the percentage of liver cancer for five years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The hospital stay</measure>
    <time_frame>3 months</time_frame>
    <description>The length of stay in a hospital regarding days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Child-Pugh score after therapy</measure>
    <time_frame>3 months</time_frame>
    <description>The Child-Pugh is based on the presence and severity of ascites and hepatic encephalopathy, the prolongation of prothrombin time, and the levels of serum bilirubin and albumin. According to the Child-Pugh scores, patients are classified into three classes (Child class A, B, and C with CP scores 5-6, 7-9, and 10-15, respectively)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">199</enrollment>
  <condition>Liver Cancer</condition>
  <arm_group>
    <arm_group_label>radiofrequency-assisted liver resection</arm_group_label>
    <description>radiofrequency-assisted liver resection for intractable liver cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TACE(transcatheter arterial chemoembolization)</arm_group_label>
    <description>temporary TACE for intractable liver cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>radiofrequency ablation plus TACE</arm_group_label>
    <description>radiofrequency ablation plus TACE for intractable liver cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radiofrequency</intervention_name>
    <description>radiofrequency combined with liver resection</description>
    <arm_group_label>radiofrequency-assisted liver resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TACE</intervention_name>
    <description>only TACE treatment</description>
    <arm_group_label>TACE(transcatheter arterial chemoembolization)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TACE+radiofrequency</intervention_name>
    <description>TACE followed by radiofrequency</description>
    <arm_group_label>radiofrequency ablation plus TACE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HCC patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ultrasound-guided fine-needle aspiration pathology or postoperative pathology was&#xD;
             confirmed to be liver cancer, no pathological results according to China 's 2017&#xD;
             version of the hepatocarcinoma (HCC) diagnosis and treatment specifications, in line&#xD;
             with the standard clinical diagnosis of liver cancer&#xD;
&#xD;
          -  According to Barcelona Clinic Liver Cancer (BCLC) staging criteria, it is stage C&#xD;
             (stage C: single tumour&gt; 5 cm or more than three tumours, and at least one tumour&gt; 3&#xD;
             cm, liver function Child-Pugh A or B, with lymph node metastasis or distant metastasis&#xD;
             or portal vein or Venous liver trunk is invaded, penance Status (PST) score 1-2&#xD;
             points)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HCC patients with other malignant tumours&#xD;
&#xD;
          -  Metastatic liver tumour&#xD;
&#xD;
          -  Patients with liver abscess&#xD;
&#xD;
          -  Patients with organ dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenbo Meng, M.D., Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hepatopancreatobiliary Surgery Institute of Gansu Province</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hepatopancreatobiliary Surgery Institute of Gansu Province</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sun Y, Ji S, Ji H, Liu L, Li C. Clinical efficacy analysis of transcatheter arterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) in primary liver cancer and recurrent liver cancer. J BUON. 2019 Jul-Aug;24(4):1402-1407.</citation>
    <PMID>31646783</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hepatopancreatobiliary Surgery Institute of Gansu Province</investigator_affiliation>
    <investigator_full_name>Wenbo Meng</investigator_full_name>
    <investigator_title>head of surgery</investigator_title>
  </responsible_party>
  <keyword>RFA</keyword>
  <keyword>liver cancer</keyword>
  <keyword>surgical resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorotrianisene</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04413526
org study id: radiofrequency liver resection
nct id: NCT04413526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this retrospective study, the investigators assessed the application of
      radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to
      analysis the different factors.
The primary clinical treatment of liver cancer is surgical resection, although many
      integrated applications develop rapidly, surgery is still the best way to remove the tumour
      lesion. Traditional ways that have curative removed tumours in three methods, which are liver
      resection, liver transplantation and radiofrequency ablation (RFA).

      As for primary liver cancer, surgery, and RFA are both effective and safety, but for the
      complexity of end-stage liver cancer, surgical resection may not remove the tumours alone.
      Surgical resection with radiofrequency ablation therapy for intractable liver cancer is a
      kind of active plan. The therapy can eliminate the tumour, maximize the protection of patient
      liver tissue, reduce operation damage, reduce the incidence of complications, and improve
      patients quality of life after surgery.
observational model: Cohort
time perspective: Retrospective
measure: The survival rates for one-year to five-year
time frame: 5 years
description: The survival rates was defined as the percentage of liver cancer for five years.
measure: The hospital stay
time frame: 3 months
description: The length of stay in a hospital regarding days
measure: The Child-Pugh score after therapy
time frame: 3 months
description: The Child-Pugh is based on the presence and severity of ascites and hepatic encephalopathy, the prolongation of prothrombin time, and the levels of serum bilirubin and albumin. According to the Child-Pugh scores, patients are classified into three classes (Child class A, B, and C with CP scores 5-6, 7-9, and 10-15, respectively)
arm group label: radiofrequency-assisted liver resection
description: radiofrequency-assisted liver resection for intractable liver cancer
arm group label: TACE(transcatheter arterial chemoembolization)
description: temporary TACE for intractable liver cancer
arm group label: radiofrequency ablation plus TACE
description: radiofrequency ablation plus TACE for intractable liver cancer
intervention type: Procedure
intervention name: radiofrequency
description: radiofrequency combined with liver resection
arm group label: radiofrequency-assisted liver resection
intervention type: Procedure
intervention name: TACE
description: only TACE treatment
arm group label: TACE(transcatheter arterial chemoembolization)
intervention type: Procedure
intervention name: TACE+radiofrequency
description: TACE followed by radiofrequency
arm group label: radiofrequency ablation plus TACE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Wenbo Meng, M.D., Ph. D.
role: Principal Investigator
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
facility: 
country: China
citation: Sun Y, Ji S, Ji H, Liu L, Li C. Clinical efficacy analysis of transcatheter arterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) in primary liver cancer and recurrent liver cancer. J BUON. 2019 Jul-Aug;24(4):1402-1407.
PMID: 31646783
responsible party type: Principal Investigator
investigator affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
investigator full name: Wenbo Meng
investigator title: head of surgery
mesh term: Liver Neoplasms
mesh term: Chlorotrianisene
sharing ipd: No