<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/NCT01713244</url>
  </required_header>
  <id_info>
    <org_study_id>SKLKF201209</org_study_id>
    <nct_id>NCT01713244</nct_id>
  </id_info>
  <brief_title>Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma</brief_title>
  <official_title>A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southwest Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use,&#xD;
      safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small&#xD;
      vessels while destroyed the tumor cell in situ. Surgical resection is the most widely&#xD;
      accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian&#xD;
      countries. But the effectiveness of hepatectomy was depressed because of the high recurrence&#xD;
      rate. The spreading of the cancer cell along the portal vein or the hepatic vein system&#xD;
      during the operation account for the tumor recurrence. Using RFA to ablate and block the&#xD;
      small vessels around the tumor before resection will reduce the spreading of the cancer cell.&#xD;
      Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence&#xD;
      rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study&#xD;
      was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone&#xD;
      for the treatment of advanced HCC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</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>Recurrence-free Survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Hepatectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using Hepatectomy for the treatment of advanced HCC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RFA assisted Hepatectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ablating the liver tissue around the tumor before hepatectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RFA assisted Hepatectomy</intervention_name>
    <description>Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.</description>
    <arm_group_label>RFA assisted Hepatectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hepatectomy</intervention_name>
    <description>Treat the advanced HCC with the hepatectomy only.</description>
    <arm_group_label>Hepatectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of HCC confirmed at our hospital.&#xD;
&#xD;
          2. Intrahepatic tumor count no higher than 3 and a minimum tumor diameter &gt; 3 cm, but no&#xD;
             more than 8cm.&#xD;
&#xD;
          3. Liver function of Child-Pugh Class A or B.&#xD;
&#xD;
          4. Tumors lacked intrahepatic and extrahepatic metastasis.&#xD;
&#xD;
          5. Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary&#xD;
             branches.&#xD;
&#xD;
          6. Indocyanine green retention at 15 minutes (ICG-15) of &lt;10%.&#xD;
&#xD;
          7. No evidence of coagulopathy: platelet count &gt; 50 × 109/L and a prolonged prothrombin&#xD;
             time of &lt; 5 seconds.&#xD;
&#xD;
          8. No other anti-tumor therapy received before the treatment. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients met the inclusion criteria but declined to participate.&#xD;
&#xD;
          2. Patients with severe portal hypertension, a history of esophageal variceal hemorrhage,&#xD;
             severe hypersplenism syndrome, or refractory ascites.&#xD;
&#xD;
          3. Patients whose permanent pathology after treatment suggested metastatic liver cancer&#xD;
             or primary liver cancer of another tissue type.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuansheng Ma, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Institute of hepatobiliary surgery,Southwest Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kai Feng, M.D</last_name>
    <phone>+86-23-13228683383</phone>
    <email>fengkai7688@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of hepatobiliary surgery,Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kai Feng, M.D</last_name>
      <phone>+86-23-13228683383</phone>
      <email>fengkai7688@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Kai Feng, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>November 19, 2015</last_update_submitted>
  <last_update_submitted_qc>November 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southwest Hospital, China</investigator_affiliation>
    <investigator_full_name>fengkai</investigator_full_name>
    <investigator_title>Institute of Hepatobiliary Surgery</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Radiofrequency Ablation</keyword>
  <keyword>Hepatectomy</keyword>
  <keyword>Recurrence</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>
  </condition_browse>
  <!-- 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/NCT01713244
org study id: SKLKF201209
nct id: NCT01713244
lead sponsor: 
has dmc: Yes
RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use,
      safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small
      vessels while destroyed the tumor cell in situ. Surgical resection is the most widely
      accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian
      countries. But the effectiveness of hepatectomy was depressed because of the high recurrence
      rate. The spreading of the cancer cell along the portal vein or the hepatic vein system
      during the operation account for the tumor recurrence. Using RFA to ablate and block the
      small vessels around the tumor before resection will reduce the spreading of the cancer cell.
      Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence
      rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study
      was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone
      for the treatment of advanced HCC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence-free Survival
time frame: 2 years
measure: Overall Survival
time frame: 2 years
measure: Number of participants with adverse events
time frame: 2 years
arm group label: Hepatectomy
arm group type: Active Comparator
description: Using Hepatectomy for the treatment of advanced HCC
arm group label: RFA assisted Hepatectomy
arm group type: Experimental
description: Ablating the liver tissue around the tumor before hepatectomy.
intervention type: Procedure
intervention name: RFA assisted Hepatectomy
description: Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.
arm group label: RFA assisted Hepatectomy
intervention type: Procedure
intervention name: Hepatectomy
description: Treat the advanced HCC with the hepatectomy only.
arm group label: Hepatectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kuansheng Ma, Ph.D
role: Study Director
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
last name: Kai Feng, M.D
phone: +86-23-13228683383
email: fengkai7688@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southwest Hospital, China
investigator full name: fengkai
investigator title: Institute of Hepatobiliary Surgery
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular