<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/NCT03766555</url>
  </required_header>
  <id_info>
    <org_study_id>2016.205</org_study_id>
    <nct_id>NCT03766555</nct_id>
  </id_info>
  <brief_title>Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function</brief_title>
  <official_title>Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      We propose a randomized controlled study to compare the treatment efficacy of microwave&#xD;
      ablation to liver resection for hepatocellular carcinoma (HCC) in patients with borderline&#xD;
      liver function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatocellular carcinoma (HCC) is a common cancer and is diagnosed at an earlier stage and&#xD;
      with increasing frequency because of the wider implementation of screening programs. Whether&#xD;
      liver resection or local ablation should be the first-line treatment in early HCC remains a&#xD;
      hot topic for debate. Both are regarded as acceptable curative treatment for early HCC in&#xD;
      many international guidelines. Underlying liver function is the key in treatment selection.&#xD;
      The general consensus is that liver resection should be the treatment of choice in patients&#xD;
      with good liver function while local ablation should be considered in patients with poor&#xD;
      liver function. There exists a group of patients with apparently good liver function that&#xD;
      harbor significant liver cirrhosis which is not easily picked up by the current assessment or&#xD;
      scoring systems. Liver resection in this group of patients is burdened by potentially&#xD;
      life-threatening complications and the overall survival is limited by their underlying liver&#xD;
      cirrhosis. This is particularly important in early HCC as local ablation is another curative&#xD;
      treatment option. In order to improve the prognosis of patients with early HCC, it is&#xD;
      important to identify (1) patients with liver dysfunction to the extend that the risk of&#xD;
      liver resection will outweigh the survival benefit it provides; (2) the best ablative method&#xD;
      for HCC.&#xD;
&#xD;
      The investigators propose to carry out a prospective randomized controlled study to compare&#xD;
      the treatment outcome of microwave ablation with liver resection in patients with borderline&#xD;
      liver function whose HCC that are amendable to both liver resection and microwave ablation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 21, 2018</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>
    <intervention_model_description>This is a prospective randomized study to be conducted in an academic hospital with a specialized hepato-biliary team. The principal investigator and other members within the team will perform patient selection and recruitment of this study according to the inclusion and exclusion criteria.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>The primary outcome of this study is the overall survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Disease-free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>5 years</time_frame>
    <description>Liver cancer recurrence rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity rate</measure>
    <time_frame>1 year</time_frame>
    <description>Morbidity rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>1 year</time_frame>
    <description>Hospital length of stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>Microwave Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Microwave ablation (MWA) will be performed in patients randomized to this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liver Resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liver resection will be performed in patients randomized to this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microwave ablation</intervention_name>
    <description>Microwave ablation will be performed in operation theatre under general anesthesia via laparoscopic or open approach according to the tumors' locations. In case of open approach, it will be done via a right subcostal incision with possible upper midline extension was necessary. After diagnostic laparoscopy in laparoscopic approach and exploratory laparotomy in open approach to exclude the presence of extra-hepatic disease, operative ultrasound (Aloka, Tokyo, Japan) will be performed to exclude preoperatively undetected lesion; guide insertion of the microwave applicator; and monitor the whole ablation process. Surrounding organs were cooled by constant irrigation of ice-cold saline to prevent thermal injury. The ablation will be carried out according to the standard protocol with the aim to create a 1cm ablation margin around the tumor. The insertion track will be burnt after ablation in order to prevent bleeding and tumor seeding.</description>
    <arm_group_label>Microwave Ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver resection</intervention_name>
    <description>Liver resection will be performed as described previously. Liver parenchymal transection would be performed with CUSA (cavitron ultrasonic surgical aspirator) and TissueLink (a radiofrequency saline-linked dissecting sealer) in both arms. Vascular staplers would be used to divide major vascular pedicles. Fibrin glue (Tisseel) spray would be applied to the parenchymal cut surface of the liver before closure of abdomen.</description>
    <arm_group_label>Liver Resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  HCC amendable for both MWA and liver resection&#xD;
&#xD;
          -  Liver function of ALBI Grade 2&#xD;
&#xD;
          -  Tumour size &lt;/= 5cm&#xD;
&#xD;
          -  Absence of extrahepatic metastasis&#xD;
&#xD;
          -  Absence of radiology evidence of major vascular or bile duct invasion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Informed consent not available&#xD;
&#xD;
          -  Patients with ALBI 3, Child-Pugh B or above&#xD;
&#xD;
          -  Multifocal tumour&#xD;
&#xD;
          -  Presence of portal vein or hepatic artery thrombosis&#xD;
&#xD;
          -  Anticipation of concomitant procedures&#xD;
&#xD;
          -  Emergency hepatectomy&#xD;
&#xD;
          -  Ruptured HCC&#xD;
&#xD;
          -  Patients with chronic renal failure&#xD;
&#xD;
          -  Pregnant female patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charing CN Chong, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chun Yeung, MSc</last_name>
    <phone>35053933</phone>
    <email>philipyeung@surgery.cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charing CN Chong, MBChB</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <link>
    <url>http://www3.ha.org.hk/cancereg/pdf/overview/Summary%20of%20CanStat%202012.pdf</url>
    <description>Hong Kong Hospital Authority. Hong Kong Cancer Registry. 2012.</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Charing Chong, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>Hepatectomy</keyword>
  <keyword>Microwave Ablation</keyword>
  <keyword>Local Ablation</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/NCT03766555
org study id: 2016.205
nct id: NCT03766555
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We propose a randomized controlled study to compare the treatment efficacy of microwave
      ablation to liver resection for hepatocellular carcinoma (HCC) in patients with borderline
      liver function.
Hepatocellular carcinoma (HCC) is a common cancer and is diagnosed at an earlier stage and
      with increasing frequency because of the wider implementation of screening programs. Whether
      liver resection or local ablation should be the first-line treatment in early HCC remains a
      hot topic for debate. Both are regarded as acceptable curative treatment for early HCC in
      many international guidelines. Underlying liver function is the key in treatment selection.
      The general consensus is that liver resection should be the treatment of choice in patients
      with good liver function while local ablation should be considered in patients with poor
      liver function. There exists a group of patients with apparently good liver function that
      harbor significant liver cirrhosis which is not easily picked up by the current assessment or
      scoring systems. Liver resection in this group of patients is burdened by potentially
      life-threatening complications and the overall survival is limited by their underlying liver
      cirrhosis. This is particularly important in early HCC as local ablation is another curative
      treatment option. In order to improve the prognosis of patients with early HCC, it is
      important to identify (1) patients with liver dysfunction to the extend that the risk of
      liver resection will outweigh the survival benefit it provides; (2) the best ablative method
      for HCC.

      The investigators propose to carry out a prospective randomized controlled study to compare
      the treatment outcome of microwave ablation with liver resection in patients with borderline
      liver function whose HCC that are amendable to both liver resection and microwave ablation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a prospective randomized study to be conducted in an academic hospital with a specialized hepato-biliary team. The principal investigator and other members within the team will perform patient selection and recruitment of this study according to the inclusion and exclusion criteria.
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 5 years
description: The primary outcome of this study is the overall survival
measure: Disease-free survival
time frame: 5 years
description: Disease-free survival
measure: Recurrence rate
time frame: 5 years
description: Liver cancer recurrence rate
measure: Morbidity rate
time frame: 1 year
description: Morbidity rate
measure: Hospital stay
time frame: 1 year
description: Hospital length of stay
arm group label: Microwave Ablation
arm group type: Experimental
description: Microwave ablation (MWA) will be performed in patients randomized to this arm.
arm group label: Liver Resection
arm group type: Active Comparator
description: Liver resection will be performed in patients randomized to this arm.
intervention type: Procedure
intervention name: Microwave ablation
description: Microwave ablation will be performed in operation theatre under general anesthesia via laparoscopic or open approach according to the tumors' locations. In case of open approach, it will be done via a right subcostal incision with possible upper midline extension was necessary. After diagnostic laparoscopy in laparoscopic approach and exploratory laparotomy in open approach to exclude the presence of extra-hepatic disease, operative ultrasound (Aloka, Tokyo, Japan) will be performed to exclude preoperatively undetected lesion; guide insertion of the microwave applicator; and monitor the whole ablation process. Surrounding organs were cooled by constant irrigation of ice-cold saline to prevent thermal injury. The ablation will be carried out according to the standard protocol with the aim to create a 1cm ablation margin around the tumor. The insertion track will be burnt after ablation in order to prevent bleeding and tumor seeding.
arm group label: Microwave Ablation
intervention type: Procedure
intervention name: Liver resection
description: Liver resection will be performed as described previously. Liver parenchymal transection would be performed with CUSA (cavitron ultrasonic surgical aspirator) and TissueLink (a radiofrequency saline-linked dissecting sealer) in both arms. Vascular staplers would be used to divide major vascular pedicles. Fibrin glue (Tisseel) spray would be applied to the parenchymal cut surface of the liver before closure of abdomen.
arm group label: Liver Resection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charing CN Chong, MBChB
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Chun Yeung, MSc
phone: 35053933
email: philipyeung@surgery.cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
url: http://www3.ha.org.hk/cancereg/pdf/overview/Summary%20of%20CanStat%202012.pdf
description: Hong Kong Hospital Authority. Hong Kong Cancer Registry. 2012.
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Charing Chong, MD
investigator title: Assistant Professor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular