<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/NCT04422249</url>
  </required_header>
  <id_info>
    <org_study_id>SWHZSG009</org_study_id>
    <nct_id>NCT04422249</nct_id>
  </id_info>
  <brief_title>A Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy</brief_title>
  <official_title>A RCT Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study, entitled &quot;RCT study of laparoscopic middle hepatic venous guidance versus&#xD;
      conventional ananatomical hemihepatectomy&quot;, was designed to compare the efficacy of two&#xD;
      different ananatomical hemihepatectomy procedures under laparoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Backgroud &amp; Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases,&#xD;
      which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them,&#xD;
      anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign&#xD;
      and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous&#xD;
      guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to&#xD;
      observe and compare the perioperative period and follow-up results of the two different&#xD;
      laparoscopic surgical resection methods, and to provide high-level evidence-based medicine&#xD;
      evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 23, 2019</start_date>
  <completion_date type="Anticipated">December 23, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 23, 2022</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>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Two different treatments are conducted on the participant base on the randomized choices</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate</measure>
    <time_frame>3 years</time_frame>
    <description>follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perioperative results</measure>
    <time_frame>Duration perioperation(an expected average of 3 days)</time_frame>
    <description>the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative parameters</measure>
    <time_frame>during the operation</time_frame>
    <description>blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡）</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of postoperative complications</measure>
    <time_frame>Duration hospitalization(an expected average of 7 days)</time_frame>
    <description>hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiopulmonary insufficiency，liver function failure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">95</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>laparoscopic middle hepatic vein guidance hemihepatectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In theory, the advantages of anatomical hemihepatectomy guided by middle hepatic vein are as follows: 1) correctly guiding the transecting plane of the liver parenchyma can reduce the cross-sectional area of the liver and avoid damaging the vascular ducts of the pre-cut liver. so as to reduce the residue of necrotic tissue without blood supply and reduce the occurrence of postoperative complications. 2) active anatomy and exposure of hepatic vein can avoid uncontrollable bleeding after passive injury of hepatic vein, and laparoscopic anatomy has obvious advantage in exposing hepatic vein. 3) it may reduce the early recurrence rate of hepatocellular carcinoma after operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laparoscopic traditional anatomic hemihepatectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to textbooks and the views of some scholars at present, traditional anatomical hepatectomy (non-hepatic vein-guided anatomical hepatectomy) has the following advantages: 1) avoiding exposure of hepatic vein can reduce the probability of injury to the trunk of hepatic vein, thus reduce the risk of massive bleeding during operation; 2) the difficulty of operation is relatively low, and a better short-term and long-term effect can be obtained.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic middle hepatic vein guidance anatomic hemihepatectomy</intervention_name>
    <description>95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period</description>
    <arm_group_label>laparoscopic middle hepatic vein guidance hemihepatectomy</arm_group_label>
    <arm_group_label>laparoscopic traditional anatomic hemihepatectomy</arm_group_label>
    <other_name>laparoscopic traditional anatomic hemihepatectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. the site was limited to the patients who were suitable for dissecting hemihepatectomy；&#xD;
&#xD;
          2. the type of disease was limited to hepatocellular carcinoma；&#xD;
&#xD;
          3. the patients were generally able to tolerate anesthesia, the liver reserve function&#xD;
             was good, and the patients were suitable for laparoscopic surgery；&#xD;
&#xD;
          4. child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic&#xD;
             and extrahepatic metastasis and main vascular invasion；&#xD;
&#xD;
          5. the subjects who participated in this study indicated that they were willing to accept&#xD;
             the two surgical methods and agreed to be randomly divided into groups during the&#xD;
             operation；&#xD;
&#xD;
          6. 18 ≤ age ≤ 70, male or female.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. preoperative liver function Child-pugh grade B or C;&#xD;
&#xD;
          2. patients with poor general condition and could not tolerate pneumoperitoneum or&#xD;
             anesthesia;&#xD;
&#xD;
          3. patients with severe liver cirrhosis, portal hypertension and lesions invading liver&#xD;
             porta;&#xD;
&#xD;
          4. patients with other treatment methods such as radio frequency ablation in addition to&#xD;
             dissecting hepatectomy;&#xD;
&#xD;
          5. repeated abdominal operations resulting in severe abdominal adhesion, unable to&#xD;
             perform laparoscopic hepatectomy; male and female are not limited&#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_contact>
    <last_name>Shuguo Zheng, M.D.</last_name>
    <phone>0086-13508308676</phone>
    <email>shuguozh@yahoo.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shuguo Zheng, Zheng</last_name>
    <phone>0086-13508308676</phone>
    <email>shuguozh@yahoo.com.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuguo Zheng, MD</last_name>
      <phone>0086-13508308676</phone>
      <email>shuguozh@yahoo.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southwest Hospital, China</investigator_affiliation>
    <investigator_full_name>Shuguo Zheng, MD</investigator_full_name>
    <investigator_title>Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic Middle hepatic vein Hepatocellular carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04422249
org study id: SWHZSG009
nct id: NCT04422249
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus
      conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two
      different ananatomical hemihepatectomy procedures under laparoscopy.
Backgroud & Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases,
      which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them,
      anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign
      and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous
      guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to
      observe and compare the perioperative period and follow-up results of the two different
      laparoscopic surgical resection methods, and to provide high-level evidence-based medicine
      evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Two different treatments are conducted on the participant base on the randomized choices
measure: Survival rate
time frame: 3 years
description: follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival
measure: Perioperative results
time frame: Duration perioperation(an expected average of 3 days)
description: the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC
measure: intraoperative parameters
time frame: during the operation
description: blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡）
measure: Incidence of postoperative complications
time frame: Duration hospitalization(an expected average of 7 days)
description: hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiopulmonary insufficiency，liver function failure
arm group label: laparoscopic middle hepatic vein guidance hemihepatectomy
arm group type: Experimental
description: In theory, the advantages of anatomical hemihepatectomy guided by middle hepatic vein are as follows: 1) correctly guiding the transecting plane of the liver parenchyma can reduce the cross-sectional area of the liver and avoid damaging the vascular ducts of the pre-cut liver. so as to reduce the residue of necrotic tissue without blood supply and reduce the occurrence of postoperative complications. 2) active anatomy and exposure of hepatic vein can avoid uncontrollable bleeding after passive injury of hepatic vein, and laparoscopic anatomy has obvious advantage in exposing hepatic vein. 3) it may reduce the early recurrence rate of hepatocellular carcinoma after operation.
arm group label: laparoscopic traditional anatomic hemihepatectomy
arm group type: Active Comparator
description: According to textbooks and the views of some scholars at present, traditional anatomical hepatectomy (non-hepatic vein-guided anatomical hepatectomy) has the following advantages: 1) avoiding exposure of hepatic vein can reduce the probability of injury to the trunk of hepatic vein, thus reduce the risk of massive bleeding during operation; 2) the difficulty of operation is relatively low, and a better short-term and long-term effect can be obtained.
intervention type: Procedure
intervention name: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy
description: 95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period
arm group label: laparoscopic middle hepatic vein guidance hemihepatectomy
arm group label: laparoscopic traditional anatomic hemihepatectomy
other name: laparoscopic traditional anatomic hemihepatectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shuguo Zheng, M.D.
phone: 0086-13508308676
email: shuguozh@yahoo.com.cn
last name: Shuguo Zheng, Zheng
phone: 0086-13508308676
email: shuguozh@yahoo.com.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southwest Hospital, China
investigator full name: Shuguo Zheng, MD
investigator title: Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department
mesh term: Carcinoma, Hepatocellular