<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/NCT04499261</url>
  </required_header>
  <id_info>
    <org_study_id>SWHZSG010</org_study_id>
    <nct_id>NCT04499261</nct_id>
  </id_info>
  <brief_title>Laparoscopic Versus Open Surgery for Lesions Originating in the Paracaval Portion of the Caudate Lobe</brief_title>
  <official_title>A Prospective Cohort Study: Laparoscopic Versus Open Surgery for Lesions Originating in the Paracaval Portion of the Caudate Lobe</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>
      This study aimed to evaluate the safety, feasibility and efficacy of laparoscopic for&#xD;
      resecting paracaval-originating lesions by contrast of open procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The paracaval portion of the caudate lobe is located in the core of the liver. Lesions&#xD;
      originating in the paracaval portion often cling to or even invade major hepatic vascular&#xD;
      structures. Open surgery is the traditional surgical method for resection of&#xD;
      paracaval-originating lesions. With the development of laparoscopic surgery,&#xD;
      paracaval-originating lesions are no longer an absolute contraindication for laparoscopic&#xD;
      procedures. The high-definition magnified view and ability to change perspectives with the&#xD;
      laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide&#xD;
      pneumoperitoneum can reduce venous bleeding. Nevertheless, laparoscopic anterior hepatic&#xD;
      transection for paracaval-originating lesion resection is still a challenging procedure, and&#xD;
      only a few cases have been reported. This study aimed to evaluate the safety, feasibility and&#xD;
      efficacy of laparoscopic for resecting paracaval-originating lesions by contrast of open&#xD;
      procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 25, 2019</start_date>
  <completion_date type="Anticipated">September 25, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>survival rate</measure>
    <time_frame>3 years</time_frame>
    <description>follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates，disease-free survival rates , recurrence and metastasis rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operation time</measure>
    <time_frame>during the operation</time_frame>
    <description>intraoperative parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative blood loss</measure>
    <time_frame>during the operation</time_frame>
    <description>intraoperative parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of blood transfusion.</measure>
    <time_frame>during the operation</time_frame>
    <description>intraoperative parameter</description>
  </secondary_outcome>
  <other_outcome>
    <measure>postoperative complications</measure>
    <time_frame>Duration hospitalization(an expected average of 7 days)</time_frame>
    <description>ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Paracaval Portion</condition>
  <arm_group>
    <arm_group_label>laparoscopic surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The laparoscopic view is caudal to cephalic, which is consistent with the direction of hepatic transection. In addition, the high-definition magnified view and ability to change perspectives with the laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide pneumoperitoneum can reduce venous bleeding. Therefore, laparoscopic surgery may have certain advantages in the treatment of paracaval-originating lesions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open surgery is the traditional surgical method for resection of paracaval-originating lesions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic surgery</intervention_name>
    <description>Patients were supine in a reverse Trendelenburg position and received intravenous inhalation combined with anesthesia. The patients' legs were spread apart. A carbon dioxide pneumoperitoneum was established. The intermittent Pringle's maneuver was carried out when necessary. Five trocars were placed in a fan shape around the lesion. Cholecystectomy was performed routinely. First, the liver was mobilized. Then, the liver parenchyma was transected and the branches of the hepatic veins and pedicles encountered were clipped and divided. The lesion was meticulously separated from the vascular structures and liver parenchyma and completely resected. The raw surface was treated with bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed. Finally, the specimens were packed in a specimen bag and removed. The raw surface was packed with biological hemostatic materials, and drainage tubes were routinely placed.</description>
    <arm_group_label>laparoscopic surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open surgery</intervention_name>
    <description>Patients were placed in the supine position and received intravenous inhalation combined with anesthesia. The intermittent Pringle's maneuver was carried out when necessary. Routinely, a reversed L-shape incision was performed. Cholecystectomy was performed routinely. First, the liver was mobilized. Then, the liver parenchyma was transected and the branches of the hepatic veins and pedicles encountered were clipped and divided. The lesion was meticulously separated from the vascular structures and liver parenchyma and completely resected. The raw surface was treated with bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed. Finally, the specimens were packed in a specimen bag and removed. The raw surface was packed with biological hemostatic materials, and drainage tubes were routinely placed.</description>
    <arm_group_label>Open surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: Between 18 to 70 years, both male and female&#xD;
&#xD;
          2. The general condition of the patient can tolerate anesthesia and surgery&#xD;
&#xD;
          3. Paracaval-originating lesion diagnosis is clear preoperative&#xD;
&#xD;
          4. No rupture of the tumor, no bloody ascites, no invasion of the surrounding tissues and&#xD;
             distant metastasis&#xD;
&#xD;
          5. Liver function ≥ Child-pugh level B, indocyanine green retention rate at 15 min ≤ 15%,&#xD;
             the residual liver volume and standard liver volume ratio ≥ 40%.&#xD;
&#xD;
          6. Upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy&#xD;
             And Embolization treatment, radiotherapy and chemotherapy have not been implemented&#xD;
&#xD;
          7. Volunteer to participate in the study and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Age:Younger than 18 or more than 70 years old 2. Pregnant and lactating women 3. Severe&#xD;
        cirrhosis, portal hypertension, or active hepatitis are present 4. Severe upper abdominal&#xD;
        adhesions 5. The lesion originated in other parts of the liver other than the paracaval&#xD;
        portion 6. Patients with poor general condition and could not tolerate surgery or&#xD;
        anesthesia&#xD;
&#xD;
        -&#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>Shuguo Zheng, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery, Southwest Hospital, Army medical university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shuguo Zheng, M.D.</last_name>
    <phone>0086-13508308676</phone>
    <email>shuguozh@yahoo.com.cn</email>
  </overall_contact>
  <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, M.D.</last_name>
      <phone>0086-13508308676</phone>
      <email>shuguozh@yahoo.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</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>Laparoscopy</keyword>
  <keyword>hepatectomy</keyword>
  <keyword>Caudate Lobe</keyword>
  <!-- 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/NCT04499261
org study id: SWHZSG010
nct id: NCT04499261
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to evaluate the safety, feasibility and efficacy of laparoscopic for
      resecting paracaval-originating lesions by contrast of open procedures.
The paracaval portion of the caudate lobe is located in the core of the liver. Lesions
      originating in the paracaval portion often cling to or even invade major hepatic vascular
      structures. Open surgery is the traditional surgical method for resection of
      paracaval-originating lesions. With the development of laparoscopic surgery,
      paracaval-originating lesions are no longer an absolute contraindication for laparoscopic
      procedures. The high-definition magnified view and ability to change perspectives with the
      laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide
      pneumoperitoneum can reduce venous bleeding. Nevertheless, laparoscopic anterior hepatic
      transection for paracaval-originating lesion resection is still a challenging procedure, and
      only a few cases have been reported. This study aimed to evaluate the safety, feasibility and
      efficacy of laparoscopic for resecting paracaval-originating lesions by contrast of open
      procedures.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: survival rate
time frame: 3 years
description: follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates，disease-free survival rates , recurrence and metastasis rate.
measure: operation time
time frame: during the operation
description: intraoperative parameter
measure: intraoperative blood loss
time frame: during the operation
description: intraoperative parameter
measure: rate of blood transfusion.
time frame: during the operation
description: intraoperative parameter
measure: postoperative complications
time frame: Duration hospitalization(an expected average of 7 days)
description: ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.
arm group label: laparoscopic surgery
arm group type: Experimental
description: The laparoscopic view is caudal to cephalic, which is consistent with the direction of hepatic transection. In addition, the high-definition magnified view and ability to change perspectives with the laparoscope are conducive to subtle manipulation, and compression of the carbon dioxide pneumoperitoneum can reduce venous bleeding. Therefore, laparoscopic surgery may have certain advantages in the treatment of paracaval-originating lesions.
arm group label: Open surgery
arm group type: Active Comparator
description: Open surgery is the traditional surgical method for resection of paracaval-originating lesions.
intervention type: Procedure
intervention name: laparoscopic surgery
description: Patients were supine in a reverse Trendelenburg position and received intravenous inhalation combined with anesthesia. The patients' legs were spread apart. A carbon dioxide pneumoperitoneum was established. The intermittent Pringle's maneuver was carried out when necessary. Five trocars were placed in a fan shape around the lesion. Cholecystectomy was performed routinely. First, the liver was mobilized. Then, the liver parenchyma was transected and the branches of the hepatic veins and pedicles encountered were clipped and divided. The lesion was meticulously separated from the vascular structures and liver parenchyma and completely resected. The raw surface was treated with bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed. Finally, the specimens were packed in a specimen bag and removed. The raw surface was packed with biological hemostatic materials, and drainage tubes were routinely placed.
arm group label: laparoscopic surgery
intervention type: Procedure
intervention name: Open surgery
description: Patients were placed in the supine position and received intravenous inhalation combined with anesthesia. The intermittent Pringle's maneuver was carried out when necessary. Routinely, a reversed L-shape incision was performed. Cholecystectomy was performed routinely. First, the liver was mobilized. Then, the liver parenchyma was transected and the branches of the hepatic veins and pedicles encountered were clipped and divided. The lesion was meticulously separated from the vascular structures and liver parenchyma and completely resected. The raw surface was treated with bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed. Finally, the specimens were packed in a specimen bag and removed. The raw surface was packed with biological hemostatic materials, and drainage tubes were routinely placed.
arm group label: Open surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shuguo Zheng, M.D.
role: Study Director
affiliation: Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery, Southwest Hospital, Army medical university
last name: Shuguo Zheng, M.D.
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