<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/NCT03297099</url>
  </required_header>
  <id_info>
    <org_study_id>SWHZSG006</org_study_id>
    <secondary_id>Zhengshuguo</secondary_id>
    <nct_id>NCT03297099</nct_id>
  </id_info>
  <brief_title>Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis</brief_title>
  <official_title>A Prospective Cohort Study: Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis</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 indication of laparoscopic surgery is mainly for early regional type hepatolithiasis.&#xD;
      Open surgery is the traditional treatment method for heptolithiasis. Da Vinci surgical robot&#xD;
      can overcome limitations of conventional laparoscopic surgery in terms of vision and&#xD;
      instrumentation flexibility, making the minimally invasive treatment of complex&#xD;
      hepatolithiasis possible. The study aimed to evaluate the safety, feasibility, and efficacy&#xD;
      of robot assist laparoscopic surgery for the treatment of complicated hepatolithiasis by&#xD;
      contrast of open procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Robot-assisted laparoscopic operation is a safe and feasible treatment for selected patients&#xD;
      with complicated hepatolithiasis, with an advantage over open surgery in the field of&#xD;
      intraoperative blood loss, less hilar occlusion, lower transfusion rate, less postoperative&#xD;
      hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</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>initial stone clearance rate</measure>
    <time_frame>during the operation</time_frame>
    <description>rate of the removal of the stones from intrahepatic bile duct identified by ultrasonic or computed tomography or magnetic resonance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraoperative parameters</measure>
    <time_frame>during the operation</time_frame>
    <description>operation time, intraoperative blood loss, rate of blood transfusion</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">60</enrollment>
  <condition>Hepatolithiasis</condition>
  <arm_group>
    <arm_group_label>Robot-assisted Laparoscopic operation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Da Vinci surgical robot can overcome limitations of conventional laparoscopic surgery in terms of vision and instrumentation flexibility, making the minimally invasive treatment of complex hepatolithiasis possible.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis. Open surgery is the traditional treatment method for heptolithiasis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robot-assisted Laparoscopic operation</intervention_name>
    <description>Thirty patients with hepatolithiasis were selected and divided into robot group as described in the detailed description. Under general anesthesia, the patient was placed in a supine 30-degree reverse Trendelengburg position with both legs separating. The surgeon work on the console, and assist surgeon stand between legs. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.</description>
    <arm_group_label>Robot-assisted Laparoscopic operation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open surgery</intervention_name>
    <description>surgery group as described in the detailed description.Open surgery was performed under general anesthesia with the patient in the supine position. Routinely, a reversed L-shape incision was performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.</description>
    <arm_group_label>Open surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with intrahepatic bile duct stones or hepatolithiasis.&#xD;
&#xD;
          2. Liver function &gt; Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the&#xD;
             residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open&#xD;
             hepatectomy were achieved&#xD;
&#xD;
          3. Age: Between 18 to 70 years&#xD;
&#xD;
          4. Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition&#xD;
             or hilar biliary fibrosis / stenosis&#xD;
&#xD;
          5. Patients with good general condition, the conditions of open Anatomical Hepatectomy&#xD;
             were achieved&#xD;
&#xD;
          6. Other organ lesions and previous biliary tract operation is not the absolute exclusion&#xD;
             criteria&#xD;
&#xD;
          7. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with bad general condition or important organ lesions, liver resection could&#xD;
             not be tolerated&#xD;
&#xD;
          2. Age:Younger than 18 or more than 70 years old&#xD;
&#xD;
          3. Malignant tumor recurrence within one month postoperation&#xD;
&#xD;
          4. Complicated case need to get emergency operation&#xD;
&#xD;
          5. Contraindication of laparoscopy: Combined with complicated acute cholangitis, repeated&#xD;
             biliary tract operation, heavy intra-abdominal adhesion, Trocar can not be placed in.&#xD;
             Artificial pneumoperitoneum could not be tolerated&#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</last_name>
    <role>Study Director</role>
    <affiliation>Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shuguo Zheng</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, Professor</last_name>
      <phone>0086-13508308676</phone>
      <email>shuguozh@yahoo.com.cn</email>
    </contact>
    <investigator>
      <last_name>Shuguo Zheng, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</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>robot-assisted laparosocpic</keyword>
  <keyword>hepatectomy</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/NCT03297099
org study id: SWHZSG006
secondary id: Zhengshuguo
nct id: NCT03297099
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis.
      Open surgery is the traditional treatment method for heptolithiasis. Da Vinci surgical robot
      can overcome limitations of conventional laparoscopic surgery in terms of vision and
      instrumentation flexibility, making the minimally invasive treatment of complex
      hepatolithiasis possible. The study aimed to evaluate the safety, feasibility, and efficacy
      of robot assist laparoscopic surgery for the treatment of complicated hepatolithiasis by
      contrast of open procedures.
Robot-assisted laparoscopic operation is a safe and feasible treatment for selected patients
      with complicated hepatolithiasis, with an advantage over open surgery in the field of
      intraoperative blood loss, less hilar occlusion, lower transfusion rate, less postoperative
      hospital stay.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: initial stone clearance rate
time frame: during the operation
description: rate of the removal of the stones from intrahepatic bile duct identified by ultrasonic or computed tomography or magnetic resonance
measure: intraoperative parameters
time frame: during the operation
description: operation time, intraoperative blood loss, rate of blood transfusion
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: Robot-assisted Laparoscopic operation
arm group type: Experimental
description: Da Vinci surgical robot can overcome limitations of conventional laparoscopic surgery in terms of vision and instrumentation flexibility, making the minimally invasive treatment of complex hepatolithiasis possible.
arm group label: Open surgery
arm group type: Active Comparator
description: The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis. Open surgery is the traditional treatment method for heptolithiasis.
intervention type: Procedure
intervention name: Robot-assisted Laparoscopic operation
description: Thirty patients with hepatolithiasis were selected and divided into robot group as described in the detailed description. Under general anesthesia, the patient was placed in a supine 30-degree reverse Trendelengburg position with both legs separating. The surgeon work on the console, and assist surgeon stand between legs. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.
arm group label: Robot-assisted Laparoscopic operation
intervention type: Procedure
intervention name: open surgery
description: surgery group as described in the detailed description.Open surgery was performed under general anesthesia with the patient in the supine position. Routinely, a reversed L-shape incision was performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.
arm group label: Open surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shuguo Zheng
role: Study Director
affiliation: Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
last name: Shuguo Zheng
phone: 0086-13508308676
email: shuguozh@yahoo.com.cn
facility: 
status: Recruiting
contact: 
investigator: 
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