<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/NCT02197481</url>
  </required_header>
  <id_info>
    <org_study_id>ahykdxdefsyy10</org_study_id>
    <nct_id>NCT02197481</nct_id>
  </id_info>
  <brief_title>Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial</brief_title>
  <official_title>BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Second Hospital of Anhui Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps&#xD;
      hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic&#xD;
      resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Blood loss and the need for blood transfusions during the liver transection have&#xD;
      shown to be correlated with higher morbidity and mortality rates and with worsen prognosis.&#xD;
      Various devices of liver parenchymal transection have been developed with a view to reducing&#xD;
      the intraoperative blood loss. However, to the present there is no randomized controlled&#xD;
      trial evaluating the technique of BiClamp forceps during the liver transection. The goal of&#xD;
      the present study was to evaluate the safety and effectiveness of BiClamp forceps transection&#xD;
      in comparison to the clamp crushing technique in patients offered liver resection.&#xD;
&#xD;
      Intervention: One hundred patients with hepatobiliary disease need undergo hepatectomy at&#xD;
      Anhui medical university were selected and divided into BiClamp forceps hepatectomy group and&#xD;
      clamp-crushing hepatectomy group, each group contains 50 cases.&#xD;
&#xD;
      Results:&#xD;
&#xD;
        1. Clinical data include: blood loss during liver transection, total blood loss, blood&#xD;
           transfusion, hospital stay, morbidity, mortality, biliary leakage, postoperative liver&#xD;
           function, liver transection time, operation time, resection margins, need for portal&#xD;
           trial clamping.&#xD;
&#xD;
        2. Statistical method: groups t-test, univariate/multivariate analysis, logistic regression&#xD;
           analysis, mixed linear regression and Cox survival analysis were used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 3</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>The Total Blood Loss</measure>
    <time_frame>an expected average of 80 minutes</time_frame>
    <description>Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Liver Transection Time</measure>
    <time_frame>an expected average of 40 minutes</time_frame>
    <description>liver transection time was calculated from the beginning to the end of the liver resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days</time_frame>
    <description>Operative mortality was defined as any death resulting from a complication during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biliary Leakage</measure>
    <time_frame>90 days</time_frame>
    <description>Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Postoperative Hospital Stay</measure>
    <time_frame>an expected average of 12 days</time_frame>
    <description>Time from day of operation to day of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring a Blood Transfusion</measure>
    <time_frame>2 days</time_frame>
    <description>Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Bilirubin</measure>
    <time_frame>3 postoperative day</time_frame>
    <description>serum total bilirubin on 3 postoperative day (umol/L)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Hepatobiliary Disease</condition>
  <arm_group>
    <arm_group_label>Clamp-Crushing technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BiClamp forceps hepatectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Clamp-Crushing technique</intervention_name>
    <description>Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
    <arm_group_label>Clamp-Crushing technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BiClamp forceps</intervention_name>
    <description>liver transection during hepatectomy by BiClamp forceps</description>
    <arm_group_label>BiClamp forceps hepatectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both male and female, aged 18 or older&#xD;
&#xD;
          -  Patients scheduled to undergo hepatic resection for some benign or malignant&#xD;
             hepatobiliary disease&#xD;
&#xD;
          -  Child-Pugh class A or B liver function&#xD;
&#xD;
          -  BiClamp forceps hepatectomy and clamp-crushing feasible based on preoperative imaging&#xD;
&#xD;
          -  No tumor invasion the main vein, hepatic artery and vein and major inferior vena cava&#xD;
&#xD;
          -  No extrahepatic metastasis&#xD;
&#xD;
          -  Voluntary participation in the study, and informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years or&gt; 65 years , pregnant or lactating women&#xD;
&#xD;
          -  Preoperative liver function evaluation: Child-Pugh C grade&#xD;
&#xD;
          -  Laparoscopic hepatectomy&#xD;
&#xD;
          -  Extrahepatic metastasis&#xD;
&#xD;
          -  Tumor invasion the main vein, hepatic artery and vein and major inferior vena cava&#xD;
&#xD;
          -  The patient refused to sign the informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geng Xiaoping</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Hospital of Anhui Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the Second Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Kooby DA, Stockman J, Ben-Porat L, Gonen M, Jarnagin WR, Dematteo RP, Tuorto S, Wuest D, Blumgart LH, Fong Y. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg. 2003 Jun;237(6):860-9; discussion 869-70. doi: 10.1097/01.SLA.0000072371.95588.DA.</citation>
    <PMID>12796583</PMID>
  </results_reference>
  <results_reference>
    <citation>Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.</citation>
    <PMID>19160307</PMID>
  </results_reference>
  <results_reference>
    <citation>Itoh S, Fukuzawa K, Shitomi Y, Okamoto M, Kinoshita T, Taketomi A, Shirabe K, Wakasugi K, Maehara Y. Impact of the VIO system in hepatic resection for patients with hepatocellular carcinoma. Surg Today. 2012 Dec;42(12):1176-82. doi: 10.1007/s00595-012-0306-6. Epub 2012 Sep 20.</citation>
    <PMID>22993104</PMID>
  </results_reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>September 7, 2016</results_first_submitted>
  <results_first_submitted_qc>May 6, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 14, 2017</results_first_posted>
  <last_update_submitted>May 6, 2017</last_update_submitted>
  <last_update_submitted_qc>May 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Hospital of Anhui Medical University</investigator_affiliation>
    <investigator_full_name>xpgeng</investigator_full_name>
    <investigator_title>vice-president</investigator_title>
  </responsible_party>
  <keyword>BiClamp forceps hepatectomy</keyword>
  <keyword>Clamp crushing technique</keyword>
  <keyword>Liver parenchyma transection</keyword>
  <keyword>Randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>PMID:25925431</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://www.ncbi.nlm.nih.gov/pubmed/25925431</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligibility criteria included scheduled liver resection for benign or malignant hepatobiliary disease and a minimum age of 18 years.</recruitment_details>
      <pre_assignment_details>Patients undergoing concomitant vascular resection or bile duct resection and those undergoing emergency liver resection were excluded.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Clamp-Crushing Technique</title>
          <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electric knife and blood vessel forceps, but without BiClamp forceps</description>
        </group>
        <group group_id="P2">
          <title>BiClamp Forceps Hepatectomy</title>
          <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43">October 2014</participants>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43">February 2016</participants>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Clamp-Crushing Technique</title>
          <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
        </group>
        <group group_id="B2">
          <title>BiClamp Forceps Hepatectomy</title>
          <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="86"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.12" spread="10.84"/>
                    <measurement group_id="B2" value="55.98" spread="11.30"/>
                    <measurement group_id="B3" value="54.55" spread="11.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Transection surface area</title>
          <units>cm2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.11" spread="40.09"/>
                    <measurement group_id="B2" value="65.16" spread="44.30"/>
                    <measurement group_id="B3" value="67.14" spread="42.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Specimen weight</title>
          <units>g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="230.73" spread="191.35"/>
                    <measurement group_id="B2" value="193.25" spread="182.48"/>
                    <measurement group_id="B3" value="211.99" spread="186.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Total Blood Loss</title>
        <description>Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection</description>
        <time_frame>an expected average of 80 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clamp-Crushing Technique</title>
            <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
          </group>
          <group group_id="O2">
            <title>BiClamp Forceps Hepatectomy</title>
            <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
          </group>
        </group_list>
        <measure>
          <title>The Total Blood Loss</title>
          <description>Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection</description>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="376.73" spread="303.67"/>
                    <measurement group_id="O2" value="339.81" spread="257.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Liver Transection Time</title>
        <description>liver transection time was calculated from the beginning to the end of the liver resection</description>
        <time_frame>an expected average of 40 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clamp-Crushing Technique</title>
            <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
          </group>
          <group group_id="O2">
            <title>BiClamp Forceps Hepatectomy</title>
            <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Transection Time</title>
          <description>liver transection time was calculated from the beginning to the end of the liver resection</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.51" spread="12.19"/>
                    <measurement group_id="O2" value="26.21" spread="17.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>Operative mortality was defined as any death resulting from a complication during surgery</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clamp-Crushing Technique</title>
            <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
          </group>
          <group group_id="O2">
            <title>BiClamp Forceps Hepatectomy</title>
            <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>Operative mortality was defined as any death resulting from a complication during surgery</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Morbidity</title>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clamp-Crushing Technique</title>
            <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
          </group>
          <group group_id="O2">
            <title>BiClamp Forceps Hepatectomy</title>
            <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
          </group>
        </group_list>
        <measure>
          <title>Morbidity</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biliary Leakage</title>
        <description>Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clamp-Crushing Technique</title>
            <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
          </group>
          <group group_id="O2">
            <title>BiClamp Forceps Hepatectomy</title>
            <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
          </group>
        </group_list>
        <measure>
          <title>Biliary Leakage</title>
          <description>Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Postoperative Hospital Stay</title>
        <description>Time from day of operation to day of discharge</description>
        <time_frame>an expected average of 12 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clamp-Crushing Technique</title>
            <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
          </group>
          <group group_id="O2">
            <title>BiClamp Forceps Hepatectomy</title>
            <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Postoperative Hospital Stay</title>
          <description>Time from day of operation to day of discharge</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.65" spread="2.02"/>
                    <measurement group_id="O2" value="8.81" spread="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring a Blood Transfusion</title>
        <description>Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively</description>
        <time_frame>2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clamp-Crushing Technique</title>
            <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
          </group>
          <group group_id="O2">
            <title>BiClamp Forceps Hepatectomy</title>
            <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring a Blood Transfusion</title>
          <description>Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Bilirubin</title>
        <description>serum total bilirubin on 3 postoperative day (umol/L)</description>
        <time_frame>3 postoperative day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clamp-Crushing Technique</title>
            <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
          </group>
          <group group_id="O2">
            <title>BiClamp Forceps Hepatectomy</title>
            <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
          </group>
        </group_list>
        <measure>
          <title>Total Bilirubin</title>
          <description>serum total bilirubin on 3 postoperative day (umol/L)</description>
          <units>umol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.70" spread="11.34"/>
                    <measurement group_id="O2" value="18.46" spread="17.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Clamp-Crushing Technique</title>
          <description>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted&#xD;
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps</description>
        </group>
        <group group_id="E2">
          <title>BiClamp Forceps Hepatectomy</title>
          <description>The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.&#xD;
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Clavien-Dindo</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title vocab="pleural effusions">pleural effusions</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>biliary leakage</sub_title>
                <description>percutaneous drainage</description>
                <counts group_id="E1" events="43" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" events="43" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>Clavien-Dindo</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>pleural effusions</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="43"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title vocab="Liver failure">Liver failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title vocab="Biliary leakage">Biliary leakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title vocab="Wound infection">Wound infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Owing to the small number of patients, no subgroup analysis based in type of hepatic resection or hepatic portal occlusion, So it is unclear whether the advantage of BiClamp® forceps is applicable to special type hepatic resection subgroups.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr.Jiang-ming Chen</name_or_title>
      <organization>The Second Affiliated Hospital of Anhui Medical University</organization>
      <phone>15855518651 ext 86</phone>
      <email>chenjm10@126.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02197481
org study id: ahykdxdefsyy10
nct id: NCT02197481
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps
      hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic
      resection.
Background: Blood loss and the need for blood transfusions during the liver transection have
      shown to be correlated with higher morbidity and mortality rates and with worsen prognosis.
      Various devices of liver parenchymal transection have been developed with a view to reducing
      the intraoperative blood loss. However, to the present there is no randomized controlled
      trial evaluating the technique of BiClamp forceps during the liver transection. The goal of
      the present study was to evaluate the safety and effectiveness of BiClamp forceps transection
      in comparison to the clamp crushing technique in patients offered liver resection.

      Intervention: One hundred patients with hepatobiliary disease need undergo hepatectomy at
      Anhui medical university were selected and divided into BiClamp forceps hepatectomy group and
      clamp-crushing hepatectomy group, each group contains 50 cases.

      Results:

        1. Clinical data include: blood loss during liver transection, total blood loss, blood
           transfusion, hospital stay, morbidity, mortality, biliary leakage, postoperative liver
           function, liver transection time, operation time, resection margins, need for portal
           trial clamping.

        2. Statistical method: groups t-test, univariate/multivariate analysis, logistic regression
           analysis, mixed linear regression and Cox survival analysis were used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Total Blood Loss
time frame: an expected average of 80 minutes
description: Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection
measure: Liver Transection Time
time frame: an expected average of 40 minutes
description: liver transection time was calculated from the beginning to the end of the liver resection
measure: Mortality
time frame: 90 days
description: Operative mortality was defined as any death resulting from a complication during surgery
measure: Morbidity
time frame: 90 days
measure: Biliary Leakage
time frame: 90 days
description: Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
measure: Duration of Postoperative Hospital Stay
time frame: an expected average of 12 days
description: Time from day of operation to day of discharge
measure: Number of Participants Requiring a Blood Transfusion
time frame: 2 days
description: Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively
measure: Total Bilirubin
time frame: 3 postoperative day
description: serum total bilirubin on 3 postoperative day (umol/L)
arm group label: Clamp-Crushing technique
arm group type: Active Comparator
description: liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
arm group label: BiClamp forceps hepatectomy
arm group type: Experimental
description: The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
intervention type: Procedure
intervention name: Clamp-Crushing technique
description: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
arm group label: Clamp-Crushing technique
intervention type: Device
intervention name: BiClamp forceps
description: liver transection during hepatectomy by BiClamp forceps
arm group label: BiClamp forceps hepatectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Geng Xiaoping
role: Principal Investigator
affiliation: The Second Hospital of Anhui Medical University
facility: 
country: China
citation: Kooby DA, Stockman J, Ben-Porat L, Gonen M, Jarnagin WR, Dematteo RP, Tuorto S, Wuest D, Blumgart LH, Fong Y. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg. 2003 Jun;237(6):860-9; discussion 869-70. doi: 10.1097/01.SLA.0000072371.95588.DA.
PMID: 12796583
citation: Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.
PMID: 19160307
citation: Itoh S, Fukuzawa K, Shitomi Y, Okamoto M, Kinoshita T, Taketomi A, Shirabe K, Wakasugi K, Maehara Y. Impact of the VIO system in hepatic resection for patients with hepatocellular carcinoma. Surg Today. 2012 Dec;42(12):1176-82. doi: 10.1007/s00595-012-0306-6. Epub 2012 Sep 20.
PMID: 22993104
responsible party type: Principal Investigator
investigator affiliation: The Second Hospital of Anhui Medical University
investigator full name: xpgeng
investigator title: vice-president
mesh term: Digestive System Diseases
mesh term: Liver Diseases
sharing ipd: Undecided
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Owing to the small number of patients, no subgroup analysis based in type of hepatic resection or hepatic portal occlusion, So it is unclear whether the advantage of BiClamp® forceps is applicable to special type hepatic resection subgroups.
point of contact: 