<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/NCT02213692</url>
  </required_header>
  <id_info>
    <org_study_id>D2014-051</org_study_id>
    <nct_id>NCT02213692</nct_id>
  </id_info>
  <brief_title>Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method</brief_title>
  <official_title>Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method: A Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hui-Chuan Sun</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blood loss during liver resection significantly associates with short term operative outcome.&#xD;
      The median blood loss during partial liver resection is 700-1200ml in high-volume centers.&#xD;
      Conventional method (crush-clamp) has been a standard technique for liver transection.&#xD;
      Technique advances related to liver transection have contributed to reduction in blood loss.&#xD;
      Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use.&#xD;
      A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased&#xD;
      operative time, blood loss and transfusion requirement, and an increased incidence of&#xD;
      postoperative bile leakage. However, no randomized study has compared the difference between&#xD;
      liver resection using traditional technology and harmonic Scalpel. The objective of this&#xD;
      prospective randomized study is to compare the safety and efficacy of liver resection using&#xD;
      the harmonic scalpel device with the &quot;crush-clamp&quot; technique in respect to blood loss, liver&#xD;
      transection time, hepatic hilum clamping time, hospital stay and postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blood loss during liver resection significantly associates with short term operative outcome.&#xD;
      The median blood loss during partial liver resection is 700-1200ml in high-volume centers.&#xD;
      Conventional method (crush-clamp) has been a standard technique for liver transection.&#xD;
      Technique advances related to liver transection have contributed to reduction in blood loss.&#xD;
      Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use.&#xD;
      A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased&#xD;
      operative time, blood loss and transfusion requirement, and an increased incidence of&#xD;
      postoperative bile leakage. However, no randomized study has compared the difference between&#xD;
      liver resection using traditional technology and harmonic Scalpel. The objective of this&#xD;
      prospective randomized study is to compare the safety and efficacy of liver resection using&#xD;
      the harmonic scalpel device with the &quot;crush-clamp&quot; technique in respect to blood loss, liver&#xD;
      transection time, hepatic hilum clamping time, hospital stay and postoperative complications.&#xD;
      All patients submitted to liver resection are randomized into two groups: those submitted to&#xD;
      liver resection with the use of &quot;crush-clamp&quot; technique. (group Α) and those with the use of&#xD;
      the Harmonic Scalpel device (group Β).&#xD;
&#xD;
      Crush-clamping Method (group A) :Patients submitted to liver resection with the use of&#xD;
      &quot;crush-clamping&quot; technique.&#xD;
&#xD;
      Device: Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate&#xD;
      small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or&#xD;
      vascular clips.&#xD;
&#xD;
      Harmonic Scalpel (group B) :Patients submitted to liver resection with the use of the&#xD;
      Harmonic Scalpel device.Device: liver parenchymal transection is transected by harmonic&#xD;
      scalpel, and small vessels and biliary radicals (&lt;3mm) is also divided by harmonic scalpel.&#xD;
      Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or&#xD;
      vascular clips.&#xD;
&#xD;
      Primary Outcome Measures:&#xD;
&#xD;
      Blood loss during operation [an expected average of 3 hours] operation][Designated as safety&#xD;
      issue: Yes] Postoperative complications including bile leakage, bleeding, morbidity, injured&#xD;
      Liver function [Time Frame: participants will be followed for the duration of hospital stay,&#xD;
      an expected average of 8 days] [Designated as safety issue: Yes]&#xD;
&#xD;
      Secondary Outcome Measures:&#xD;
&#xD;
      Transection time from Mark of the cutting edge to finish disposed of the cutting edge&#xD;
      [Designated as safety issue: No] Hepatic hilar clamping time (Pringle's method) [the duration&#xD;
      of clamping of hepatic hilar] [Designated as safety issue: No] Hospital stay [participants&#xD;
      will be followed for the duration of hospital stay, an expected average of 8 days]&#xD;
      [Designated as safety issue: No] Enrollment: 128 Study Start Date: June 2014 Study Completion&#xD;
      Date: May 2015 Primary Completion Date: May 2015 (Final data collection date for primary&#xD;
      outcome measure)&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Genders Eligible for Study: Both Accepts Healthy Volunteers: No&#xD;
&#xD;
      Criteria:&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
        1. Age ≥18y, and ≤80y;&#xD;
&#xD;
        2. No history of liver resection and radiotherapy&#xD;
&#xD;
        3. Liver function: Child A with a normal prothrombin time (&lt;13 seconds) and international&#xD;
           normalized ratio (INR )(&lt;1.15);&#xD;
&#xD;
        4. Extent of resection ≥2 segment or diameter of tumor (single nodule) ≥ 8cm or cumulative&#xD;
           diameter of tumor (multiple nodule) ≥ 8cm; Eligible patients will be stratified by&#xD;
           resection in left lobe or right lobe.&#xD;
&#xD;
        5. No tumor thrombosis in main trunk or right and left branch of portal vein or major&#xD;
           hepatic vein.&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
        1. Recurrent liver tumor; or simultaneous resection of other organs except gallbladder&#xD;
&#xD;
        2. Prothrombin time &gt; 13seconds;&#xD;
&#xD;
        3. Blood platelets count (BPC) &lt; 60*109&#xD;
&#xD;
        4. Moderate and severe of esophageal varices detected by CT or MRI&#xD;
&#xD;
        5. Diameter of portal vein &gt; 14mm (color ultrasound)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>7 Days</target_duration>
  <primary_outcome>
    <measure>Blood loss</measure>
    <time_frame>intraoperatively operation（an average of 3 hours)</time_frame>
    <description>Amount of blood loss will be assayed during operation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transection time</measure>
    <time_frame>from Mark of the cutting edge to finish disposed of the cutting edge (an average of 1 hour)</time_frame>
    <description>Liver transection time from Mark of the cutting edge to finish disposed of the cutting edge will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic hilar clamping time</measure>
    <time_frame>duration of clamping of hepatic hilar (an average of 30 minutes)</time_frame>
    <description>Hepatic hilar clamping time (Pringle's method) will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>dates from admission to discharge (an average of 8 days)</time_frame>
    <description>Time of hospital stay will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>within 7 days after operation</time_frame>
    <description>Postoperative complications including bile leakage, bleeding, morbidity, injured Liver function will be recorded.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Hepatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Crush-clamping Method (group A)</arm_group_label>
    <description>Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or vascular clips.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Harmonic Scalpel Method (group B)</arm_group_label>
    <description>Liver parenchymal transection is transected by harmonic scalpel, and small vessels and biliary radicals (&lt;3mm) is also divided by harmonic scalpel. Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or vascular clips.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Genders Eligible for Study: Both Accepts Healthy Volunteers: No&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18y, and ≤80y;&#xD;
&#xD;
          2. No history of liver resection and radiotherapy&#xD;
&#xD;
          3. Liver function: Child A with a normal prothrombin time (&lt;13 seconds) and INR (1.15);&#xD;
&#xD;
          4. Extent of resection ≥2 segment or diameter of tumor (single nodule) ≥ 8cm or&#xD;
             cumulative diameter of tumor (multiple nodule) ≥ 8cm; Eligible patients will be&#xD;
             stratified by resection in left lobe or right lobe.&#xD;
&#xD;
          5. No tumor thrombosis in main trunk or right and left branch of portal vein or major&#xD;
             hepatic vein.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Recurrent liver tumor; or simultaneous resection of other organs except gallbladder&#xD;
&#xD;
          2. Prothrombin time &gt; 13S;&#xD;
&#xD;
          3. Blood platelets count (BPC) &lt; 60x109&#xD;
&#xD;
          4. Moderate and severe of esophageal varices detected by CT or MRI&#xD;
&#xD;
          5. Diameter of portal vein &gt; 14mm (color ultrasound)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui Chuan Sun, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jia Fan, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jian Zhou, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shuang Jian Qiu, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guo Ming Shi, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qing Hai Ye, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lu Wang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiao Wu Huang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ning Ren, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jing Xian Yu, Nurse</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yang Xu, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ying Hong Shi, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiao Ying Wang, Asso. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jian Sun, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zheng Wang, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yong Sheng Xiao, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pei Chen, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cheng Huang, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ying Hao Shen, Asso. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>May 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>February 2, 2016</last_update_submitted>
  <last_update_submitted_qc>February 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Hui-Chuan Sun</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Liver Resection</keyword>
  <keyword>Harmonic Scalpel</keyword>
  <keyword>Crush-clamping</keyword>
  <keyword>A Prospective Randomized Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</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/NCT02213692
org study id: D2014-051
nct id: NCT02213692
lead sponsor: 
has dmc: Yes
Blood loss during liver resection significantly associates with short term operative outcome.
      The median blood loss during partial liver resection is 700-1200ml in high-volume centers.
      Conventional method (crush-clamp) has been a standard technique for liver transection.
      Technique advances related to liver transection have contributed to reduction in blood loss.
      Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use.
      A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased
      operative time, blood loss and transfusion requirement, and an increased incidence of
      postoperative bile leakage. However, no randomized study has compared the difference between
      liver resection using traditional technology and harmonic Scalpel. The objective of this
      prospective randomized study is to compare the safety and efficacy of liver resection using
      the harmonic scalpel device with the "crush-clamp" technique in respect to blood loss, liver
      transection time, hepatic hilum clamping time, hospital stay and postoperative complications.
Blood loss during liver resection significantly associates with short term operative outcome.
      The median blood loss during partial liver resection is 700-1200ml in high-volume centers.
      Conventional method (crush-clamp) has been a standard technique for liver transection.
      Technique advances related to liver transection have contributed to reduction in blood loss.
      Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use.
      A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased
      operative time, blood loss and transfusion requirement, and an increased incidence of
      postoperative bile leakage. However, no randomized study has compared the difference between
      liver resection using traditional technology and harmonic Scalpel. The objective of this
      prospective randomized study is to compare the safety and efficacy of liver resection using
      the harmonic scalpel device with the "crush-clamp" technique in respect to blood loss, liver
      transection time, hepatic hilum clamping time, hospital stay and postoperative complications.
      All patients submitted to liver resection are randomized into two groups: those submitted to
      liver resection with the use of "crush-clamp" technique. (group Α) and those with the use of
      the Harmonic Scalpel device (group Β).

      Crush-clamping Method (group A) :Patients submitted to liver resection with the use of
      "crush-clamping" technique.

      Device: Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate
      small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or
      vascular clips.

      Harmonic Scalpel (group B) :Patients submitted to liver resection with the use of the
      Harmonic Scalpel device.Device: liver parenchymal transection is transected by harmonic
      scalpel, and small vessels and biliary radicals (<3mm) is also divided by harmonic scalpel.
      Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or
      vascular clips.

      Primary Outcome Measures:

      Blood loss during operation [an expected average of 3 hours] operation][Designated as safety
      issue: Yes] Postoperative complications including bile leakage, bleeding, morbidity, injured
      Liver function [Time Frame: participants will be followed for the duration of hospital stay,
      an expected average of 8 days] [Designated as safety issue: Yes]

      Secondary Outcome Measures:

      Transection time from Mark of the cutting edge to finish disposed of the cutting edge
      [Designated as safety issue: No] Hepatic hilar clamping time (Pringle's method) [the duration
      of clamping of hepatic hilar] [Designated as safety issue: No] Hospital stay [participants
      will be followed for the duration of hospital stay, an expected average of 8 days]
      [Designated as safety issue: No] Enrollment: 128 Study Start Date: June 2014 Study Completion
      Date: May 2015 Primary Completion Date: May 2015 (Final data collection date for primary
      outcome measure)

      Eligibility:

      Genders Eligible for Study: Both Accepts Healthy Volunteers: No

      Criteria:

      Inclusion Criteria:

        1. Age ≥18y, and ≤80y;

        2. No history of liver resection and radiotherapy

        3. Liver function: Child A with a normal prothrombin time (<13 seconds) and international
           normalized ratio (INR )(<1.15);

        4. Extent of resection ≥2 segment or diameter of tumor (single nodule) ≥ 8cm or cumulative
           diameter of tumor (multiple nodule) ≥ 8cm; Eligible patients will be stratified by
           resection in left lobe or right lobe.

        5. No tumor thrombosis in main trunk or right and left branch of portal vein or major
           hepatic vein.

      Exclusion Criteria:

        1. Recurrent liver tumor; or simultaneous resection of other organs except gallbladder

        2. Prothrombin time > 13seconds;

        3. Blood platelets count (BPC) < 60*109

        4. Moderate and severe of esophageal varices detected by CT or MRI

        5. Diameter of portal vein > 14mm (color ultrasound)
observational model: Case-Control
time perspective: Prospective
measure: Blood loss
time frame: intraoperatively operation（an average of 3 hours)
description: Amount of blood loss will be assayed during operation.
measure: Transection time
time frame: from Mark of the cutting edge to finish disposed of the cutting edge (an average of 1 hour)
description: Liver transection time from Mark of the cutting edge to finish disposed of the cutting edge will be recorded.
measure: Hepatic hilar clamping time
time frame: duration of clamping of hepatic hilar (an average of 30 minutes)
description: Hepatic hilar clamping time (Pringle's method) will be recorded.
measure: Hospital stay
time frame: dates from admission to discharge (an average of 8 days)
description: Time of hospital stay will be recorded.
measure: Postoperative complications
time frame: within 7 days after operation
description: Postoperative complications including bile leakage, bleeding, morbidity, injured Liver function will be recorded.
arm group label: Crush-clamping Method (group A)
description: Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or vascular clips.
arm group label: Harmonic Scalpel Method (group B)
description: Liver parenchymal transection is transected by harmonic scalpel, and small vessels and biliary radicals (<3mm) is also divided by harmonic scalpel. Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or vascular clips.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hui Chuan Sun, Professor
role: Study Chair
affiliation: Fudan University
last name: Jia Fan, Professor
role: Principal Investigator
affiliation: Fudan University
last name: Jian Zhou, Professor
role: Principal Investigator
affiliation: Fudan University
last name: Shuang Jian Qiu, Professor
role: Principal Investigator
affiliation: Fudan University
last name: Guo Ming Shi, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
last name: Qing Hai Ye, Professor
role: Principal Investigator
affiliation: Fudan University
last name: Lu Wang, Professor
role: Principal Investigator
affiliation: Fudan University
last name: Xiao Wu Huang, Professor
role: Principal Investigator
affiliation: Fudan University
last name: Ning Ren, Professor
role: Principal Investigator
affiliation: Fudan University
last name: Jing Xian Yu, Nurse
role: Principal Investigator
affiliation: Fudan University
last name: Yang Xu, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
last name: Ying Hong Shi, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
last name: Xiao Ying Wang, Asso. Prof
role: Principal Investigator
affiliation: Fudan University
last name: Jian Sun, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
last name: Zheng Wang, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
last name: Yong Sheng Xiao, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
last name: Pei Chen, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
last name: Cheng Huang, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
last name: Ying Hao Shen, Asso. Prof.
role: Principal Investigator
affiliation: Fudan University
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Fudan University
investigator full name: Hui-Chuan Sun
investigator title: Professor
mesh term: Liver Neoplasms