<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/NCT02204124</url>
  </required_header>
  <id_info>
    <org_study_id>201311146</org_study_id>
    <nct_id>NCT02204124</nct_id>
  </id_info>
  <brief_title>Whipple Procedure: Standard of Care vs. Thunderbeat</brief_title>
  <official_title>Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation,&#xD;
      and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess&#xD;
      whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative&#xD;
      morbidity (the presence of illness or disease). The findings will then be compared to&#xD;
      patients whose Whipple procedure will be performed using conventional dissection and&#xD;
      hemostasis techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the pancreas is fed by many vessels, it is necessary to use lots of ligatures, clips and&#xD;
      sutures for hemostasis after dissection. This dissection technique is very time consuming and&#xD;
      requires numerous changes of instruments. The devices the investigators currently have&#xD;
      available for use in the operating suite are EnSeal and LigaSure. A new type of surgical&#xD;
      scissors that delivers ultrasonically generated frictional heat energy and electrically&#xD;
      generated bipolar energy simultaneously, known as the Thunderbeat™ (Olympus, Japan), is now&#xD;
      an available alternative for dissection and hemostasis.&#xD;
&#xD;
      Thunderbeat™ was provided FDA clearance in March 2012 for use in open, laparoscopic, and&#xD;
      endoscopic surgery, or in any procedure in which cutting, vessel ligation (sealing and&#xD;
      cutting), coagulation, grasping and dissection is performed.&#xD;
&#xD;
      The Thunderbeat™ device provides the first integration of both bipolar and ultrasonic&#xD;
      energies delivered simultaneously from a single multi-functional instrument. This integration&#xD;
      provides the surgeon the ability to rapidly cut tissue with ultrasonic energy and to create&#xD;
      reliable vessel seals with bipolar energy without having to change devices. The current is&#xD;
      provided by a special generator and contains a very high capacity with a low voltage. The&#xD;
      body's proteins, such as collagen and elastin, are converted so a permanently sealed zone&#xD;
      results. As the tissue between the branches is sealed, lateral thermic tissue damages can be&#xD;
      limited to a minimum. Several authors have described a tendency of reduced intraoperative&#xD;
      blood loss with bipolar energy devices. Other trials show reduced operating time when a&#xD;
      bipolar device is utilized in several surgical procedures, such as thyroid, hepatic,&#xD;
      urologic, hemorrhoidectomy and gynecology surgery.&#xD;
&#xD;
      Correct dissection in the operating field is very important to avert secondary bleeding or&#xD;
      other complications, which might cause re-operation or elevate the patients' morbidity and&#xD;
      mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal Investigator and Study Sponsor decided to terminate the study early&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">August 23, 2017</completion_date>
  <primary_completion_date type="Actual">August 23, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The participants will be blinded to the assigned operating technique.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Operative Blood Loss</measure>
    <time_frame>Day of surgery</time_frame>
    <description>The measurement of estimated blood loss (EBL) will come from the intraoperative anesthesia notes where (EBL) is recorded during each surgical procedure&#xD;
The estimate of operative blood loss is measured by volume in the suction canisters and pads and is historically documented by the operative nursing staff during the operation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-op Morbidity</measure>
    <time_frame>Up to 90 days postoperatively</time_frame>
    <description>-This is a prospective study to evaluate post-operative morbidity following use of the ThunderbeatTM device during the Whipple procedure. This will be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative Time</measure>
    <time_frame>Day of surgery</time_frame>
    <description>-Operation time measured from the beginning of the surgical procedure (incision of the skin) to the end of the surgical procedure (closure of the skin).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost Using Thunderbeat Device</measure>
    <time_frame>Up to 90 days postoperatively</time_frame>
    <description>-Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthesia Time</measure>
    <time_frame>Day of surgery</time_frame>
    <description>-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Perioperative Complications</measure>
    <time_frame>Day of surgery</time_frame>
    <description>-Complications experienced during surgery will be reviewed including:&#xD;
Iatrogenic injury&#xD;
need for conversion from laparoscopic approach to open procedure&#xD;
need for the use of other hemostatic devices or therapies&#xD;
intraoperative requirement of blood product transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Postoperative Complications</measure>
    <time_frame>Up to 90 days postoperatively</time_frame>
    <description>-Complications experienced after surgery will be reviewed including:&#xD;
secondary bleeding/hematoma&#xD;
wound infection&#xD;
gastroparesis&#xD;
postoperative pancreatic fistula&#xD;
intraabdominal abscess&#xD;
anastomotic leakage&#xD;
re-intervention (operational)&#xD;
postop requirement for blood product transfusion&#xD;
hospital mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <condition>Bile Duct Carcinoma</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thunderbeat™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>-In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thunderbeat</intervention_name>
    <description>Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
    <arm_group_label>Thunderbeat™</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard of care scissors, ligatures, clips, and sutures</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo an elective open or laparoscopic Whipple procedure&#xD;
&#xD;
          -  At least 22 years of age.&#xD;
&#xD;
          -  Karnofsky performance status greater than or equal to 80%.&#xD;
&#xD;
          -  Able to understand and willing to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding.&#xD;
&#xD;
          -  Surgeon's opinion at the time of dissection that the subject's well being (e.g.&#xD;
             bleeding or other independent acute health problems) would be compromised.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Hawkins, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>July 20, 2018</results_first_submitted>
  <results_first_submitted_qc>August 22, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 19, 2018</results_first_posted>
  <last_update_submitted>August 22, 2018</last_update_submitted>
  <last_update_submitted_qc>August 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Whipple procedure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ductal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 14, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT02204124/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study opened to participant enrollment on 01/01/2015 and closed to participant enrollment on 08/09/2017.</recruitment_details>
      <pre_assignment_details>There were 44 enrolled to the study. 12 were enrolled but were not randomized to an arm and did not start the study due to reasons such as ineligibility, physician discretion, and because the Thunderbeat was not in the operating room.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
        </group>
        <group group_id="P2">
          <title>Thunderbeat™</title>
          <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="19"/>
              </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>Control Group</title>
          <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
        </group>
        <group group_id="B2">
          <title>Thunderbeat™</title>
          <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</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="13"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="32"/>
          </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="64.6" spread="11.9"/>
                    <measurement group_id="B2" value="64.8" spread="11.3"/>
                    <measurement group_id="B3" value="64.7" spread="11.4"/>
                  </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="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Received Neoadjuvant Therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI) &gt; 30 kg/m^2</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Operative Blood Loss</title>
        <description>The measurement of estimated blood loss (EBL) will come from the intraoperative anesthesia notes where (EBL) is recorded during each surgical procedure&#xD;
The estimate of operative blood loss is measured by volume in the suction canisters and pads and is historically documented by the operative nursing staff during the operation.</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Thunderbeat™</title>
            <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Blood Loss</title>
          <description>The measurement of estimated blood loss (EBL) will come from the intraoperative anesthesia notes where (EBL) is recorded during each surgical procedure&#xD;
The estimate of operative blood loss is measured by volume in the suction canisters and pads and is historically documented by the operative nursing staff during the operation.</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="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="263.5" spread="190.0"/>
                    <measurement group_id="O2" value="480.2" spread="300.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.032</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-op Morbidity</title>
        <description>-This is a prospective study to evaluate post-operative morbidity following use of the ThunderbeatTM device during the Whipple procedure. This will be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.</description>
        <time_frame>Up to 90 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Thunderbeat™</title>
            <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-op Morbidity</title>
          <description>-This is a prospective study to evaluate post-operative morbidity following use of the ThunderbeatTM device during the Whipple procedure. This will be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.513</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operative Time</title>
        <description>-Operation time measured from the beginning of the surgical procedure (incision of the skin) to the end of the surgical procedure (closure of the skin).</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Thunderbeat™</title>
            <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Time</title>
          <description>-Operation time measured from the beginning of the surgical procedure (incision of the skin) to the end of the surgical procedure (closure of the skin).</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="220" lower_limit="143" upper_limit="296"/>
                    <measurement group_id="O2" value="270" lower_limit="183" upper_limit="491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost Using Thunderbeat Device</title>
        <description>-Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively</description>
        <time_frame>Up to 90 days postoperatively</time_frame>
        <population>The data for this outcome measure was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Thunderbeat™</title>
            <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
          </group>
        </group_list>
        <measure>
          <title>Cost Using Thunderbeat Device</title>
          <description>-Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively</description>
          <population>The data for this outcome measure was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anesthesia Time</title>
        <description>-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Thunderbeat™</title>
            <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
          </group>
        </group_list>
        <measure>
          <title>Anesthesia Time</title>
          <description>-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="282.7" spread="50.8"/>
                    <measurement group_id="O2" value="357.3" spread="89.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.013</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Perioperative Complications</title>
        <description>-Complications experienced during surgery will be reviewed including:&#xD;
Iatrogenic injury&#xD;
need for conversion from laparoscopic approach to open procedure&#xD;
need for the use of other hemostatic devices or therapies&#xD;
intraoperative requirement of blood product transfusion</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Thunderbeat™</title>
            <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Perioperative Complications</title>
          <description>-Complications experienced during surgery will be reviewed including:&#xD;
Iatrogenic injury&#xD;
need for conversion from laparoscopic approach to open procedure&#xD;
need for the use of other hemostatic devices or therapies&#xD;
intraoperative requirement of blood product transfusion</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.132</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Postoperative Complications</title>
        <description>-Complications experienced after surgery will be reviewed including:&#xD;
secondary bleeding/hematoma&#xD;
wound infection&#xD;
gastroparesis&#xD;
postoperative pancreatic fistula&#xD;
intraabdominal abscess&#xD;
anastomotic leakage&#xD;
re-intervention (operational)&#xD;
postop requirement for blood product transfusion&#xD;
hospital mortality</description>
        <time_frame>Up to 90 days postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
          </group>
          <group group_id="O2">
            <title>Thunderbeat™</title>
            <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Postoperative Complications</title>
          <description>-Complications experienced after surgery will be reviewed including:&#xD;
secondary bleeding/hematoma&#xD;
wound infection&#xD;
gastroparesis&#xD;
postoperative pancreatic fistula&#xD;
intraabdominal abscess&#xD;
anastomotic leakage&#xD;
re-intervention (operational)&#xD;
postop requirement for blood product transfusion&#xD;
hospital mortality</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Readmission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mortality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bleeding/hematoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wound infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastroparesis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pancreatic fistula</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraabdominal abscess</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anastomotic leakage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood product transfusion (anemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #1 is for readmission</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.975</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #2 is for wound infection.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.401</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #3 is for gastroparesis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.975</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #4 is for pancreatic fistula.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.401</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #5 is for intraabdominal abscess.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.219</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #6 is for anastomotic leakage.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.401</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis #7 is for blood product transfusion (anemia).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.219</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>-Adverse events were collected from the time of surgery through 90 days following completion of surgery.</time_frame>
      <desc>-Surgical complications will not be considered adverse events associated with the study, unless unanticipated and possibly related to the use of the Thunderbeat device.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.</description>
        </group>
        <group group_id="E2">
          <title>Thunderbeat™</title>
          <description>In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).&#xD;
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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>
    <point_of_contact>
      <name_or_title>William Hawkins, M.D.</name_or_title>
      <organization>Washington University School of Medicine</organization>
      <phone>314-286-0702</phone>
      <email>hawkinsw@wustl.edu</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/NCT02204124
org study id: 201311146
nct id: NCT02204124
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation,
      and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess
      whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative
      morbidity (the presence of illness or disease). The findings will then be compared to
      patients whose Whipple procedure will be performed using conventional dissection and
      hemostasis techniques.
As the pancreas is fed by many vessels, it is necessary to use lots of ligatures, clips and
      sutures for hemostasis after dissection. This dissection technique is very time consuming and
      requires numerous changes of instruments. The devices the investigators currently have
      available for use in the operating suite are EnSeal and LigaSure. A new type of surgical
      scissors that delivers ultrasonically generated frictional heat energy and electrically
      generated bipolar energy simultaneously, known as the Thunderbeat™ (Olympus, Japan), is now
      an available alternative for dissection and hemostasis.

      Thunderbeat™ was provided FDA clearance in March 2012 for use in open, laparoscopic, and
      endoscopic surgery, or in any procedure in which cutting, vessel ligation (sealing and
      cutting), coagulation, grasping and dissection is performed.

      The Thunderbeat™ device provides the first integration of both bipolar and ultrasonic
      energies delivered simultaneously from a single multi-functional instrument. This integration
      provides the surgeon the ability to rapidly cut tissue with ultrasonic energy and to create
      reliable vessel seals with bipolar energy without having to change devices. The current is
      provided by a special generator and contains a very high capacity with a low voltage. The
      body's proteins, such as collagen and elastin, are converted so a permanently sealed zone
      results. As the tissue between the branches is sealed, lateral thermic tissue damages can be
      limited to a minimum. Several authors have described a tendency of reduced intraoperative
      blood loss with bipolar energy devices. Other trials show reduced operating time when a
      bipolar device is utilized in several surgical procedures, such as thyroid, hepatic,
      urologic, hemorrhoidectomy and gynecology surgery.

      Correct dissection in the operating field is very important to avert secondary bleeding or
      other complications, which might cause re-operation or elevate the patients' morbidity and
      mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: The participants will be blinded to the assigned operating technique.
measure: Operative Blood Loss
time frame: Day of surgery
description: The measurement of estimated blood loss (EBL) will come from the intraoperative anesthesia notes where (EBL) is recorded during each surgical procedure
The estimate of operative blood loss is measured by volume in the suction canisters and pads and is historically documented by the operative nursing staff during the operation.
measure: Post-op Morbidity
time frame: Up to 90 days postoperatively
description: -This is a prospective study to evaluate post-operative morbidity following use of the ThunderbeatTM device during the Whipple procedure. This will be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.
measure: Operative Time
time frame: Day of surgery
description: -Operation time measured from the beginning of the surgical procedure (incision of the skin) to the end of the surgical procedure (closure of the skin).
measure: Cost Using Thunderbeat Device
time frame: Up to 90 days postoperatively
description: -Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively
measure: Anesthesia Time
time frame: Day of surgery
description: -Anesthesia time measured from the initiation of anesthesia induction to the time of extubation
measure: Number of Participants Who Experienced Perioperative Complications
time frame: Day of surgery
description: -Complications experienced during surgery will be reviewed including:
Iatrogenic injury
need for conversion from laparoscopic approach to open procedure
need for the use of other hemostatic devices or therapies
intraoperative requirement of blood product transfusion
measure: Number of Participants Who Experienced Postoperative Complications
time frame: Up to 90 days postoperatively
description: -Complications experienced after surgery will be reviewed including:
secondary bleeding/hematoma
wound infection
gastroparesis
postoperative pancreatic fistula
intraabdominal abscess
anastomotic leakage
re-intervention (operational)
postop requirement for blood product transfusion
hospital mortality
arm group label: Control Group
arm group type: Active Comparator
description: In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
arm group label: Thunderbeat™
arm group type: Experimental
description: -In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
intervention type: Device
intervention name: Thunderbeat
description: Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
arm group label: Thunderbeat™
intervention type: Device
intervention name: Standard of care scissors, ligatures, clips, and sutures
arm group label: Control Group
criteria: 
gender: All
minimum age: 22 Years
maximum age: 75 Years
healthy volunteers: No
last name: William Hawkins, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Carcinoma, Ductal
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 