<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/NCT03820544</url>
  </required_header>
  <id_info>
    <org_study_id>16D.759</org_study_id>
    <nct_id>NCT03820544</nct_id>
  </id_info>
  <brief_title>SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice</brief_title>
  <official_title>Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies the side effects of self expanding metal stent (SEMS) placement before&#xD;
      surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with&#xD;
      severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving&#xD;
      bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe&#xD;
      obstructive jaundice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the 30-day overall complication rates between patients with severe obstructive&#xD;
      jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents&#xD;
      (SEMS) and patients undergoing direct surgical resection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interest in this study changed and it was decided to end enrollment early&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">April 4, 2019</completion_date>
  <primary_completion_date type="Actual">July 24, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complication Rates of Grade III or Higher</measure>
    <time_frame>At 30 days post-surgery</time_frame>
    <description>The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraoperative Estimated Blood Loss</measure>
    <time_frame>At time of surgery</time_frame>
    <description>Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>SEMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care surgical resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo standard of care surgical resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Retrograde Cholangiopancreatography</intervention_name>
    <description>Undergo ERCP with SEMS placement</description>
    <arm_group_label>SEMS</arm_group_label>
    <other_name>ERCP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Undergo standard of care surgical resection</description>
    <arm_group_label>Standard of care surgical resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department&#xD;
             of Surgery per their standard of care&#xD;
&#xD;
          -  Serum bilirubin &gt; 10 mg/dl&#xD;
&#xD;
          -  Adequate birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with evidence of distant metastasis on computed tomography (CT) or magnetic&#xD;
             resonance imaging (MRI)&#xD;
&#xD;
          -  Patients anticipated to require vascular reconstruction&#xD;
&#xD;
          -  Patients with cholangitis&#xD;
&#xD;
          -  Patients for whom surgery is deemed inappropriate by surgeon&#xD;
&#xD;
          -  Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL&#xD;
&#xD;
          -  Patients who previously underwent biliary decompression for cholangitis by ERCP or&#xD;
             percutaneous transhepatic cholangiography (PTC)&#xD;
&#xD;
          -  Patients with low performance score (Karnofsky performance status scale &lt; 50)&#xD;
&#xD;
          -  Patients with known preexisting liver disease with associated elevated bilirubin&#xD;
&#xD;
          -  Patients who are pregnant or actively breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Kowalski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sidney Kimmel Cancer Center at Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sidney Kimmel Cancer Center at Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <results_first_submitted>August 8, 2019</results_first_submitted>
  <results_first_submitted_qc>September 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 10, 2019</results_first_posted>
  <last_update_submitted>September 20, 2019</last_update_submitted>
  <last_update_submitted_qc>September 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Jaundice</mesh_term>
    <mesh_term>Jaundice, Obstructive</mesh_term>
  </condition_browse>
  <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>February 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03820544/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SEMS</title>
          <description>Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.&#xD;
Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care Surgical Resection</title>
          <description>Patients undergo standard of care surgical resection.&#xD;
Standard of care: Undergo standard of care surgical resection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </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>SEMS</title>
          <description>Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.&#xD;
Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care Surgical Resection</title>
          <description>Patients undergo standard of care surgical resection.&#xD;
Standard of care: Undergo standard of care surgical resection</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="2"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</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>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complication Rates of Grade III or Higher</title>
        <description>The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.</description>
        <time_frame>At 30 days post-surgery</time_frame>
        <population>Due to the low enrollment number to this study, statistical analysis was not conducted due to insufficient data collected to run analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>SEMS</title>
            <description>Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.&#xD;
Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Surgical Resection</title>
            <description>Patients undergo standard of care surgical resection.&#xD;
Standard of care: Undergo standard of care surgical resection</description>
          </group>
        </group_list>
        <measure>
          <title>Complication Rates of Grade III or Higher</title>
          <description>The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.</description>
          <population>Due to the low enrollment number to this study, statistical analysis was not conducted due to insufficient data collected to run analyses.</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>Primary</type>
        <title>Intraoperative Estimated Blood Loss</title>
        <description>Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.</description>
        <time_frame>At time of surgery</time_frame>
        <population>Due to the low enrollment number to this study, statistical analysis was not conducted due to insufficient data collected to run analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>SEMS</title>
            <description>Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.&#xD;
Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Surgical Resection</title>
            <description>Patients undergo standard of care surgical resection.&#xD;
Standard of care: Undergo standard of care surgical resection</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoperative Estimated Blood Loss</title>
          <description>Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.</description>
          <population>Due to the low enrollment number to this study, statistical analysis was not conducted due to insufficient data collected to run analyses.</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_list>

    <reported_events>
      <time_frame>1 year after surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SEMS</title>
          <description>Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.&#xD;
Endoscopic Retrograde Cholangiopancreatography: Undergo ERCP with SEMS placement</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care Surgical Resection</title>
          <description>Patients undergo standard of care surgical resection.&#xD;
Standard of care: Undergo standard of care surgical resection</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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </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>Thomas Kowalski, MD</name_or_title>
      <organization>Sidney Kimmel Cancer Center at Thomas Jefferson University</organization>
      <phone>215-955-9396</phone>
      <email>Thomas.Kowalski@jefferson.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/NCT03820544
org study id: 16D.759
nct id: NCT03820544
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial studies the side effects of self expanding metal stent (SEMS) placement before
      surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with
      severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving
      bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe
      obstructive jaundice.
PRIMARY OBJECTIVES:

      I. To compare the 30-day overall complication rates between patients with severe obstructive
      jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents
      (SEMS) and patients undergoing direct surgical resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Complication Rates of Grade III or Higher
time frame: At 30 days post-surgery
description: The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
measure: Intraoperative Estimated Blood Loss
time frame: At time of surgery
description: Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.
arm group label: SEMS
arm group type: Experimental
description: Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.
arm group label: Standard of care surgical resection
arm group type: Active Comparator
description: Patients undergo standard of care surgical resection.
intervention type: Procedure
intervention name: Endoscopic Retrograde Cholangiopancreatography
description: Undergo ERCP with SEMS placement
arm group label: SEMS
other name: ERCP
intervention type: Other
intervention name: Standard of care
description: Undergo standard of care surgical resection
arm group label: Standard of care surgical resection
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Kowalski, MD
role: Principal Investigator
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Jaundice
mesh term: Jaundice, Obstructive
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 