<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/NCT02238847</url>
  </required_header>
  <id_info>
    <org_study_id>90905950</org_study_id>
    <secondary_id>E7034</secondary_id>
    <nct_id>NCT02238847</nct_id>
  </id_info>
  <brief_title>Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy</brief_title>
  <official_title>Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to&#xD;
      Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary&#xD;
      obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 24, 2015</start_date>
  <completion_date type="Actual">April 10, 2018</completion_date>
  <primary_completion_date type="Actual">February 21, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms</measure>
    <time_frame>From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)</time_frame>
    <description>Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure-related or Stent-related Serious Adverse Events</measure>
    <time_frame>From stent placement procedure up to one year after stent placement procedure</time_frame>
    <description>Serious adverse events related to the stent placement procedure or to the stent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>During the Stent Placement Procedure</time_frame>
    <description>Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention</measure>
    <time_frame>From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS</time_frame>
    <description>The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Stent Migration</measure>
    <time_frame>At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS</time_frame>
    <description>The number of participants with stent migration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure</measure>
    <time_frame>At the time of curative intent surgery (CIS) (median 110 days to CIS)</time_frame>
    <description>The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement</measure>
    <time_frame>From stent placement to one year after stent placement for participants not undergoing curative intent surgery</time_frame>
    <description>For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>WallFlex Biliary RX Fully Covered Stent System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WallFlex Biliary RX Uncovered Stent System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WallFlex™ Biliary RX Fully Covered/Uncovered Stent System</intervention_name>
    <description>Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
    <arm_group_label>WallFlex Biliary RX Fully Covered Stent System</arm_group_label>
    <arm_group_label>WallFlex Biliary RX Uncovered Stent System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Patient indicated for biliary metal stent placement for the treatment of jaundice&#xD;
             and/or cholestasis&#xD;
&#xD;
          -  Willing and able to comply with the study procedures and provide written informed&#xD;
             consent to participate in the study&#xD;
&#xD;
          -  Suspicion of pancreatic adenocarcinoma&#xD;
&#xD;
          -  Likely indicated for neoadjuvant treatment&#xD;
&#xD;
          -  Distal biliary obstruction consistent with pancreatic cancer&#xD;
&#xD;
          -  Location of distal biliary obstruction such that it would allow the proximal end of a&#xD;
             stent to be positioned at least 2 cm from the hilum&#xD;
&#xD;
          -  Endoscopic and surgical treatment to be provided at the same institution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Benign biliary strictures&#xD;
&#xD;
          -  Malignancy secondary to Intraductal Papillary Mucinous Neoplasm&#xD;
&#xD;
          -  Surgically altered anatomy where ERCP is not possible&#xD;
&#xD;
          -  Previous biliary drainage using a SEMS or multiple plastic stents&#xD;
&#xD;
          -  Contraindications for endoscopic techniques&#xD;
&#xD;
          -  Patients who are currently enrolled in another investigational trial that would&#xD;
             directly interfere with the current study&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yousuke Nakai, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tokyo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dong-Wan Seo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Medical Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CUB Hopital Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>May 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>July 25, 2019</results_first_submitted>
  <results_first_submitted_qc>February 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2020</results_first_posted>
  <last_update_submitted>February 14, 2020</last_update_submitted>
  <last_update_submitted_qc>February 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic</keyword>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Preoperative Biliary Drainage</keyword>
  <keyword>Neoadjuvant Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 14, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT02238847/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 9, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT02238847/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>WallFlex Biliary RX Fully Covered Stent System</title>
          <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
        </group>
        <group group_id="P2">
          <title>WallFlex Biliary RX Uncovered Stent System</title>
          <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>WallFlex Biliary RX Fully Covered Stent System</title>
          <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
        </group>
        <group group_id="B2">
          <title>WallFlex Biliary RX Uncovered Stent System</title>
          <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</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="59"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="119"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.0" lower_limit="58.0" upper_limit="71.0"/>
                    <measurement group_id="B2" value="65.0" lower_limit="58.5" upper_limit="73.0"/>
                    <measurement group_id="B3" value="65" lower_limit="58" upper_limit="72"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.7" lower_limit="62.3" upper_limit="87"/>
                    <measurement group_id="B2" value="78.4" lower_limit="65.1" upper_limit="90.4"/>
                    <measurement group_id="B3" value="78" lower_limit="64.6" upper_limit="89.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gallbladder in Situ</title>
          <description>A count of participants with no prior history of cholecystectomy (gallbladder still in place).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Karnofsky Score (overall health status)</title>
          <description>100 Normal no complaints nor evidence of disease;90 Normal activity, minor signs/symptoms of disease;80 Normal activity w/effort, some sign/symptom of disease;70 Cares for self, unable to carry on normal activity/do active work;60 Requires occasional assistance, able to care for most personal needs;50 Requires considerable assistance &amp; frequent medical care;40 Disabled, requires special care/assistance;30 Severely disabled, hospitalization indicated, death not imminent;20 Very sick, hospitalization &amp; active support treatment necessary;10 Moribund, fatal processes progress rapidly;0 Dead</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90.0" lower_limit="80.0" upper_limit="100.0"/>
                    <measurement group_id="B2" value="80.0" lower_limit="80.0" upper_limit="90.0"/>
                    <measurement group_id="B3" value="90" lower_limit="80" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor Size</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.1" spread="1.4"/>
                    <measurement group_id="B2" value="2.9" spread="50.9"/>
                    <measurement group_id="B3" value="3.0" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor Stage</title>
          <description>Tumor, Node, Metastasis Cancer Staging System:&#xD;
Primary Tumor (T)1-4: Tumor size and extent; higher number indicates larger tumor and/or spread to nearby tissues Regional Lymph Node (N)0-3: N0 no regional lymph node involvement; 1-3 indicates number of regional lymph nodes involved and extent of involvement (higher number is more lymph node involvement) Distant Metastasis (M)0: No distant metastases</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>IA - T1 N0 M0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IB - T2 N0 M0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIA - T3 N0 M0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIB - T1 N1 M0; T2 N1 M0; T3 N1 M0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III - T4 Any N M0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants who underwent curative intent surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of participants not undergoing curative intent surgery&amp;followed to 1year post-stent placement</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="60"/>
                    <count group_id="B3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms</title>
        <description>Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.</description>
        <time_frame>From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)</time_frame>
        <population>Participant was eligible for primary endpoint analysis if participant did not undergo biliary reintervention from time of SEMS placement to CIS, or from time of SEMS placement to one year after SEMS placement (for participants not undergoing CIS).</population>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms</title>
          <description>Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.</description>
          <population>Participant was eligible for primary endpoint analysis if participant did not undergo biliary reintervention from time of SEMS placement to CIS, or from time of SEMS placement to one year after SEMS placement (for participants not undergoing CIS).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="43"/>
                  </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>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The prespecified non-inferiority margin was set at 20%. This was chosen to support a practical study size while still able to identify major differences if this were the case.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>Reported p-value of &lt;0.01 is calculated p-value. (p&lt;0.05 was considered significant)</p_value_desc>
            <method>Exact Non-inferiority</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure-related or Stent-related Serious Adverse Events</title>
        <description>Serious adverse events related to the stent placement procedure or to the stent</description>
        <time_frame>From stent placement procedure up to one year after stent placement procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure-related or Stent-related Serious Adverse Events</title>
          <description>Serious adverse events related to the stent placement procedure or to the stent</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="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="12"/>
                  </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>0.66</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Technical Success</title>
        <description>Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.</description>
        <time_frame>During the Stent Placement Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Success</title>
          <description>Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.</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="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention</title>
        <description>The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention</description>
        <time_frame>From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS</time_frame>
        <population>Of 59 participants in the Fully Covered arm, neoadjuvant therapy information was only provided for 55 participants. Of 60 participants in the Uncovered arm, neoadjuvant therapy information was only provided for 52 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention</title>
          <description>The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention</description>
          <population>Of 59 participants in the Fully Covered arm, neoadjuvant therapy information was only provided for 55 participants. Of 60 participants in the Uncovered arm, neoadjuvant therapy information was only provided for 52 participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Stent Migration</title>
        <description>The number of participants with stent migration</description>
        <time_frame>At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS</time_frame>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Stent Migration</title>
          <description>The number of participants with stent migration</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="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure</title>
        <description>The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.</description>
        <time_frame>At the time of curative intent surgery (CIS) (median 110 days to CIS)</time_frame>
        <population>Of 59 Participants in Fully Covered Arm, 24 underwent Curative Intent Surgery. Of 60 Participants in Uncovered Arm, 27 underwent Curative Intent Surgery.</population>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure</title>
          <description>The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.</description>
          <population>Of 59 Participants in Fully Covered Arm, 24 underwent Curative Intent Surgery. Of 60 Participants in Uncovered Arm, 27 underwent Curative Intent Surgery.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement</title>
        <description>For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.</description>
        <time_frame>From stent placement to one year after stent placement for participants not undergoing curative intent surgery</time_frame>
        <population>30 participants in the Fully Covered arm did not undergo curative intent surgery and were followed for one year. 32 participants in the Uncovered arm did not undergo curative intent surgery and were followed for one year.</population>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement</title>
          <description>For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.</description>
          <population>30 participants in the Fully Covered arm did not undergo curative intent surgery and were followed for one year. 32 participants in the Uncovered arm did not undergo curative intent surgery and were followed for one year.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Number of Participants With Tumor Ingrowth</title>
        <description>The number of participants with tumor ingrowth at any point during stent indwell.</description>
        <time_frame>Measured at any point during stent indwell - until curative intent surgery (CIS) (median 110 days to CIS) or one year post stent placement (for participants not underoing CIS)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Tumor Ingrowth</title>
          <description>The number of participants with tumor ingrowth at any point during stent indwell.</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="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Number of Participants With Acute Cholecystitis</title>
        <description>The number of participants with acute cholecystitis</description>
        <time_frame>From stent placement up to curative intent surgery (CIS) (median 110 days to CIS), or from stent placement up to one year post stent placement for participants not undergoing CIS</time_frame>
        <population>43/59 participants in Fully Covered Arm and 42/60 participants in Uncovered Arm had gallbladder in situ. Therefore, Acute Cholecystitis only analyzed in 43 participants in Fully Covered Arm and 42 participants in Uncovered Arm.</population>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Cholecystitis</title>
          <description>The number of participants with acute cholecystitis</description>
          <population>43/59 participants in Fully Covered Arm and 42/60 participants in Uncovered Arm had gallbladder in situ. Therefore, Acute Cholecystitis only analyzed in 43 participants in Fully Covered Arm and 42 participants in Uncovered Arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Mortality at One Year After Randomization</title>
        <description>The mortality at one year after randomization.</description>
        <time_frame>From randomization to one year after randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>WallFlex Biliary RX Fully Covered Stent System</title>
            <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
          <group group_id="O2">
            <title>WallFlex Biliary RX Uncovered Stent System</title>
            <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality at One Year After Randomization</title>
          <description>The mortality at one year after randomization.</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="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data collected from the time the participant signed the informed consent and was randomized to the study, to the time the participant exited the study (median of 344 days of follow-up).</time_frame>
      <desc>Reported on all treatment related Serious Adverse Events</desc>
      <group_list>
        <group group_id="E1">
          <title>WallFlex Biliary RX Fully Covered Stent System</title>
          <description>Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
        </group>
        <group group_id="E2">
          <title>WallFlex Biliary RX Uncovered Stent System</title>
          <description>Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).&#xD;
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System&#xD;
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>CBD Obstruction or Abnormal LFTs</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Liver Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
              </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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Lina Ginnetti, Clinical Endoscopy Director</name_or_title>
      <organization>Boston Scientific Corporation</organization>
      <phone>508-683-4512</phone>
      <email>lina.ginnetti@bsci.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238847
org study id: 90905950
secondary id: E7034
nct id: NCT02238847
lead sponsor: 
has dmc: No
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to
      Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary
      obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
time frame: From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)
description: Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.
measure: Procedure-related or Stent-related Serious Adverse Events
time frame: From stent placement procedure up to one year after stent placement procedure
description: Serious adverse events related to the stent placement procedure or to the stent
measure: Technical Success
time frame: During the Stent Placement Procedure
description: Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.
measure: Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
time frame: From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS
description: The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention
measure: Number of Participants With Stent Migration
time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS
description: The number of participants with stent migration
measure: Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure
time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS)
description: The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.
measure: For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
time frame: From stent placement to one year after stent placement for participants not undergoing curative intent surgery
description: For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.
arm group label: WallFlex Biliary RX Fully Covered Stent System
arm group type: Active Comparator
description: Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
arm group label: WallFlex Biliary RX Uncovered Stent System
arm group type: Active Comparator
description: Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
intervention type: Device
intervention name: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
description: Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
arm group label: WallFlex Biliary RX Fully Covered Stent System
arm group label: WallFlex Biliary RX Uncovered Stent System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yousuke Nakai, MD, PhD
role: Principal Investigator
affiliation: Tokyo University
last name: Dong-Wan Seo, MD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Canada
country: Italy
country: Japan
country: Korea, Republic of
country: United States
country: United Kingdom
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 