<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/NCT01661686</url>
  </required_header>
  <id_info>
    <org_study_id>COPAC</org_study_id>
    <nct_id>NCT01661686</nct_id>
  </id_info>
  <brief_title>Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures</brief_title>
  <acronym>COPAC</acronym>
  <official_title>A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation for Liver Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Foundation for Liver Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether fully covered or partially covered metal&#xD;
      stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary&#xD;
      outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a&#xD;
      stent or tumour related cause in a 6-month follow-up&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Number of Participants With Recurrent Dysphagia.</measure>
    <time_frame>From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.</time_frame>
    <description>This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Technical Success of SEMS Placement</measure>
    <time_frame>At stent placement (t=0)</time_frame>
    <description>Technical succes was defined as succesful deployment of the stent which bridges the stricture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score</measure>
    <time_frame>From stent placement until death or placement of second stent, assessed up to 6 months.</time_frame>
    <description>Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.&#xD;
Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants in Whom a Major Complication Has Occured</measure>
    <time_frame>From stent placement until death or placement of second stent, assessed up to 6 months</time_frame>
    <description>A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Survival After SEMS Placement</measure>
    <time_frame>From stent placement until death or placement of second stent</time_frame>
    <description>Survival from stent placement until death or placement of second stent</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Esophageal Cancer</condition>
  <condition>Esophageal Stenosis</condition>
  <arm_group>
    <arm_group_label>Insertion of a partially covered SEMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Insertion of a Fully covered SEMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Partially covered SEMS</intervention_name>
    <description>Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
    <arm_group_label>Insertion of a partially covered SEMS</arm_group_label>
    <other_name>WallFlex Partially covered esophageal stent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fully covered SEMS</intervention_name>
    <description>Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
    <arm_group_label>Insertion of a Fully covered SEMS</arm_group_label>
    <other_name>WallFlex Fully covered esophageal stent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malignant stricture of the esophagus or cardia&#xD;
&#xD;
          -  No curative treatment options available&#xD;
&#xD;
          -  Dysphagia grade of at least 2 (i.e. swallow semi-solid foods or less)&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with self-expandable metal stent for same condition&#xD;
&#xD;
          -  Evidence of tumor within 2 cm of the upper esophageal sphincter.&#xD;
&#xD;
          -  Presence of an esophago-tracheal or -bronchial fistula or both.&#xD;
&#xD;
          -  Not able to undergo upper endoscopy&#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>Marco J Bruno, M.D., Prof</last_name>
    <role>Study Director</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IJsselland Hospital</name>
      <address>
        <city>Capelle Aan Den IJssel</city>
        <state>Zuid Holland</state>
        <zip>2900 AR</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Fransiscus Gasthuis</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid Holland</state>
        <zip>3045 PM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ikazia Hospital</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid Holland</state>
        <zip>3083 AN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Hospital</name>
      <address>
        <city>Zwijndrecht</city>
        <state>Zuid Holland</state>
        <zip>3331 LZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <results_first_submitted>January 11, 2019</results_first_submitted>
  <results_first_submitted_qc>September 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 3, 2019</results_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Foundation for Liver Research</investigator_affiliation>
    <investigator_full_name>Manon Spaander</investigator_full_name>
    <investigator_title>M.D., PhD</investigator_title>
  </responsible_party>
  <keyword>esophageal cancer</keyword>
  <keyword>esophageal stenosis</keyword>
  <keyword>stent</keyword>
  <keyword>endoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Esophageal Stenosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Insertion of a Partially Covered SEMS</title>
          <description>Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
        </group>
        <group group_id="P2">
          <title>Insertion of a Fully Covered SEMS</title>
          <description>Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>did not receive allocated intervention</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.</population>
      <group_list>
        <group group_id="B1">
          <title>Insertion of a Partially Covered SEMS</title>
          <description>Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
        </group>
        <group group_id="B2">
          <title>Insertion of a Fully Covered SEMS</title>
          <description>Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</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="49"/>
            <count group_id="B2" value="48"/>
            <count group_id="B3" value="97"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.8" spread="11.4"/>
                    <measurement group_id="B2" value="69.2" spread="12.1"/>
                    <measurement group_id="B3" value="70.1" spread="11.8"/>
                  </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="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dysphagia score</title>
          <description>Dysphagia was scored according to the internationally used scoring system: score 0, able to consume a normal diet; score 1, dysphagia with certain solid foods; score 2, able to swallow semi-solid soft foods; score 3, able to swallow liquids only; score 4, complete dysphagia.&#xD;
Range 0-4, a higher score represents a worse outcome</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.8" spread="0.8"/>
                    <measurement group_id="B2" value="2.8" spread="0.7"/>
                    <measurement group_id="B3" value="2.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>WHO</title>
          <description>World Health Organization Performance Score&#xD;
0 Able to carry out all normal activity without restrictions.&#xD;
Restricted in physically strenuous activity but ambulatory and able to carry out light work.&#xD;
Ambulatory and capable of all self-care but unable to carry out any work; up and more than 50% of waking hours.&#xD;
Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.&#xD;
Completely disabled; cannot carry on any self-care; totally confined to bed or chair.&#xD;
Range 0-4, a higher score respresents a worse outcome</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.4" spread="0.8"/>
                    <measurement group_id="B2" value="1.1" spread="0.8"/>
                    <measurement group_id="B3" value="1.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Etiology/histology stricture</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Adenocarcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Squamous cell carcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extrinsic compression</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Presence of distant metastasis</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous chemotherapy</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous radiotherapy</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Location stricture</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Proximal esophagus</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mid esophagus</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Distal esophagus or cardia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of tumor</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.8" spread="3.1"/>
                    <measurement group_id="B2" value="7.6" spread="3.7"/>
                    <measurement group_id="B3" value="7.2" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of stricture</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.4" spread="2.6"/>
                    <measurement group_id="B2" value="6.0" spread="2.9"/>
                    <measurement group_id="B3" value="5.7" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Recurrent Dysphagia.</title>
        <description>This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.</description>
        <time_frame>From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.</time_frame>
        <population>One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.</population>
        <group_list>
          <group group_id="O1">
            <title>Insertion of a Partially Covered SEMS</title>
            <description>Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
          <group group_id="O2">
            <title>Insertion of a Fully Covered SEMS</title>
            <description>Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Recurrent Dysphagia.</title>
          <description>This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.</description>
          <population>One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.</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="49"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Technical Success of SEMS Placement</title>
        <description>Technical succes was defined as succesful deployment of the stent which bridges the stricture</description>
        <time_frame>At stent placement (t=0)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insertion of a Partially Covered SEMS</title>
            <description>Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
          <group group_id="O2">
            <title>Insertion of a Fully Covered SEMS</title>
            <description>Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Technical Success of SEMS Placement</title>
          <description>Technical succes was defined as succesful deployment of the stent which bridges 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="49"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score</title>
        <description>Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.&#xD;
Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months</description>
        <time_frame>From stent placement until death or placement of second stent, assessed up to 6 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insertion of a Partially Covered SEMS</title>
            <description>Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
          <group group_id="O2">
            <title>Insertion of a Fully Covered SEMS</title>
            <description>Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score</title>
          <description>Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.&#xD;
Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months</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="49"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants in Whom a Major Complication Has Occured</title>
        <description>A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.</description>
        <time_frame>From stent placement until death or placement of second stent, assessed up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insertion of a Partially Covered SEMS</title>
            <description>Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
          <group group_id="O2">
            <title>Insertion of a Fully Covered SEMS</title>
            <description>Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants in Whom a Major Complication Has Occured</title>
          <description>A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.</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="49"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Survival After SEMS Placement</title>
        <description>Survival from stent placement until death or placement of second stent</description>
        <time_frame>From stent placement until death or placement of second stent</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Insertion of a Partially Covered SEMS</title>
            <description>Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
          <group group_id="O2">
            <title>Insertion of a Fully Covered SEMS</title>
            <description>Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
          </group>
        </group_list>
        <measure>
          <title>Median Survival After SEMS Placement</title>
          <description>Survival from stent placement until death or placement of second stent</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="5" upper_limit="656"/>
                    <measurement group_id="O2" value="61" lower_limit="4" upper_limit="596"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Insertion of a Partially Covered SEMS</title>
          <description>Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
        </group>
        <group group_id="E2">
          <title>Insertion of a Fully Covered SEMS</title>
          <description>Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Severe pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>mediastinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Fistula</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>pressure ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>spondyloscitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>stridor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Mild pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="48"/>
              </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>Dr. V.M.C.W. Spaander</name_or_title>
      <organization>Erasmus University Medical Center</organization>
      <phone>0031 10 703 5643</phone>
      <email>v.spaander@erasmusmc.nl</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/NCT01661686
org study id: COPAC
nct id: NCT01661686
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether fully covered or partially covered metal
      stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary
      outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a
      stent or tumour related cause in a 6-month follow-up
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Recurrent Dysphagia.
time frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
description: This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.
measure: Number of Participants With Technical Success of SEMS Placement
time frame: At stent placement (t=0)
description: Technical succes was defined as succesful deployment of the stent which bridges the stricture
measure: Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score
time frame: From stent placement until death or placement of second stent, assessed up to 6 months.
description: Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.
Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months
measure: Number of Participants in Whom a Major Complication Has Occured
time frame: From stent placement until death or placement of second stent, assessed up to 6 months
description: A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.
measure: Median Survival After SEMS Placement
time frame: From stent placement until death or placement of second stent
description: Survival from stent placement until death or placement of second stent
arm group label: Insertion of a partially covered SEMS
arm group type: Active Comparator
arm group label: Insertion of a Fully covered SEMS
arm group type: Active Comparator
intervention type: Device
intervention name: Partially covered SEMS
description: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
arm group label: Insertion of a partially covered SEMS
other name: WallFlex Partially covered esophageal stent
intervention type: Device
intervention name: Fully covered SEMS
description: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
arm group label: Insertion of a Fully covered SEMS
other name: WallFlex Fully covered esophageal stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marco J Bruno, M.D., Prof
role: Study Director
affiliation: Erasmus Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Foundation for Liver Research
investigator full name: Manon Spaander
investigator title: M.D., PhD
mesh term: Esophageal Neoplasms
mesh term: Esophageal Stenosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 