<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/NCT02207478</url>
  </required_header>
  <id_info>
    <org_study_id>SHCHE201401</org_study_id>
    <nct_id>NCT02207478</nct_id>
  </id_info>
  <brief_title>ENB-GS-TBLB for the Diagnosis of PPLs</brief_title>
  <official_title>Diagnostic Value of Electromagnetic Navigation Bronchoscopy With a Guide Sheath for Peripheral Pulmonary Lesions : a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Chest Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of electromagnetic&#xD;
      navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary&#xD;
      lesions (PPLs) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and&#xD;
      bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath&#xD;
      (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic&#xD;
      fluoroscopy.The study is designed as a two-center prospective randomized controlled trial.&#xD;
      The participating centers are Department of pulmonary medicine and endoscope department,&#xD;
      Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of&#xD;
      pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University,&#xD;
      China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray&#xD;
      group.Each subject will be randomized to each group.The study is expected to enroll 60&#xD;
      patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB</measure>
    <time_frame>Up to half year</time_frame>
    <description>The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone</measure>
    <time_frame>Up to half year</time_frame>
    <description>Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>ENB-GS-TBLB-X-ray Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GS-TBLB-X-ray group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ENB</intervention_name>
    <description>ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.</description>
    <arm_group_label>ENB-GS-TBLB-X-ray Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>GS-TBLB-X-ray</intervention_name>
    <description>A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
    <arm_group_label>ENB-GS-TBLB-X-ray Group</arm_group_label>
    <arm_group_label>GS-TBLB-X-ray group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. clinical and imaging characteristics suggestive of maligancy&#xD;
&#xD;
          2. CT scan appearance of the PPLs showed the longest diameter was more than 1 cm and&#xD;
             solid lesions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The lesion is close to the pleural membrane&#xD;
&#xD;
          2. Refusal of participation&#xD;
&#xD;
          3. Severe cardiopulmonary dysfunction and other indications that can't receive&#xD;
             bronchoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiayuan Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Chest Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. Epub 2014 Jan 3.</citation>
    <PMID>24401166</PMID>
  </reference>
  <reference>
    <citation>Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000 Apr;117(4):1049-54. doi: 10.1378/chest.117.4.1049.</citation>
    <PMID>10767238</PMID>
  </reference>
  <reference>
    <citation>Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.</citation>
    <PMID>21980059</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>September 23, 2015</results_first_submitted>
  <results_first_submitted_qc>October 28, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 30, 2015</results_first_posted>
  <last_update_submitted>October 28, 2015</last_update_submitted>
  <last_update_submitted_qc>October 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Jiayuan Sun</investigator_full_name>
    <investigator_title>Director, Endoscope Center, Shanghai Chest Hospita</investigator_title>
  </responsible_party>
  <keyword>Electromagnetic navigation bronchoscopy with a guide sheath</keyword>
  <keyword>Transbronchial lung biopsy</keyword>
  <keyword>Peripheral lung lesions</keyword>
  <keyword>Solitary pulmonary nodule</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ENB-GS-TBLB-X-ray Group</title>
          <description>The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System.&#xD;
ENB: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
        </group>
        <group group_id="P2">
          <title>GS-TBLB-X-ray Group</title>
          <description>The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ENB-GS-TBLB-X-ray Group</title>
          <description>The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
        </group>
        <group group_id="B2">
          <title>GS-TBLB-X-ray Group</title>
          <description>The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</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="39"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="80"/>
          </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="61.28" spread="7.61"/>
                    <measurement group_id="B2" value="59.32" spread="9.57"/>
                    <measurement group_id="B3" value="60.28" spread="8.67"/>
                  </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="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>lesion size(long axis)</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.7" spread="11"/>
                    <measurement group_id="B2" value="33.07" spread="13.8"/>
                    <measurement group_id="B3" value="31.39" spread="12.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>lesion size(short axis)</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.64" spread="10.42"/>
                    <measurement group_id="B2" value="22.28" spread="10.66"/>
                    <measurement group_id="B3" value="21.96" spread="10.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>lesion location</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Upper Lobes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Middle Lobes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lower lobes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>distance from the lesion to the pleural</title>
          <description>distance of the nodule to the pleural surface</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.53" spread="14.79"/>
                    <measurement group_id="B2" value="20.99" spread="16.08"/>
                    <measurement group_id="B3" value="18.19" spread="15.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>bronchus sign</title>
          <description>The bronchus sign on CT represents the presence of a bronchus leading directly to a peripheral pulmonary lesion.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB</title>
        <description>The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.</description>
        <time_frame>Up to half year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENB-GS-TBLB-X-ray Group</title>
            <description>The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
          </group>
          <group group_id="O2">
            <title>GS-TBLB-X-ray Group</title>
            <description>The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
          </group>
        </group_list>
        <measure>
          <title>The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB</title>
          <description>The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diagnosed by TBLB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Diagnosed by TBLB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="16"/>
                  </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 or Other</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone</title>
        <description>Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.</description>
        <time_frame>Up to half year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ENB-GS-TBLB-X-ray Group</title>
            <description>The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
          </group>
          <group group_id="O2">
            <title>GS-TBLB-X-ray Group</title>
            <description>The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
          </group>
        </group_list>
        <measure>
          <title>The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone</title>
          <description>Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total procedure time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1053.6" spread="408.6"/>
                    <measurement group_id="O2" value="1056.6" spread="387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total X-ray time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156.56" spread="94.03"/>
                    <measurement group_id="O2" value="142.27" spread="111.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Duration time for finding lesion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.74" spread="128.80"/>
                    <measurement group_id="O2" value="224.98" spread="119.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>X-ray time for finding lesion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.21" spread="7.79"/>
                    <measurement group_id="O2" value="38.88" spread="39.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Total procedure time</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.843</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Total X-ray time</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.233</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Duration time for finding lesions</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>X-ray time for finding lesions</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ENB-GS-TBLB-X-ray Group</title>
          <description>The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
        </group>
        <group group_id="E2">
          <title>GS-TBLB-X-ray Group</title>
          <description>The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.&#xD;
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </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>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. Jiayuan Sun</name_or_title>
      <organization>Shanghai Chest hospital</organization>
      <phone>+86 18017321598</phone>
      <email>jysun1976@163.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/NCT02207478
org study id: SHCHE201401
nct id: NCT02207478
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy and safety of electromagnetic
      navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary
      lesions (PPLs) .
The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and
      bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath
      (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic
      fluoroscopy.The study is designed as a two-center prospective randomized controlled trial.
      The participating centers are Department of pulmonary medicine and endoscope department,
      Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of
      pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University,
      China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray
      group.Each subject will be randomized to each group.The study is expected to enroll 60
      patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
time frame: Up to half year
description: The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.
measure: The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone
time frame: Up to half year
description: Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.
arm group label: ENB-GS-TBLB-X-ray Group
arm group type: Experimental
description: The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
arm group label: GS-TBLB-X-ray group
arm group type: Active Comparator
description: The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
intervention type: Procedure
intervention name: ENB
description: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.
arm group label: ENB-GS-TBLB-X-ray Group
intervention type: Procedure
intervention name: GS-TBLB-X-ray
description: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
arm group label: ENB-GS-TBLB-X-ray Group
arm group label: GS-TBLB-X-ray group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jiayuan Sun, MD
role: Principal Investigator
affiliation: Shanghai Chest Hospital
facility: 
country: China
citation: Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. Epub 2014 Jan 3.
PMID: 24401166
citation: Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000 Apr;117(4):1049-54. doi: 10.1378/chest.117.4.1049.
PMID: 10767238
citation: Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.
PMID: 21980059
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Jiayuan Sun
investigator title: Director, Endoscope Center, Shanghai Chest Hospita
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 