xml: <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/NCT06015399</url>
    </required_header>
    <id_info>
      <org_study_id>LYF2023098</org_study_id>
      <nct_id>NCT06015399</nct_id>
    </id_info>
    <brief_title>Methods of Establishing Intersegmental Plane in Segmentectomy</brief_title>
    <official_title>Methods of Establishing Intersegmental Plane in Segmentectomy: a Prospective Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Xiangya Hospital of Central South University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Xiangya Hospital of Central South University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to perform a prospective, single-center, randomized controlled study&#xD;
        to explore whether closed insufflation technique is not inferior to dilatation and collapse&#xD;
        technique in segmentectomy, and to provide a new option for establishing intersegmental plane&#xD;
        in segmentectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, prospective, randomized controlled study. A total of 200 subjects&#xD;
        undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are&#xD;
        randomly divided into closed insufflation group or dilatation and collapse group using a&#xD;
        random number table generated by the computer, with 100 cases in each group. Intersegmental&#xD;
        plane resolution grading, perioperative complications, operative time, intraoperative blood&#xD;
        loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery&#xD;
        will be extracted and compared between the groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intersegmental plane clarity grading</measure>
      <time_frame>intraoperatively</time_frame>
      <description>Intersegmental plane clarity will be graded as followed: G1: partial collapse of targeted parenchymal tissue, G2: partial dilatation of non-targeted adjacent tissue, G3: dilatation of targeted tissue and unclearness of intersegmental plane, G4: entire dilatation of targeted tissue and clearness of intersegmental plane.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Surgical complications</measure>
      <time_frame>Up to 3 months</time_frame>
      <description>Surgical complications will be assessed according to the Society of Thoracic Surgeons database criteria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Operative time required for segmentectomy</measure>
      <time_frame>From the dissection of segmental structures to finish of segementectomy</time_frame>
      <description>Operative time required for segmentectomy will be measured as the total minutes from initiation to completion of segmentectomy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pulmonary function 3 months and 1 year after surgery</measure>
      <time_frame>Up to 1 year</time_frame>
      <description>Pulmonary function includes ventilation and diffusion function. Pulmonary function will be measured at two time points including 3 months and 1 year after surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intraoperative blood loss</measure>
      <time_frame>Intraoperatively</time_frame>
      <description>Intraoperative blood loss will be measured as the total volume of blood loss during the operation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative hospital stay</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>Postoperative hospital stay will be measured as the number of days between surgery and discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days of chest tube placement</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>Days of chest tube placement will be measured as the number of days between surgery and chest tube pull-out.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety margin</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>Minimum distance between nodule and every margin can be measured preoperatively by 3D reconstruction tool and intraoperatively by ruler after the targetd segment has been resected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of targeted parenchymal tissue</measure>
      <time_frame>Up to 3 days</time_frame>
      <description>Volume of targeted parenchymal tissue will be calculated by 3D reconstruction tool.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Closed insufflation technique group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Closed insufflation technique is characterized by ligation in the proximal portion of targeted bronchus and gas injection in the distal portion. Closed insufflation technique group includes patients undergoing segmentectomy using closed insufflation technique.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dilatation and collapse technique</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Dilatation and collapse technique is characterized by pure oxygen dilatation and subsequent collapse after the division of targeted bronchus. Dilatation and collapse technique group includes patients undergoing segmentectomy using Dilatation and collapse technique.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Implementation of closed insufflation technique during segmentectomy</intervention_name>
      <description>After the identification the targeted segmental bronchus during the operation,ligating the proximal end of the targeted bronchus. Put the vessel separation forceps in the distal bronchial space to avoid the accidental damage of the vessels. Use a 50ml syringe to inject air into the distal bronchus (about 100ml is expected) until the intersegmental plane is satisfactory. Divide the target bronchus using the cutting and closing device.</description>
      <arm_group_label>Closed insufflation technique group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Implementation of dilatation and collapse technique during segmentectomy</intervention_name>
      <description>Divide the target bronchus using the cutting and closing device. Ask the anesthesiologist to inflate the lung completely from pure oxygen to the affected side and then change to single lung ventilation. Wait for the intersegmental plane to appear(usually about 15 minutes).</description>
      <arm_group_label>Dilatation and collapse technique</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients voluntarily join and sign a written informed consent;&#xD;
  &#xD;
            2. The age of the subjects is 18-75 years old, regardless of gender;&#xD;
  &#xD;
            3. The ECOG PS was 0 or 1;&#xD;
  &#xD;
            4. Three-dimensional visualization was performed before surgery, and the surgeon judged&#xD;
               that the tumor could be completely removed by segmentectomy, and surgical margin was&#xD;
               expected to be greater than 2cm or the maximum diameter of the nodule;&#xD;
  &#xD;
            5. Thin-slice CT suggests any of the following: ① The diameter of pulmonary nodules is&#xD;
               2-3cm and the consolidation-tumor ratio (CTR) is less than 0.25; ② Pulmonary nodule&#xD;
               diameter ≤2cm and 0.25 &lt; CTR &lt; 0.5; ③ Non-peripheral pulmonary nodule diameter ≤2cm&#xD;
               and CTR≤0.25;&#xD;
  &#xD;
            6. cN0 and no distant metastasis;&#xD;
  &#xD;
            7. Intraoperative freezing examination or postoperative paraffin examination suggest&#xD;
               early lung adenocarcinoma;&#xD;
  &#xD;
            8. Intraoperative freezing disease of station 12 lymph nodes showed no cancer metastasis;&#xD;
  &#xD;
            9. Preoperative anesthesia risk assessment: American Society of Anesthesiologists (ASA)&#xD;
               Level I-III;&#xD;
  &#xD;
           10. Has no history of lung resection;&#xD;
  &#xD;
           11. Has not received anti-tumor therapy such as radiotherapy, chemotherapy, targeted&#xD;
               therapy and immunotherapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The subject did not understand the study protocol, did not cooperate or refused to&#xD;
               sign the informed consent;&#xD;
  &#xD;
            2. The subject has a history of malignant tumor or has previously received anti-tumor&#xD;
               therapy;&#xD;
  &#xD;
            3. 3D visualization was not received before surgery;&#xD;
  &#xD;
            4. The surgeon judged that segmentectomy could not ensure complete resection of the&#xD;
               tumor;&#xD;
  &#xD;
            5. has a history of lung resection, or chest trauma or surgery on the affected side of&#xD;
               chest cavity;&#xD;
  &#xD;
            6. Extensive intraoperative dense thoracic adhesion;&#xD;
  &#xD;
            7. Conversion to thoracotomy;&#xD;
  &#xD;
            8. Intraoperative frozen examination of intrapulmonary lymph nodes indicated cancer&#xD;
               metastasis;&#xD;
  &#xD;
            9. Pulmonary nodules are located in the right middle lung;&#xD;
  &#xD;
           10. Suffered from chronic bronchitis, emphysema, asthma and other chronic lung diseases;&#xD;
  &#xD;
           11. Other conditions unsuitable for inclusion in this study deemed by the researcher.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yan Hu, M.D., Ph.D.</last_name>
      <phone>+8685296122</phone>
      <email>yanhu@csu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410011</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Second Xiangya Hospital of Central South University</investigator_affiliation>
      <investigator_full_name>Liu Wenliang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>segmentectomy</keyword>
    <keyword>intersegmental plane</keyword>
    <keyword>closed insufflation technique</keyword>
    <keyword>dilatation and collapse technique</keyword>
    <keyword>randomized controlled study</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015399
  org study id: LYF2023098
  nct id: NCT06015399
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to perform a prospective, single-center, randomized controlled study
        to explore whether closed insufflation technique is not inferior to dilatation and collapse
        technique in segmentectomy, and to provide a new option for establishing intersegmental plane
        in segmentectomy.
  This is a single-center, prospective, randomized controlled study. A total of 200 subjects
        undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are
        randomly divided into closed insufflation group or dilatation and collapse group using a
        random number table generated by the computer, with 100 cases in each group. Intersegmental
        plane resolution grading, perioperative complications, operative time, intraoperative blood
        loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery
        will be extracted and compared between the groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Intersegmental plane clarity grading
  time frame: intraoperatively
  description: Intersegmental plane clarity will be graded as followed: G1: partial collapse of targeted parenchymal tissue, G2: partial dilatation of non-targeted adjacent tissue, G3: dilatation of targeted tissue and unclearness of intersegmental plane, G4: entire dilatation of targeted tissue and clearness of intersegmental plane.
  measure: Surgical complications
  time frame: Up to 3 months
  description: Surgical complications will be assessed according to the Society of Thoracic Surgeons database criteria.
  measure: Operative time required for segmentectomy
  time frame: From the dissection of segmental structures to finish of segementectomy
  description: Operative time required for segmentectomy will be measured as the total minutes from initiation to completion of segmentectomy.
  measure: Pulmonary function 3 months and 1 year after surgery
  time frame: Up to 1 year
  description: Pulmonary function includes ventilation and diffusion function. Pulmonary function will be measured at two time points including 3 months and 1 year after surgery.
  measure: Intraoperative blood loss
  time frame: Intraoperatively
  description: Intraoperative blood loss will be measured as the total volume of blood loss during the operation.
  measure: Postoperative hospital stay
  time frame: Up to 2 weeks
  description: Postoperative hospital stay will be measured as the number of days between surgery and discharge.
  measure: Days of chest tube placement
  time frame: Up to 2 weeks
  description: Days of chest tube placement will be measured as the number of days between surgery and chest tube pull-out.
  measure: Safety margin
  time frame: Up to 1 week
  description: Minimum distance between nodule and every margin can be measured preoperatively by 3D reconstruction tool and intraoperatively by ruler after the targetd segment has been resected.
  measure: Volume of targeted parenchymal tissue
  time frame: Up to 3 days
  description: Volume of targeted parenchymal tissue will be calculated by 3D reconstruction tool.
  arm group label: Closed insufflation technique group
  arm group type: Experimental
  description: Closed insufflation technique is characterized by ligation in the proximal portion of targeted bronchus and gas injection in the distal portion. Closed insufflation technique group includes patients undergoing segmentectomy using closed insufflation technique.
  arm group label: Dilatation and collapse technique
  arm group type: Active Comparator
  description: Dilatation and collapse technique is characterized by pure oxygen dilatation and subsequent collapse after the division of targeted bronchus. Dilatation and collapse technique group includes patients undergoing segmentectomy using Dilatation and collapse technique.
  intervention type: Procedure
  intervention name: Implementation of closed insufflation technique during segmentectomy
  description: After the identification the targeted segmental bronchus during the operation,ligating the proximal end of the targeted bronchus. Put the vessel separation forceps in the distal bronchial space to avoid the accidental damage of the vessels. Use a 50ml syringe to inject air into the distal bronchus (about 100ml is expected) until the intersegmental plane is satisfactory. Divide the target bronchus using the cutting and closing device.
  arm group label: Closed insufflation technique group
  intervention type: Procedure
  intervention name: Implementation of dilatation and collapse technique during segmentectomy
  description: Divide the target bronchus using the cutting and closing device. Ask the anesthesiologist to inflate the lung completely from pure oxygen to the affected side and then change to single lung ventilation. Wait for the intersegmental plane to appear(usually about 15 minutes).
  arm group label: Dilatation and collapse technique
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Yan Hu, M.D., Ph.D.
  phone: +8685296122
  email: yanhu@csu.edu.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Second Xiangya Hospital of Central South University
  investigator full name: Liu Wenliang
  investigator title: Professor