<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/NCT03227380</url>
  </required_header>
  <id_info>
    <org_study_id>THO-2016-01</org_study_id>
    <nct_id>NCT03227380</nct_id>
  </id_info>
  <brief_title>Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy</brief_title>
  <official_title>Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Mutualiste Montsouris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Mutualiste Montsouris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine whether stapling adversely affects the pulmonary&#xD;
      parenchyma and the vascularisation of the adjacent segments. The aim of our work is to&#xD;
      explore by thoracic densitometry with contrast the spared segments after stapling of the&#xD;
      intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the&#xD;
      investigator will assess venous drainage and the arterial vascularisation of the remaining&#xD;
      segments, possible modifications of the adjacent parenchyma and whether there is a defect of&#xD;
      pleuro-pulmonary adhesion (residual pneumothorax).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scheduled anatomical segmentectomies are increasingly popular, due to the development of&#xD;
      minimally invasive techniques, the increased incidence of early-stage tumours, and the&#xD;
      possibility of caring for patients with compromised health and/or limited respiratory&#xD;
      function without compromising the oncological outcome, compared to current alternatives such&#xD;
      as stereotactic ablative radiotherapy (1).&#xD;
&#xD;
      One of the challenges in the development of the thoracoscopic segmentectomy technique we have&#xD;
      published (2-5) is the orientation (6-7) and the division of the intersegmental plane, by&#xD;
      contrast to segmentectomy by thoracotomy where this is helped by palpation and the manual&#xD;
      traction which can be used on the segment, along the intersegmental vein. The most commonly&#xD;
      used technique to separate two adjacent segments remains stapling, despite its high cost and&#xD;
      sometimes giving a less anatomical section, with a risk to encroach on the intersegmental&#xD;
      vein. Moreover, there can be a partial plicator of the spared segment(s) which could in&#xD;
      theory make them less functional.&#xD;
&#xD;
      We have however shown that the postoperative morbidity and mortality rates were much lower&#xD;
      than that of patients who had a thoracotomy, dropping from 42% for thoracotomies to 16% for&#xD;
      thoracoscopies, the surgical approach being an independent predictive factor for&#xD;
      postoperative complications (8).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 20, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>patients undergo anatomic segmentectomy by video-assisted thoracoscopic surgery (VATS)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The measure of the remaining segments after stapling the intersegmental plane by injected CT scan</measure>
    <time_frame>3 or 6 months after surgery</time_frame>
    <description>The aim of investigators work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, from 3 to 6 months post-surgery. The investigators will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).&#xD;
The radiological evaluation criteria will be:&#xD;
Presence and quantification of a defect in pulmonary expansion (residual pneumothorax)&#xD;
Abnormal venous and arterial vascularisation of the remaining segments&#xD;
Defect of the pulmonary parenchyma in contact with the staples line (atelectasis, vascularisation defect)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Video-assisted Thoracoscopic Surgery (VATS)</condition>
  <condition>Segmentectomy</condition>
  <arm_group>
    <arm_group_label>radiological evaluation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>thoracic densitometry with contrast</intervention_name>
    <description>injected CT scan at 3 or 6 months after segmentectomy VATS</description>
    <arm_group_label>radiological evaluation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolment in the study will be offered to all patients having undergone a programmed&#xD;
             scheduled video-assisted thoracoscopic segmentectomy, whatever the aetiology.&#xD;
&#xD;
          -  Men or women aged 18 years or greater&#xD;
&#xD;
          -  Absence of severe hepatic insufficiency&#xD;
&#xD;
          -  signed and dated informed consent&#xD;
&#xD;
          -  candidate for segmentectomy&#xD;
&#xD;
          -  Registration in a national healthcare system.&#xD;
&#xD;
          -  Women of child-bearing age using effective oral or barrier contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Proven intolerance to iodinated contrast agents&#xD;
&#xD;
          -  Know allergy or non-controlled asthma - pregnancy&#xD;
&#xD;
          -  Severe hepatic insufficiency (creatinine clearance &lt; 30ml/min, by Cockroft's method)&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patients under trusteeship or curators&#xD;
&#xD;
          -  Diabetic patients or patients receiving oral antidiabetic medication&#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_contact>
    <last_name>Agathe SEGUIN-GIVELET, MD</last_name>
    <phone>0156616240</phone>
    <email>agathe.seguin-givelet@imm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut Mutualiste montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut mutualiste montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle SAURET</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03227380
org study id: THO-2016-01
nct id: NCT03227380
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to determine whether stapling adversely affects the pulmonary
      parenchyma and the vascularisation of the adjacent segments. The aim of our work is to
      explore by thoracic densitometry with contrast the spared segments after stapling of the
      intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the
      investigator will assess venous drainage and the arterial vascularisation of the remaining
      segments, possible modifications of the adjacent parenchyma and whether there is a defect of
      pleuro-pulmonary adhesion (residual pneumothorax).
Scheduled anatomical segmentectomies are increasingly popular, due to the development of
      minimally invasive techniques, the increased incidence of early-stage tumours, and the
      possibility of caring for patients with compromised health and/or limited respiratory
      function without compromising the oncological outcome, compared to current alternatives such
      as stereotactic ablative radiotherapy (1).

      One of the challenges in the development of the thoracoscopic segmentectomy technique we have
      published (2-5) is the orientation (6-7) and the division of the intersegmental plane, by
      contrast to segmentectomy by thoracotomy where this is helped by palpation and the manual
      traction which can be used on the segment, along the intersegmental vein. The most commonly
      used technique to separate two adjacent segments remains stapling, despite its high cost and
      sometimes giving a less anatomical section, with a risk to encroach on the intersegmental
      vein. Moreover, there can be a partial plicator of the spared segment(s) which could in
      theory make them less functional.

      We have however shown that the postoperative morbidity and mortality rates were much lower
      than that of patients who had a thoracotomy, dropping from 42% for thoracotomies to 16% for
      thoracoscopies, the surgical approach being an independent predictive factor for
      postoperative complications (8).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: patients undergo anatomic segmentectomy by video-assisted thoracoscopic surgery (VATS)
primary purpose: Other
masking: None (Open Label)
measure: The measure of the remaining segments after stapling the intersegmental plane by injected CT scan
time frame: 3 or 6 months after surgery
description: The aim of investigators work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, from 3 to 6 months post-surgery. The investigators will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).
The radiological evaluation criteria will be:
Presence and quantification of a defect in pulmonary expansion (residual pneumothorax)
Abnormal venous and arterial vascularisation of the remaining segments
Defect of the pulmonary parenchyma in contact with the staples line (atelectasis, vascularisation defect)
arm group label: radiological evaluation
arm group type: Other
description: to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy
intervention type: Other
intervention name: thoracic densitometry with contrast
description: injected CT scan at 3 or 6 months after segmentectomy VATS
arm group label: radiological evaluation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Agathe SEGUIN-GIVELET, MD
phone: 0156616240
email: agathe.seguin-givelet@imm.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided