<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/NCT02992353</url>
  </required_header>
  <id_info>
    <org_study_id>Z161100000116044</org_study_id>
    <nct_id>NCT02992353</nct_id>
  </id_info>
  <brief_title>Single-port, Two-port Versus Three-port VATS on Non-small Cell Lung Cancer</brief_title>
  <official_title>Single-port Versus Two-port Versus Three-port Video Assisted Thoracoscopic Pulmonary Resection on Non-small Cell Lung Cancer: a Prospective Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In china, the incidence and death rate of lung cancer is 48.32 per 100 000 person-years and&#xD;
      39.27 per 100 000 person-years, respectively, the highest in malignant tumor. Surgical&#xD;
      operation is still main treatment means to resectable NSCLC. VATS pulmonary resection is&#xD;
      performed in clinical operation with the aim of decreasing postoperative complications&#xD;
      morbidity. The mechanisms may be due to minimize the inflammation reaction to surgical&#xD;
      injury. There are some trials regarding two-port VATS versus three-port VATS versus four-port&#xD;
      VATS or single-port VATS versus three-port VATS. However, there is no prospective randomised&#xD;
      controlled trial regarding Single-port versus two-port versus three-port video assisted&#xD;
      thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that single-port and&#xD;
      two-port VATS were feasible and safe through the trial, and we hope the results of our study&#xD;
      will provide a high level of clinical evidence for choosing the best operative approach in&#xD;
      VATS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: In china, the incidence and death rate of lung cancer is 48.32 per 100 000&#xD;
      person-years and 39.27 per 100 000 person-years, respectively, the highest in malignant&#xD;
      tumor. Surgical operation is still main treatment means to resectable NSCLC. VATS pulmonary&#xD;
      resection is performed in clinical operation with the aim of decreasing postoperative&#xD;
      complications morbidity. The mechanisms may be due to minimize the inflammation reaction to&#xD;
      surgical injury. There are some trials regarding two-port VATS versus three-port VATS versus&#xD;
      four-port VATS or single-port VATS versus three-port VATS. However, there is no prospective&#xD;
      randomised controlled trial regarding Single-port versus two-port versus three-port video&#xD;
      assisted thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that&#xD;
      single-port and two-port VATS were feasible and safe through the trial, and we hope the&#xD;
      results of our study will provide a high level of clinical evidence for choosing the best&#xD;
      operative approach in VATS.&#xD;
&#xD;
      Methods and analysis: this is a three years prospective randomised controlled trial, which&#xD;
      aims to attest the safety and feasibility of simple-port VATS and two-port VATS. Group A, B&#xD;
      and C receives single-port VATS, two-port VATS and three-port VATS pulmonary resection&#xD;
      respectively. The primary endpoint is postoperative recurrence rate. The secondary endpoints&#xD;
      include other postoperative complications morbidity , such as the number and location of&#xD;
      lymph nodes dissected、operation time, intraoperative volume of blood loss, hospital stays,&#xD;
      hospitalization expenses, quantity of using antalgica, change of pulmonary function. 70&#xD;
      patients are enrolled per group in three years, after adding 10% loss of the sample, 77&#xD;
      patients will be required for each group so a total of 231 patients will be enrolled into the&#xD;
      study in the end.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>Local recurrence</measure>
    <time_frame>2 years</time_frame>
    <description>two-year local recurrence rate after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative respiratory complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Systematic Classification of Morbidity and Mortality After Thoracic Surgery. Grade I, any complication without need for pharmacologic treatment or other intervention. Grade II, any complication that requires pharmacologic treatment or minor intervention only. Grade III , any complication that requires surgical, radiologic, endoscopic intervention, or multitherapy.&#xD;
Grade IV, any complication requiring intensive care unit management and life support.&#xD;
Grade V, any complication leading to the death of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymph node dissection</measure>
    <time_frame>Intraoperation</time_frame>
    <description>During the surgery, lymph node dissection were performed. The number of removed lymph-nodes were recorded according to the postoperative pathological diagnosis, and the stations of the lymph node were recorded according to the International Association for the Study of Lung Cancer (IASLC) Lymph Node Map.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>Intraoperation</time_frame>
    <description>blood loss during the surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">231</enrollment>
  <condition>Lung Neoplasm</condition>
  <arm_group>
    <arm_group_label>Three-port pulmonary resection surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated by traditional video assisted thoracoscopic three-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single-port or two-port surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated by minimally invasive video assisted thoracoscopic single-port or two-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Three-port pulmonary resection surgery</intervention_name>
    <description>Three-port pulmonary resection surgery</description>
    <arm_group_label>Three-port pulmonary resection surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-port or two-port surgery</intervention_name>
    <description>Single-port or two-port pulmonary resection surgery</description>
    <arm_group_label>Single-port or two-port surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 80 years;&#xD;
&#xD;
          -  cT1-3N0-1M0 diagnosed by chest CT or PET-CT before operation;&#xD;
&#xD;
          -  ECOG PS scores≤2;&#xD;
&#xD;
          -  The patients sign informed consents by themselves.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to tolerance of tracheal intubation and general anesthesia;&#xD;
&#xD;
          -  ECOG PS scores&gt;2;&#xD;
&#xD;
          -  Severe comorbidities including: Angina occurs in 3 months, uncontrolled hypertension,&#xD;
             Congestive heart failure, a history of myocardial infarction in 6 months before&#xD;
             admission, severe arrhythmia, severe liver, kidney or other metabolic diseases.&#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>Juwei Mu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Municipal Science &amp; Technology Commission</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juwei Mu, MD</last_name>
    <phone>8610-87788495</phone>
    <phone_ext>7140</phone_ext>
    <email>mujuwei@cicams.ac.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital of Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juwei Mu, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Ju-Wei Mu</investigator_full_name>
    <investigator_title>MD, PHD</investigator_title>
  </responsible_party>
  <keyword>VATS</keyword>
  <keyword>NSCLC</keyword>
  <keyword>recurrence rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT02992353
org study id: Z161100000116044
nct id: NCT02992353
lead sponsor: 
has dmc: Yes
In china, the incidence and death rate of lung cancer is 48.32 per 100 000 person-years and
      39.27 per 100 000 person-years, respectively, the highest in malignant tumor. Surgical
      operation is still main treatment means to resectable NSCLC. VATS pulmonary resection is
      performed in clinical operation with the aim of decreasing postoperative complications
      morbidity. The mechanisms may be due to minimize the inflammation reaction to surgical
      injury. There are some trials regarding two-port VATS versus three-port VATS versus four-port
      VATS or single-port VATS versus three-port VATS. However, there is no prospective randomised
      controlled trial regarding Single-port versus two-port versus three-port video assisted
      thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that single-port and
      two-port VATS were feasible and safe through the trial, and we hope the results of our study
      will provide a high level of clinical evidence for choosing the best operative approach in
      VATS.
Introduction: In china, the incidence and death rate of lung cancer is 48.32 per 100 000
      person-years and 39.27 per 100 000 person-years, respectively, the highest in malignant
      tumor. Surgical operation is still main treatment means to resectable NSCLC. VATS pulmonary
      resection is performed in clinical operation with the aim of decreasing postoperative
      complications morbidity. The mechanisms may be due to minimize the inflammation reaction to
      surgical injury. There are some trials regarding two-port VATS versus three-port VATS versus
      four-port VATS or single-port VATS versus three-port VATS. However, there is no prospective
      randomised controlled trial regarding Single-port versus two-port versus three-port video
      assisted thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that
      single-port and two-port VATS were feasible and safe through the trial, and we hope the
      results of our study will provide a high level of clinical evidence for choosing the best
      operative approach in VATS.

      Methods and analysis: this is a three years prospective randomised controlled trial, which
      aims to attest the safety and feasibility of simple-port VATS and two-port VATS. Group A, B
      and C receives single-port VATS, two-port VATS and three-port VATS pulmonary resection
      respectively. The primary endpoint is postoperative recurrence rate. The secondary endpoints
      include other postoperative complications morbidity , such as the number and location of
      lymph nodes dissected、operation time, intraoperative volume of blood loss, hospital stays,
      hospitalization expenses, quantity of using antalgica, change of pulmonary function. 70
      patients are enrolled per group in three years, after adding 10% loss of the sample, 77
      patients will be required for each group so a total of 231 patients will be enrolled into the
      study in the end.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local recurrence
time frame: 2 years
description: two-year local recurrence rate after surgery
measure: Postoperative respiratory complications
time frame: 30 days after surgery
description: Systematic Classification of Morbidity and Mortality After Thoracic Surgery. Grade I, any complication without need for pharmacologic treatment or other intervention. Grade II, any complication that requires pharmacologic treatment or minor intervention only. Grade III , any complication that requires surgical, radiologic, endoscopic intervention, or multitherapy.
Grade IV, any complication requiring intensive care unit management and life support.
Grade V, any complication leading to the death of the patient.
measure: Lymph node dissection
time frame: Intraoperation
description: During the surgery, lymph node dissection were performed. The number of removed lymph-nodes were recorded according to the postoperative pathological diagnosis, and the stations of the lymph node were recorded according to the International Association for the Study of Lung Cancer (IASLC) Lymph Node Map.
measure: Blood loss
time frame: Intraoperation
description: blood loss during the surgery
arm group label: Three-port pulmonary resection surgery
arm group type: Active Comparator
description: Treated by traditional video assisted thoracoscopic three-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.
arm group label: Single-port or two-port surgery
arm group type: Active Comparator
description: Treated by minimally invasive video assisted thoracoscopic single-port or two-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.
intervention type: Procedure
intervention name: Three-port pulmonary resection surgery
description: Three-port pulmonary resection surgery
arm group label: Three-port pulmonary resection surgery
intervention type: Procedure
intervention name: Single-port or two-port surgery
description: Single-port or two-port pulmonary resection surgery
arm group label: Single-port or two-port surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Juwei Mu, MD
role: Principal Investigator
affiliation: Beijing Municipal Science & Technology Commission
last name: Juwei Mu, MD
phone: 8610-87788495
phone ext: 7140
email: mujuwei@cicams.ac.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Ju-Wei Mu
investigator title: MD, PHD
mesh term: Lung Neoplasms
sharing ipd: Undecided