<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/NCT03826862</url>
  </required_header>
  <id_info>
    <org_study_id>LLND-2018</org_study_id>
    <nct_id>NCT03826862</nct_id>
  </id_info>
  <brief_title>Lateral Lymph Node Dissection for Middle-low Rectal Cancer</brief_title>
  <official_title>Prospective Study on Image-guided Internal Iliac Vessels Dissection and Node-for-node for Selected Lateral Lymph Node Dissection in Middles-low Rectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziqiang Wang,MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>No</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 investigators will perform CT three-dimension reconstruction for middle-low rectal cancer&#xD;
      patients who have enlarged lateral lymph nodes to recognize the variance of pelvic vessels,&#xD;
      by which to help reduce operative time and blood loss, localize the lateral lymph nodes,&#xD;
      improve the lymph node harvested and positive rate. Besides, The investigators will label the&#xD;
      vessels near the interested node to achieve node-by-node for further investigation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CT three-dimensional reconstruction was performed for middle-low patients who had enlarged&#xD;
      lateral lymph node before surgery. The main purpose is to recognize the track and variance of&#xD;
      pelvic and iliac blood vessels. The investigators want to explore whether this method can&#xD;
      help reduce operative time, unexpected injuries and blood loss, and The investigators also&#xD;
      want to study whether it can help improve the lymph node harvested and positive rate during&#xD;
      lateral lymph node dissection. Besides, The investigators want to perform node-by-node for&#xD;
      enlarged lateral lymph node and CT three-dimensional reconstruction can help the&#xD;
      investigators to localize and label the interested lymph node during operation. After&#xD;
      node-by-node, The investigators can explore the accuracy of radiologists' and surgeons'&#xD;
      judgement for lateral lymph node metastasis, and The investigators also want explore the best&#xD;
      cut-off value of shorter diameter to predict lateral lymph node metastasis. Besides, The&#xD;
      investigators want to perform texture analysis by combination radiology and pathology to find&#xD;
      some useful parameters to predict lateral lymph node metastasis.&#xD;
&#xD;
      The investigators also want to explore the feasibility of dissecting the unilateral visceral&#xD;
      branch of internal iliac vessels when performing lateral lymph node dissection.&#xD;
&#xD;
      The investigators will have a close follow-up for patients who have enlarged lateral lymph&#xD;
      node but do not meet the criteria for lateral lymph node dissection. CT three-dimensional&#xD;
      reconstruction can help The investigators recognize which parts' lateral lymph nodes have&#xD;
      more potential possibility to metastasis and recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This group with intervention will be compared previous group without intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>operative time</measure>
    <time_frame>2 year</time_frame>
    <description>including total operative time and that for lateral lymph node</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood loss</measure>
    <time_frame>2 year</time_frame>
    <description>intraoperative blood loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lateral lymph node harvested</measure>
    <time_frame>2 year</time_frame>
    <description>lateral lymph node harvested</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of judgement for lateral lymph node metastasis</measure>
    <time_frame>2 year</time_frame>
    <description>including radiologists' and surgeons' accuracy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cut-off value of shorter diameter</measure>
    <time_frame>2 year</time_frame>
    <description>The best cut-off value of shorter diameter for lateral lymph node dissection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>vessels variances</measure>
    <time_frame>October 1. 2018-December 31.2020</time_frame>
    <description>The blood vessels variance of internal iliac vessels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative complication</measure>
    <time_frame>2 year</time_frame>
    <description>including urinary and sexual function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>local recurrence rate</measure>
    <time_frame>3 year</time_frame>
    <description>local recurrence rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>3 year</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease-free survival</measure>
    <time_frame>3 year</time_frame>
    <description>disease-free survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive CT three-dimensional reconstruction before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All patients did not receive CT three-dimensional before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>CT three-dimensional reconstruction</intervention_name>
    <description>All patients will receive CT three dimensional reconstruction before surgery</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: 1) confirmed rectal cancer; 2) tumor located less than 10 cm from the&#xD;
        anus verge; 3) have enlarged lateral lymph on preoperative CT/MRI&#xD;
&#xD;
        Exclusion Criteria: 1) patients who have severe liver or renal dysfunction;&#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>Ziqiang Wang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Gastrointestinal Surgery, West China Hospital, Sichuan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ziqiang Wang, MD</last_name>
    <phone>+8618980602028</phone>
    <email>xbzhang262402@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ziqiang Wang, MD</last_name>
      <phone>+8618980602028</phone>
      <email>xbzhang262402@163.com</email>
    </contact>
    <investigator>
      <last_name>Xubing Zhang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Ziqiang Wang,MD</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <keyword>lateral lymph node dissection</keyword>
  <keyword>node-by-node</keyword>
  <keyword>rectal cancer</keyword>
  <keyword>CT three-dimensional reconstruction</keyword>
  <keyword>internal iliac vessels dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT03826862
org study id: LLND-2018
nct id: NCT03826862
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will perform CT three-dimension reconstruction for middle-low rectal cancer
      patients who have enlarged lateral lymph nodes to recognize the variance of pelvic vessels,
      by which to help reduce operative time and blood loss, localize the lateral lymph nodes,
      improve the lymph node harvested and positive rate. Besides, The investigators will label the
      vessels near the interested node to achieve node-by-node for further investigation.
CT three-dimensional reconstruction was performed for middle-low patients who had enlarged
      lateral lymph node before surgery. The main purpose is to recognize the track and variance of
      pelvic and iliac blood vessels. The investigators want to explore whether this method can
      help reduce operative time, unexpected injuries and blood loss, and The investigators also
      want to study whether it can help improve the lymph node harvested and positive rate during
      lateral lymph node dissection. Besides, The investigators want to perform node-by-node for
      enlarged lateral lymph node and CT three-dimensional reconstruction can help the
      investigators to localize and label the interested lymph node during operation. After
      node-by-node, The investigators can explore the accuracy of radiologists' and surgeons'
      judgement for lateral lymph node metastasis, and The investigators also want explore the best
      cut-off value of shorter diameter to predict lateral lymph node metastasis. Besides, The
      investigators want to perform texture analysis by combination radiology and pathology to find
      some useful parameters to predict lateral lymph node metastasis.

      The investigators also want to explore the feasibility of dissecting the unilateral visceral
      branch of internal iliac vessels when performing lateral lymph node dissection.

      The investigators will have a close follow-up for patients who have enlarged lateral lymph
      node but do not meet the criteria for lateral lymph node dissection. CT three-dimensional
      reconstruction can help The investigators recognize which parts' lateral lymph nodes have
      more potential possibility to metastasis and recurrence.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This group with intervention will be compared previous group without intervention.
primary purpose: Treatment
masking: None (Open Label)
measure: operative time
time frame: 2 year
description: including total operative time and that for lateral lymph node
measure: Blood loss
time frame: 2 year
description: intraoperative blood loss
measure: lateral lymph node harvested
time frame: 2 year
description: lateral lymph node harvested
measure: Accuracy of judgement for lateral lymph node metastasis
time frame: 2 year
description: including radiologists' and surgeons' accuracy
measure: Cut-off value of shorter diameter
time frame: 2 year
description: The best cut-off value of shorter diameter for lateral lymph node dissection
measure: vessels variances
time frame: October 1. 2018-December 31.2020
description: The blood vessels variance of internal iliac vessels
measure: postoperative complication
time frame: 2 year
description: including urinary and sexual function
measure: local recurrence rate
time frame: 3 year
description: local recurrence rate
measure: overall survival
time frame: 3 year
description: overall survival
measure: disease-free survival
time frame: 3 year
description: disease-free survival
arm group label: intervention group
arm group type: Experimental
description: All patients receive CT three-dimensional reconstruction before surgery.
arm group label: control group
arm group type: No Intervention
description: All patients did not receive CT three-dimensional before surgery
intervention type: Radiation
intervention name: CT three-dimensional reconstruction
description: All patients will receive CT three dimensional reconstruction before surgery
arm group label: intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ziqiang Wang, MD
role: Study Chair
affiliation: Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
last name: Ziqiang Wang, MD
phone: +8618980602028
email: xbzhang262402@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: West China Hospital
investigator full name: Ziqiang Wang,MD
investigator title: Clinical professor
mesh term: Rectal Neoplasms
sharing ipd: Undecided