<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/NCT04446494</url>
  </required_header>
  <id_info>
    <org_study_id>ZLYNXM202014</org_study_id>
    <nct_id>NCT04446494</nct_id>
  </id_info>
  <brief_title>Identification and Preservation of Arm Lymphatics</brief_title>
  <acronym>DEPART</acronym>
  <official_title>Identification and Preservation of Arm Lymphatics (DEPART) in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Multicenter Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan University</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>
      Controversy in axillary reverse mapping in axillary lymph node dissection (ALND) possibly&#xD;
      results from incomplete recognition of the arm lymphatic system (ALS) and its compromise to&#xD;
      oncological safety. The iDEntification and Preservation of ARm lymphaTics (DEPART) technique&#xD;
      facilitates complete identification of ALS; therefore, its use may decrease the occurrence of&#xD;
      arm lymphedema. This study aimed to examine the arm lymphedema rate, locoregional recurrence,&#xD;
      and feasibility to perform DEPART in ALND.&#xD;
&#xD;
      In the study group, indocyanine green and methylene blue (MB) were utilized to identify arm&#xD;
      sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the&#xD;
      subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by&#xD;
      intraoperative partial frozen section and were removed if positive. Arm lymphedema, local&#xD;
      recurrence, regional recurrence, and distant metastasis were recorded at different follow-up&#xD;
      examinations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of arm lymphedema</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>A difference in volume between the arms &lt; 10% was defined as lymphedema.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of locoregional recurrence</measure>
    <time_frame>5-year estimate reported after a median follow-up of 60 months</time_frame>
    <description>Locoregional recurrence included local recurrence and regional recurrence. Local recurrence was defined as chest wall recurrence of breast cancer, and regional recurrence was defined as the axilla recurrence of breast cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of distant metastasis</measure>
    <time_frame>5-year estimate reported after a median follow-up of 60 months</time_frame>
    <description>Cancer cells from breast metastasized to other organs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Breast Cancer Related Lymphedema</condition>
  <arm_group>
    <arm_group_label>Axillary dissection with DEPART technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental group, 1 ml (2.5 mg) indocyanine green (ICG) and methylene blue (MB) was intradermally injected into the internal bicipital sulcus of ipsilateral arm. During axillary dissection, the identified arm sentinel nodes were carefully injected with 0.1 ml methylene blue (MB) using a 1-cc syringe with a 32-gauge needle. MB could then flow from the nodes along several lymphatic channels toward the infraclavicular nodes. Subsequent-echelon nodes and lymphatics were identified. Sentinel lymph nodes (SLNs) were removed after the identification of the arm sentinel nodes and the procedure of MB injection. When patients harbored positive SLNs, axillary lymph node dissection (ALND) was performed subsequently. All discernible arm lymphatics and lymph nodes were preserved, except that gross arm lymph nodes (major axis larger than 10 mm or node firm on palpation) were sent for immediate partial frozen section (pFS) to determine their resection during ALND.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard axillary dissection</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control group (no intervention), ALND was performed with complete resection of at least Berg's levels I and II. Resection of level III was performed only in cases with gross disease in level II and/or III</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Identification and preservation of arm lymphatics (DEPART)</intervention_name>
    <description>Indocyanine green was utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive.</description>
    <arm_group_label>Axillary dissection with DEPART technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years or older with T1-3 invasive breast cancer;&#xD;
&#xD;
          -  Clinically node-positive breast cancer, defined as positive on preoperative axillary&#xD;
             palpation, ultrasound examination, and computed tomography scan with contrast;&#xD;
&#xD;
          -  Patients who underwent mastectomy with a positive sentinel lymph node (SLN);&#xD;
&#xD;
          -  Patients who underwent breast-conserving surgery containing more than two positive&#xD;
             SLNs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neoadjuvant chemotherapy;&#xD;
&#xD;
          -  Previous history of breast cancer.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qianqian Yuan, MD.</last_name>
    <phone>+8613026322297</phone>
    <email>Yuanqq11@whu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qianqian Yuan, MD.</last_name>
      <phone>+8613026322297</phone>
      <email>Yuanqq11@whu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Yuan Q, Wu G, Xiao SY, Hou J, Ren Y, Wang H, Wang K, Zhang D. Identification and Preservation of Arm Lymphatic System in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Randomized Clinical Trial. Ann Surg Oncol. 2019 Oct;26(11):3446-3454. doi: 10.1245/s10434-019-07569-4. Epub 2019 Jun 25.</citation>
    <PMID>31240591</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>December 7, 2020</last_update_submitted>
  <last_update_submitted_qc>December 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan University</investigator_affiliation>
    <investigator_full_name>Gaosong Wu, Ph D, MD</investigator_full_name>
    <investigator_title>Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>axillary lymph node dissection</keyword>
  <keyword>lymphedema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Breast Cancer Lymphedema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04446494
org study id: ZLYNXM202014
nct id: NCT04446494
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Controversy in axillary reverse mapping in axillary lymph node dissection (ALND) possibly
      results from incomplete recognition of the arm lymphatic system (ALS) and its compromise to
      oncological safety. The iDEntification and Preservation of ARm lymphaTics (DEPART) technique
      facilitates complete identification of ALS; therefore, its use may decrease the occurrence of
      arm lymphedema. This study aimed to examine the arm lymphedema rate, locoregional recurrence,
      and feasibility to perform DEPART in ALND.

      In the study group, indocyanine green and methylene blue (MB) were utilized to identify arm
      sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the
      subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by
      intraoperative partial frozen section and were removed if positive. Arm lymphedema, local
      recurrence, regional recurrence, and distant metastasis were recorded at different follow-up
      examinations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of arm lymphedema
time frame: Up to 2 years
description: A difference in volume between the arms < 10% was defined as lymphedema.
measure: Rate of locoregional recurrence
time frame: 5-year estimate reported after a median follow-up of 60 months
description: Locoregional recurrence included local recurrence and regional recurrence. Local recurrence was defined as chest wall recurrence of breast cancer, and regional recurrence was defined as the axilla recurrence of breast cancer.
measure: Rate of distant metastasis
time frame: 5-year estimate reported after a median follow-up of 60 months
description: Cancer cells from breast metastasized to other organs.
arm group label: Axillary dissection with DEPART technique
arm group type: Experimental
description: In the experimental group, 1 ml (2.5 mg) indocyanine green (ICG) and methylene blue (MB) was intradermally injected into the internal bicipital sulcus of ipsilateral arm. During axillary dissection, the identified arm sentinel nodes were carefully injected with 0.1 ml methylene blue (MB) using a 1-cc syringe with a 32-gauge needle. MB could then flow from the nodes along several lymphatic channels toward the infraclavicular nodes. Subsequent-echelon nodes and lymphatics were identified. Sentinel lymph nodes (SLNs) were removed after the identification of the arm sentinel nodes and the procedure of MB injection. When patients harbored positive SLNs, axillary lymph node dissection (ALND) was performed subsequently. All discernible arm lymphatics and lymph nodes were preserved, except that gross arm lymph nodes (major axis larger than 10 mm or node firm on palpation) were sent for immediate partial frozen section (pFS) to determine their resection during ALND.
arm group label: Standard axillary dissection
arm group type: No Intervention
description: In the control group (no intervention), ALND was performed with complete resection of at least Berg's levels I and II. Resection of level III was performed only in cases with gross disease in level II and/or III
intervention type: Procedure
intervention name: Identification and preservation of arm lymphatics (DEPART)
description: Indocyanine green was utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive.
arm group label: Axillary dissection with DEPART technique
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Qianqian Yuan, MD.
phone: +8613026322297
email: Yuanqq11@whu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Yuan Q, Wu G, Xiao SY, Hou J, Ren Y, Wang H, Wang K, Zhang D. Identification and Preservation of Arm Lymphatic System in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Randomized Clinical Trial. Ann Surg Oncol. 2019 Oct;26(11):3446-3454. doi: 10.1245/s10434-019-07569-4. Epub 2019 Jun 25.
PMID: 31240591
responsible party type: Principal Investigator
investigator affiliation: Wuhan University
investigator full name: Gaosong Wu, Ph D, MD
investigator title: Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University
mesh term: Breast Neoplasms
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema
sharing ipd: No