<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/NCT04461847</url>
  </required_header>
  <id_info>
    <org_study_id>BFH-BC</org_study_id>
    <nct_id>NCT04461847</nct_id>
  </id_info>
  <brief_title>ESM Versus OM ：A Randomized Controlled Trial</brief_title>
  <official_title>A Randomized Controlled Trial of Endoscopic Subcutaneous Mastectomy Versus Open Mastectomy in Early Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship 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 consideration of quality of life issues has led to the development of alternative&#xD;
      surgeries for breast cancer patients, particularly in the case of localized disease.&#xD;
      Nipple-sparing subcutaneous mastectomy (SM), for example, was designed to preserve the&#xD;
      nipple-areola complex which facilitates breast reconstruction. However, SM still leaves&#xD;
      behind a conspicuous scar.There have already been some observation study show that endoscopic&#xD;
      subcutaneous mastectomy(ESM) can improve the cosmesis outcomes and at the same time as safe&#xD;
      as the traditional SM.However there is no RCT in this field.That is why the investigators&#xD;
      design this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>local recurrence rate</measure>
    <time_frame>12 months after operation</time_frame>
    <description>Definition and diagnostic criteria of local recurrence: physical examination or imaging examination found lesions in the same side of breast, chest wall or skin and surgical scars, and confirmed by histology as breast cancer of the same tissue type; 12 months after operation, the evaluation was carried out.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis</measure>
    <time_frame>12 months after operation</time_frame>
    <description>Definition and diagnosis criteria of distant metastasis: the lesions appeared in the distant organs other than breast and surrounding tissues, such as bone, lung, liver, brain, etc., and were diagnosed as breast cancer metastasis by imaging or histology; the evaluation was carried out 12 months after operation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">287</enrollment>
  <condition>Endoscopic Subcutaneous Mastectomy</condition>
  <arm_group>
    <arm_group_label>patients underwent ESM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>patients underwent SM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>subcutaneous mastectomy</intervention_name>
    <description>Operating subcutaneous mastectomy</description>
    <arm_group_label>patients underwent SM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endoscopic subcutaneous mastectomy</intervention_name>
    <description>Operating endoscopic subcutaneous mastectomy</description>
    <arm_group_label>patients underwent ESM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of stages I or II ductal carcinoma&#xD;
&#xD;
          2. The distance from the tumor to the edge of the papilla is more than 3cm, the tumor&#xD;
             volume is less than 3cm, the axillary lymph nodes have no obvious fusion and no&#xD;
             adhesion with the axillary vein and brachial plexus&#xD;
&#xD;
          3. Age from 18~70&#xD;
&#xD;
          4. ECOG scores 0~2&#xD;
&#xD;
          5. Normal function of liver, kidney and bone marrow&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Through physical examination and MRI, it was confirmed that the tumor did not invade&#xD;
             the skin, but was confined to the gland and did not invade the surface of the gland.&#xD;
&#xD;
          2. There are serious medical diseases&#xD;
&#xD;
          3. Pregnant or lactating women women of childbearing age -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhongtao Zhang,, MD</last_name>
      <phone>+86-13801060364</phone>
      <email>zhangzht@ccmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>April 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>November 28, 2020</last_update_submitted>
  <last_update_submitted_qc>November 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Zhongtao Zhang</investigator_full_name>
    <investigator_title>Director of general surgery, principal investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT04461847
org study id: BFH-BC
nct id: NCT04461847
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The consideration of quality of life issues has led to the development of alternative
      surgeries for breast cancer patients, particularly in the case of localized disease.
      Nipple-sparing subcutaneous mastectomy (SM), for example, was designed to preserve the
      nipple-areola complex which facilitates breast reconstruction. However, SM still leaves
      behind a conspicuous scar.There have already been some observation study show that endoscopic
      subcutaneous mastectomy(ESM) can improve the cosmesis outcomes and at the same time as safe
      as the traditional SM.However there is no RCT in this field.That is why the investigators
      design this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: local recurrence rate
time frame: 12 months after operation
description: Definition and diagnostic criteria of local recurrence: physical examination or imaging examination found lesions in the same side of breast, chest wall or skin and surgical scars, and confirmed by histology as breast cancer of the same tissue type; 12 months after operation, the evaluation was carried out.
measure: Distant metastasis
time frame: 12 months after operation
description: Definition and diagnosis criteria of distant metastasis: the lesions appeared in the distant organs other than breast and surrounding tissues, such as bone, lung, liver, brain, etc., and were diagnosed as breast cancer metastasis by imaging or histology; the evaluation was carried out 12 months after operation.
arm group label: patients underwent ESM
arm group type: Experimental
arm group label: patients underwent SM
arm group type: Active Comparator
intervention type: Procedure
intervention name: subcutaneous mastectomy
description: Operating subcutaneous mastectomy
arm group label: patients underwent SM
intervention type: Procedure
intervention name: endoscopic subcutaneous mastectomy
description: Operating endoscopic subcutaneous mastectomy
arm group label: patients underwent ESM
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Zhongtao Zhang
investigator title: Director of general surgery, principal investigator