ESM Versus OM ：A Randomized Controlled Trial

November 28, 2020 updated by: Zhongtao Zhang, Beijing Friendship Hospital

A Randomized Controlled Trial of Endoscopic Subcutaneous Mastectomy Versus Open Mastectomy in Early Breast Cancer Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

287

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Diagnosis of stages I or II ductal carcinoma
  2. The distance from the tumor to the edge of the papilla is more than 3cm, the tumor volume is less than 3cm, the axillary lymph nodes have no obvious fusion and no adhesion with the axillary vein and brachial plexus
  3. Age from 18~70
  4. ECOG scores 0~2
  5. Normal function of liver, kidney and bone marrow

Exclusion Criteria:

  1. Through physical examination and MRI, it was confirmed that the tumor did not invade the skin, but was confined to the gland and did not invade the surface of the gland.
  2. There are serious medical diseases
  3. Pregnant or lactating women women of childbearing age -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients underwent ESM
Procedure: endoscopic subcutaneous mastectomy
Operating endoscopic subcutaneous mastectomy
Active Comparator: patients underwent SM
Procedure: subcutaneous mastectomy
Operating subcutaneous mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local recurrence rate
Time Frame: 12 months after operation
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.
12 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant metastasis
Time Frame: 12 months after operation
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.
12 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 28, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • BFH-BC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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