ESM Versus OM ：A Randomized Controlled Trial

Not Applicable

• Conditions: Endoscopic Subcutaneous Mastectomy
• Interventions: Procedure: subcutaneous mastectomy; Procedure: endoscopic subcutaneous mastectomy

• Registration Number: NCT04461847
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-28
• Study Start: 2020-12-01
• Last Update Posted: 2020-12-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 287

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients underwent SM	subcutaneous mastectomy	-
patients underwent ESM	endoscopic subcutaneous mastectomy	-

Primary Outcome Measures

Name	Time	Method
local recurrence rate	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.

Secondary Outcome Measures

Name	Time	Method
Distant metastasis	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.

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China