A Randomized Controlled Trial of Endoscopic Subcutaneous Mastectomy Versus Open Mastectomy in Early Breast Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 287
- Locations
- 1
- Primary Endpoint
- local recurrence rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of stages I or II ductal carcinoma
- •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
- •Age from 18~70
- •ECOG scores 0~2
- •Normal function of liver, kidney and bone marrow
Exclusion Criteria
- •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.
- •There are serious medical diseases
- •Pregnant or lactating women women of childbearing age -
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Distant metastasis(12 months after operation)
Investigators
Zhongtao Zhang
Director of general surgery, principal investigator
Beijing Friendship Hospital