ESM Versus OM ：A Randomized Controlled Trial

NCT04461847 | Unknown

• 1 other identifier: BFH-BC
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Subcutaneous Mastectomy

Outcome Measures

Primary Outcomes (1)

• local recurrence rate

  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 Outcomes (1)

• Distant metastasis

  12 months after operation

Study Arms (2)

patients underwent ESM

EXPERIMENTAL

Procedure: endoscopic subcutaneous mastectomy

patients underwent SM

ACTIVE COMPARATOR

Procedure: subcutaneous mastectomy

Interventions

subcutaneous mastectomy PROCEDURE

Operating subcutaneous mastectomy

patients underwent SM

endoscopic subcutaneous mastectomy PROCEDURE

Operating endoscopic subcutaneous mastectomy

patients underwent ESM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• Wang ZH, Ding G, Wu S, Song JN, Ge ZC, Zhang H, Yuan Z, Gao YG, Gang TR, Zhang Z, Qu X. Oncological outcome of single-port insufflation endoscopic nipple-sparing mastectomy versus open mastectomy in early breast cancer patients: a study protocol for a randomised controlled trial. BMJ Open. 2022 May 2;12(5):e047866. doi: 10.1136/bmjopen-2020-047866.

  PMID: 35501091 DERIVED

MeSH Terms

Interventions

Mastectomy, Subcutaneous

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of general surgery, principal investigator

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: July 8, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

CN (1)