ESM Versus OM ：A Randomized Controlled Trial

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04461847

Collaborator

(none)

287

Enrollment

Location

Arms

Anticipated Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Subcutaneous Mastectomy	Procedure: subcutaneous mastectomy Procedure: endoscopic subcutaneous mastectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

287 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital	Beijing	Beijing	China	100050

Sponsors and Collaborators

Beijing Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhongtao Zhang, Director of general surgery, principal investigator, Beijing Friendship Hospital

ClinicalTrials.gov Identifier:

NCT04461847

Other Study ID Numbers:

BFH-BC

First Posted:

Jul 8, 2020

Last Update Posted:

Dec 1, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 1, 2020