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ESM Versus OM ：A Randomized Controlled Trial

NCT ID: NCT04461847

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Endoscopic Subcutaneous Mastectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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patients underwent ESM

Group Type EXPERIMENTAL

endoscopic subcutaneous mastectomy

Intervention Type PROCEDURE

Operating endoscopic subcutaneous mastectomy

patients underwent SM

Group Type ACTIVE_COMPARATOR

subcutaneous mastectomy

Intervention Type PROCEDURE

Operating subcutaneous mastectomy

Interventions

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subcutaneous mastectomy

Operating subcutaneous mastectomy

Intervention Type PROCEDURE

endoscopic subcutaneous mastectomy

Operating endoscopic subcutaneous mastectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongtao Zhang

Director of general surgery, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhongtao Zhang,, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35501091 (View on PubMed)

Other Identifiers

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BFH-BC

Identifier Type: -

Identifier Source: org_study_id