Endoscopic Skin-Sparing vs. Conventional Mastectomy for Wound Complications in BC

April 21, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

A Multicenter, Randomized, Controlled, Open-Label Study Comparing Endoscopic Skin-Sparing Mastectomy With Conventional Mastectomy for Wound Complications in Patients With Breast Cancer

This randomized, open-label study compares endoscopic skin-sparing mastectomy (E-SSM) with conventional mastectomy (CM) in female patients with unilateral invasive breast cancer (T1-4aN0-3M0). The primary objective is to evaluate differences in postoperative wound complications and patient satisfaction, with secondary outcomes including breast appearance and oncological safety.

Eligible patients have a breast volume ≤ cup C and no/mild ptosis (grade I-II). A total of 258 participants (129 per group) will be enrolled across multiple centers and randomized by site.

This study aims to provide evidence for selecting optimal endoscopic surgical strategies, address the evidence gap for E-SSM without immediate reconstruction, and advance the precision of breast cancer surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged 18 to 75 years
  • Pathologically confirmed invasive breast cancer
  • Clinical stage cT1-4a N0-3 M0
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Unilateral breast cancer
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Hematological and renal function with the following parameters: White blood cell count ≥ 3.0 × 10⁹/L; Neutrophil count ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
  • No planned breast reconstruction

Exclusion Criteria:

  • Tumor invasion of the skin
  • Diffuse malignant microcalcifications
  • Breast cancer during pregnancy or lactation
  • History of another primary malignancy
  • Severe cardiopulmonary, hepatic or renal dysfunction, or other significant systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-SSM
endoscopic skin-sparing mastectomy
Procedure: Endoscopic skin-sparing mastectomy
Endoscopic skin-sparing mastectomy (E-SSM). Under endoscopic assistance, the breast skin and partial subcutaneous tissue are preserved, while the breast parenchyma, and nipple-areola complex are resected according to oncological principles. This approach aims to maintain breast envelope integrity while ensuring oncological safety.
Active Comparator: CM
conventional mastectomy
Procedure: Conventional mastectomy
Conventional mastectomy (CM). The breast tissue, nipple-areola complex, and a full thickness of skin and subcutaneous tissue within the traditional resection range are removed. This is the standard surgical approach for breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Complication Rate
Time Frame: occurring prior to completion of adjuvant chemotherapy and radiotherapy, about 6-12 months postoperatively
Wound complications are defined as wound dehiscence requiring surgical debridement, dressing change, or packing, or persistent wound discharge, occurring prior to completion of adjuvant chemotherapy and radiotherapy. The rate is calculated as: (Number of patients with ≥1 wound complication / Total surgical patients in the group) × 100%
occurring prior to completion of adjuvant chemotherapy and radiotherapy, about 6-12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 6 months postoperatively
Breast satisfaction score from the Breast Q questionnaire at 6 months postoperatively. Patients will complete the self-reported Breast Q survey under physician guidance, which takes 1-4 minutes for the breast satisfaction module and 10-15 minutes for the full survey.
6 months postoperatively
Postoperative Breast Appearance
Time Frame: 6 months postoperatively
Overall aesthetic score using the Ueda scale (0-10, 0=poor, 10=excellent) assessed by physicians, and scar appearance score using the Scar-Q scale (0-100, 4 domains) self-reported by patients, both evaluated at 6 months postoperatively.
6 months postoperatively
Surgical Time
Time Frame: intraoperative
Time from initial incision to completion of wound closure, measured in minutes.
intraoperative
Intraoperative Blood Loss
Time Frame: intraoperative
Total volume of blood lost during surgery, measured in milliliters (mL).
intraoperative
Rate of Other Postoperative Adverse Complications
Time Frame: up to 24 months
Percentage of patients experiencing other postoperative complications (e.g., edema, bleeding) during the follow-up period, calculated as: (Number of patients with ≥1 other complication / Total patients in the group) × 100%
up to 24 months
Overall Survival (OS)
Time Frame: From date of surgery until the date of death from any cause, assessed up to 60 months
Time from the date of surgery to death from any cause. Patients who remain alive will be censored at the last follow-up date.
From date of surgery until the date of death from any cause, assessed up to 60 months
Disease-Free Survival (DFS)
Time Frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Defined as the time from the date of surgery to the first occurrence of any of the following events: local recurrence, regional recurrence, distant metastasis, or death from any cause. Patients without any event were censored at the last follow-up date.
From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Shicheng Su, Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2025-809-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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