The Comparison Between M-E-BCS and C-O-BCS.
NCT07539545 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1366
Last updated 2026-04-20
Summary
This study is a multicenter, open-label, randomized controlled trial. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival) between patients undergoing M-E-BCS and patients undergoing C-O-BCS.
Conditions
Interventions
- PROCEDURE
-
Minimal accessory-incision-assisted endoscopic breast-conserving surgery
A small incision was made in the concealed area of the armpit, and a endoscopic device was inserted. Under direct vision, the tumor was precisely removed and the lymph nodes in the armpit were cleared layer by layer. The incision was then sutured layer by layer, and a drainage tube was placed after the operation.
- PROCEDURE
-
Conventional open breast-conserving surgery
Conventional open breast-conserving surgery is a surgical approach that aims to preserve the appearance and function of the breast as much as possible while ensuring the complete removal of the tumor. It is suitable for eligible patients with early-stage breast cancer and requires comprehensive postoperative treatment measures such as radiotherapy.
Sponsors & Collaborators
-
West China Fourth Hospital of Sichuan University
collaborator UNKNOWN -
West China Second University Hospital
collaborator OTHER -
The Fourth People's Hospital of Sichuan Province
collaborator UNKNOWN -
Taiyuan Central Hospital of Shanxi Medical University
collaborator OTHER -
Chengdu Second people's hospital
collaborator UNKNOWN -
Suzhou Municipal Hospital
collaborator OTHER -
Du Zhenggui
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2032-12-01
- Completion
- 2032-12-31
Countries
- China
Study Locations
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