A Retrospective Analysis of Robot-Assisted Versus Endoscopic Breast-Conserving Surgery for Breast Cancer

Robotic surgical systems provide notable advantages including enhanced dexterity, a magnified three-dimensional high-definition view, and high-resolution imaging, thereby improving operative stability and precision. These features make robotic systems particularly suitable for procedures performed within confined operative spaces. As the breast is a solid organ without a natural cavity, robotic systems demonstrate strong adaptability for breast surgery. Robot-assisted breast-conserving surgery (RABCS) is one of the currently utilized robotic techniques in clinical breast cancer surgery. However, as robotic breast surgery remains in its early stage of development, evidence regarding the clinical outcomes of RABCS remains limited in the literature. Therefore, this study compares the surgical outcomes of endoscopic breast-conserving surgery and robot-assisted breast-conserving surgery in breast cancer patients, aiming to assess and elucidate the clinical value of RABCS.

Study Overview

• Status: Recruiting
• Conditions: Breast Surgery; Breast Cancer
• Intervention / Treatment: Procedure: Endoscopic breast-conserving surgery; Procedure: Robotic breast-conserving surgery

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiyan Li; Phone Number: +86 15813340604; Email: lihy27@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The sixth affiliated hospital of Sun Yat-Sen University
      • Contact: Haiyan Li; Phone Number: +86 15813340604; Email: lihy27@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patients aged 18 to 80 years
• Pathologically confirmed breast cancer prior to surgery
• Sufficient glandular volume with a tumor-to-breast volume ratio ≤20%
• A unifocal lesion confined to the glandular tissue
• Clear desire for breast conservation and willingness to undergo R-BCS or E-BCS
• No evidence of distant metastasis, no involvement of the skin or chest wall
• Eligibility for standard postoperative radiotherapy

Exclusion Criteria:

• The presence of diffuse suspicious lesions or microcalcifications for which wide local resection was unlikely to achieve adequate negative margins or satisfactory aesthetic outcomes
• Bilateral breast cancer or inflammatory breast cancer
• After neoadjuvant therapy, requirement for additional concurrent surgical procedures
• Inability to tolerate general anesthesia or undergo surgery
• Contraindications to radiotherapy or a history of prior chest wall irradiation, pregnancy- or lactation-associated breast cancer
• Refuse to undergo R-BCS or E-BCS

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endoscopic breast-conserving surgery	Procedure: Endoscopic breast-conserving surgery; To perform breast-conserving surgery using a endoscopic system.
Experimental: Robotic breast-conserving surgery	Procedure: Robotic breast-conserving surgery; To perform breast-conserving surgery using a robotic system, thereby validating the safety and feasibility of robotic breast-conserving surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative complication rate	1 month postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time		Intraoperative
Aesthetic outcomes	We utilized the novel assessment tool developed by Lai et al. tailored to minimally invasive breast surgery, with specific attention to scar length, appearance, and position. References: Lai HW, Mok CW, Chang YT, Chen DR, Kuo SJ, Chen ST. Endoscopic assisted breast conserving surgery for breast cancer: Clinical outcome, learning curve, and patient reported aesthetic results from preliminary 100 procedures. Eur J Surg Oncol. 2020;46(8):1446-1455. doi:10.1016/j.ejso.2020.02.020	3 month postoperatively
Blood loss		Perioperative

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2025ZSLYEC-374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No