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

NCT07321145 | Recruiting

• 1 other identifier: 2025ZSLYEC-374
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Breast Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative complication rate

  1 month postoperatively

Secondary Outcomes (3)

• Operation time

  Intraoperative

• Aesthetic outcomes

  3 month postoperatively

• Blood loss

  Perioperative

Study Arms (2)

Endoscopic breast-conserving surgery

ACTIVE COMPARATOR

Procedure: Endoscopic breast-conserving surgery

Robotic breast-conserving surgery

EXPERIMENTAL

Procedure: Robotic breast-conserving surgery

Interventions

Robotic breast-conserving surgery PROCEDURE

To perform breast-conserving surgery using a robotic system, thereby validating the safety and feasibility of robotic breast-conserving surgery.

Robotic breast-conserving surgery

Endoscopic breast-conserving surgery PROCEDURE

To perform breast-conserving surgery using a endoscopic system.

Endoscopic breast-conserving surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Haiyan Li

CONTACT

+86 15813340604; lihy27@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: January 6, 2026
• Study Start: June 27, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)