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NCT Number: NCT07321145

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Surgery Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Haiyan Li

CONTACT

[email protected]

+86 15813340604

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Endoscopic breast-conserving surgery

Procedure

To perform breast-conserving surgery using a endoscopic system.

Primary outcomes

  1. Postoperative complication rate

    Time frame: 1 month postoperatively

Secondary outcomes

  1. Operation time

    Time frame: Intraoperative

  2. Aesthetic outcomes

    Time frame: 3 month postoperatively

    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. Blood loss

    Time frame: Perioperative

Study contacts

Contact information is provided by the study sponsor or research team.

Haiyan Li

CONTACT

[email protected]

+86 15813340604

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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