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

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Sun Yat-sen University

Status

Enrolling

Conditions

Breast Cancer
Breast Surgery

Treatments

Procedure: Robotic breast-conserving surgery
Procedure: Endoscopic breast-conserving surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT07321145
2025ZSLYEC-374

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Endoscopic breast-conserving surgery
Active Comparator group
Treatment:
Procedure: Endoscopic breast-conserving surgery
Robotic breast-conserving surgery
Experimental group
Treatment:
Procedure: Robotic breast-conserving surgery

Trial contacts and locations

1

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Central trial contact

Haiyan Li

Data sourced from clinicaltrials.gov

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