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

NCT ID: NCT07321145

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Breast Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic breast-conserving surgery

Group Type ACTIVE_COMPARATOR

Endoscopic breast-conserving surgery

Intervention Type PROCEDURE

To perform breast-conserving surgery using a endoscopic system.

Robotic breast-conserving surgery

Group Type EXPERIMENTAL

Robotic breast-conserving surgery

Intervention Type PROCEDURE

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

Interventions

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Robotic breast-conserving surgery

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

Intervention Type PROCEDURE

Endoscopic breast-conserving surgery

To perform breast-conserving surgery using a endoscopic system.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haiyan Li

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haiyan Li

Role: CONTACT

+86 15813340604

Facility Contacts

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Haiyan Li

Role: primary

+86 15813340604

Other Identifiers

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2025ZSLYEC-374

Identifier Type: -

Identifier Source: org_study_id

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