Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
August 19th, 2025
This prospective study evaluated the implementation of a novel, single-port, robotic platform in oncoplastic breast-conserving surgery for malignant lesions. The primary endpoint focused on technical success, defined as the achievement of tumor-free resection margins confirmed by intraoperative frozen-section histopathology, with secondary assessment of aesthetic outcomes and life quality score of patients.
The focus of our study is application of single-port robotic technology in breast cancer surgery. Its aim is to address effectiveness and safety of the novel single-port robotic technology. in breast-conserving surgery for breast cancer.
The experimental challenge is to improve the recognition rate of tumor boundaries, reduce the positive rates of surgical margins, and lower the incidences of array operation. We performed the first successful application of single-port robotics in breast-conserving surgery for breast cancer in China. To begin, use the single-port robotic camera to establish visualization of the surgical area.
Guide the instruments along the lateral border of the pectoralis major muscle to access the retropectoral tissue. Using gentle palpation, confirm the boundaries of the dissection zone. Then extend the retromammary dissection by one to two centimeters beyond the target area, and mark the boundaries using 10 syringe needle markers.
Next, deploy the single-port robotic monopolar scissors and bipolar forceps. Enter the resection zone through the superficial fascial layer and perform a vertical lateral resection from the superior to the inferior direction. Now, continue resecting bilaterally to achieve complete cylindrical gland removal.
Finally, deactivate and withdraw all robotic components. Inspect the retrieved specimen, grossly to confirm tumor presence. Photograph the lesion with anatomical orientation markers, then submit the specimen for pathological evaluation.
The mean operative time across six patients was 232 minutes, ranging from 180 minutes to 295 minutes, and the mean intraoperative blood loss was 15 milliliters. The average postoperative drainage volume was 250 milliliters with values ranging from 100 milliliters to 470 milliliters. The mean hospital stay was 10 days, ranging from eight days to 16 days, with the longest stay linked to postoperative breast hematoma.
Postoperative cosmetic outcomes demonstrated progressive improvement with improved BREAST-Q scores. Early postoperative pain management achieved target Visual Analog Scale scores, starting at 4 on day one and remaining less than 2 in later stages.
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Overview
This study evaluates the use of a novel single-port robotic platform in breast-conserving surgery for malignant lesions. The focus is on technical success and patient outcomes.
Key Study Components
Area of Science
- Robotic surgery
- Oncoplastic surgery
- Breast cancer treatment
Background
- Breast-conserving surgery is crucial for malignant lesions.
- Single-port robotic technology aims to enhance surgical precision.
- Improving tumor boundary recognition is essential for successful outcomes.
- Reducing positive surgical margins is a key challenge.
Purpose of Study
- To assess the effectiveness of single-port robotic technology in surgery.
- To evaluate the safety of this novel approach.
- To improve aesthetic outcomes and quality of life for patients.
Methods Used
- Implementation of a single-port robotic platform.
- Intraoperative frozen-section histopathology for margin assessment.
- Evaluation of aesthetic outcomes post-surgery.
- Quality of life scoring for patients after the procedure.
Main Results
- Successful application of single-port robotics in surgery.
- Achievement of tumor-free resection margins.
- Positive aesthetic outcomes reported by patients.
- Improved quality of life scores observed.
Conclusions
- Single-port robotic technology is effective in breast-conserving surgery.
- It enhances surgical precision and patient outcomes.
- This approach may set a new standard in oncoplastic surgery.
Frequently Asked Questions
Executive Industry Relevance
Single-port robotic-assisted transaxillary breast-conserving surgery (SPr-BCS) addresses the challenge of achieving precise tumor excision with minimal invasiveness and optimal cosmetic outcomes in early-stage breast cancer. This approach enhances intraoperative maneuverability and spatial adaptability, supporting predictive confidence in surgical margin status and patient quality of life. Its integration into the surgical oncology pipeline offers a platform for standardizing minimally invasive, oncoplastic procedures with enterprise-wide impact.
Strategic Applications in Biopharma R&D
Early Discovery & Target Validation
- Enables rigorous evaluation of surgical margin status through intraoperative frozen-section histopathology.
- Supports mechanistic de-risking by improving tumor boundary recognition and reducing positive margin rates.
- Facilitates functional validation of minimally invasive surgical platforms in disease-relevant settings.
Screening & Assay Development
- Establishes reproducible protocols for intraoperative tissue assessment and specimen orientation.
- Standardizes quantitative outputs such as operative time, blood loss, and drainage volume for benchmarking.
- Prepares validated surgical workflows for downstream clinical and translational research.
Translational & Preclinical Research
- Aligns surgical technique with oncoplastic and patient-centered outcome measures, including quality of life and cosmetic scores.
- Provides continuity from surgical innovation to patient-reported outcomes, supporting translational biomarker development.
- Enables risk-adjusted advancement of minimally invasive platforms in breast oncology portfolios.
Pipeline & Workflow Integration
SPr-BCS integrates into the surgical oncology continuum from early feasibility to translational validation, supporting both technical and patient-centered endpoints.
- Discovery Biology: Advances hypothesis testing for margin negativity and tissue preservation in confined anatomical spaces.
- Screening: Delivers reproducible intraoperative and postoperative metrics for cross-study comparison.
- Analytics: Provides quantitative readouts—operative time, drainage, pain scores—for robust condition comparison.
- Translational Research: Links surgical innovation to patient quality of life and aesthetic outcomes, informing biomarker alignment.
- Enterprise Reuse: Establishes a scalable, single-port robotic workflow adaptable across minimally invasive oncology indications.
Operational & Enterprise Impact
- Scientific Value: Increases predictive confidence in surgical margin status and reduces mechanistic ambiguity in tissue excision.
- Operational Value: Standardizes minimally invasive workflows with reproducible, quantitative outputs.
- Strategic Value: Enables informed go/no-go decisions for surgical platform adoption and resource allocation.
- Portfolio Impact: Supports risk-adjusted prioritization of innovative surgical technologies in oncology pipelines.
Implementation Considerations
- Requires specialized expertise in robotic-assisted and oncoplastic breast surgery.
- Demands access to advanced single-port robotic instrumentation and intraoperative pathology support.
- Necessitates cross-team standardization of specimen handling and outcome measurement.
- May require adaptation for anatomical variability and broader patient populations.
- Current evidence is limited to early-stage feasibility and safety in a small cohort.
