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Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Ultrasound-Assisted Tumor Surgery in Breast Cancer - A Prospective, Randomized, Single-Center Study (MAC 001)
Jürgen Hoffmann1, Mario Marx2, Andreas Hengstmann2
1Department of Gynecology and Obstetrics, University Hospital of Duesseldorf, Germany.
Ultrasound-guided breast surgery significantly improves the chances of achieving tumor-free margins, reducing the need for repeat surgeries. This technique should be adopted by breast surgeons to enhance patient outcomes.
Area of Science:
- Oncology
- Surgical Oncology
- Medical Imaging
Background:
- Breast-conserving surgery aims to remove tumors while preserving breast tissue.
- Achieving clear tumor margins is crucial to minimize recurrence risk.
- Wire-localization is a standard method for guiding surgery of non-palpable lesions, but can be associated with margin involvement.
Purpose of the Study:
- To compare the effectiveness of ultrasound-guided breast-conserving surgery versus traditional wire-guided surgery.
- To evaluate the impact of each surgical approach on tumor-free margin rates, resection volume, and surgical duration.
- To assess the reoperation rates associated with both surgical techniques.
Main Methods:
- A prospective, randomized, single-center controlled trial (MAC 001, NCT02222675) was conducted.
- Patients with ductal invasive breast cancer were randomized to either ultrasound-guided or wire-guided surgery.
- Primary outcomes included tumor-free resection margins, reoperation rates, and resection volume, analyzed by intention-to-treat.
Main Results:
- Ultrasound-guided surgery achieved significantly higher rates of tumor-free margins (93%) compared to wire-guided surgery (65%) (p=0.026).
- No significant differences were observed in resection volume or surgical duration between the two groups.
- No major complications were reported in either surgical arm.
Conclusions:
- Ultrasound-assisted breast surgery substantially increases the likelihood of achieving tumor-free margins, thereby reducing reoperation rates.
- Training breast surgeons in ultrasound techniques and ensuring its availability in operating rooms is recommended.
- This approach enhances the efficacy of breast-conserving therapy.
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