Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial

Summary

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.

Abstract

The integration of robotic platforms in breast oncology has witnessed substantial expansion, fueled by their inherent advantages in minimally invasive access and enhanced intraoperative maneuverability. Most of the robotic-assisted breast surgery has been performed using multi-arm robots. However, the implementation of single-port robotic (SPr) systems in mammary interventions continues to undergo rigorous clinical evaluation, particularly regarding long-term oncological safety and cost-effectiveness metrics. Notably, multi-arm robotic systems demonstrate constrained operability in the restricted mammary workspace, whereas the transaxillary, single-port approach demonstrates enhanced spatial adaptability, achieving more optimal instrument articulation in confined surgical fields while concurrently optimizing aesthetic outcomes through precise subcutaneous tissue dissection. The study (ClinicalTrials.gov ID: NCT06738654) constituted a prospective, single-arm, non-randomized trial for primary exploration of feasibility and safety regarding a single-port robotic system in breast-conserving surgery (BCS) in six patients with early-stage breast cancer undergoing transaxillary, SPr-assisted, partial mastectomy with sentinel lymph node biopsy (SLNB). A total of 6 patients from Daping Hospital (Army Medical Center) between December 2024 and February 2025 were included in this study, with the first successful implementation performed on December 24, 2024. Intraoperative frozen-section histopathology confirmed negative resection margins in all patients, meeting the criteria for surgical success. The mean operative time was 232 min, with an average postoperative drainage volume of 250 mL. The axillary drainage tubes remained for an average of 10 days; the mean hospital stay was 10 days. Quality of life assessment through FACT-B demonstrated satisfaction scores. The six cases demonstrate the procedural safety and oncological feasibility of transaxillary SPr-assisted BCS within minimally invasive breast oncology. Mechanistically, the axillary portal approach achieves scar containment through only one incision in the inframammary fold, while preserving the native breast architecture. This technique significantly improves postoperative quality of life metrics through precise subcutaneous fascia preservation, reducing psycho-emotional distress associated with visible scarring. The technical paradigm aligns with oncoplastic principles by reconciling radical tumor excision with contemporary aesthetic demands in breast cancer candidates.

Introduction

Globally ranking as the second most prevalent malignancy (11.6% of new cancer diagnoses), breast cancer demonstrates an escalating incidence with earlier onset patterns^1,2. Surgery remains the primary treatment for breast cancer. The historical trajectory of breast cancer surgery has been characterized by the emergence of multiple surgical techniques. This evolution spans from Halsted's radical mastectomy in 1882 to the emergence of BCS in the 1980s. Breast cancer is not merely a localized disease confined to the breast, representing rather a systemic illness. While surgery remains unavoidable, BCS outperf....

Protocol

Ethical clearance for this study was granted by the Ethics Committee of the Army Medical Center, and the trial is officially registered on ClinicalTrials.gov with a unique identifier (NCT06738654). Six patients with early-stage breast cancer undergoing transaxillary, SPr-assisted, partial mastectomy with sentinel lymph node biopsy (SLNB) were enrolled at the Army Medical Center (IRB approval No. 341[2024]). Written informed consent was secured from all participants before their enrollment in the study. All anesthesia-related supplies have been used under the direct supervision of licensed anesthesiologists, with real-time documentation of drug administration and waste....

Results

The mean operative time for the six patients was 232 min (min: 180 min, max: 295 min), and the mean intraoperative blood loss was 15 mL (min: 10 mL, max: 30 mL). The average postoperative drainage volume was 250 mL (min: 100 mL, max: 470 mL). The axillary drainage tubes remained for an average of 10 days (min: 4 days, max: 17 days). The mean hospital stay was 10 days (min: 8 days, max: 16 days), with the longest stay attributed to postoperative breast hematoma.

Three of the six patients underw.......

Discussion

The successful execution of single-port, robotic-assisted, partial mastectomy via axillary approach in six patients underscores the viability of SPr systems for BCS, with the first successful implementation performed on December 24, 2024. The critical surgical techniques involve prerobotic docking cavity creation and delineation of extended resection margins in BCS. Optimal cavity creation minimizes instrumental access challenges imposed by anatomical constraints while maximizing surgical field exposure. Intraoperative f.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Bipolar coagulating forceps	Edge Medical,CHINA	SP1000	Mian surgery instrument ___
Cisatracurium Besilate Injection	NanJing JIAN YOU, CHIINA	___	Anesthetic drug 5 mL, 10 mg
Disposable multi-channel single-port laparoscopic trocar	SHIAIDE XIAMEN,CHINA	20240708006	Connect the robot II A, 4E-70 x 150
Epinephrine Hydrochloride Injection	DIKANG CHONGQING,CHINA	___	Decrease blood 1 mL, 1 mg
Etomidate Injectable Emulsion	Jiangsu Nhwa Pharmaceutical Co, CHINA	___	Anesthetic drugV 10 mL
Lidocaine Hydrochloride Injection	TIANSHENG HUBEI,CHINA	___	Decrease blood 5 mL, 0.1 g
Methylthioninum Chloride	JUMPCAN PHARMACEUTICAL GROUP CO.LTD	___	Dying 2 mL, 20 mg
Midazolam Injection	Jiangsu Nhwa Pharmaceutical Co, CHINA	___	Anesthetic drug 10 mg
Monopolar electric scissors	Edge Medical,CHINA	SP1000	Mian surgery instrument ___
Negative pressure drainage bottle	B.Braun,Germany	5523443	Drainage ___
Ropivacaine Hydrochloride Injection	JIABO GUANGDONG,CHINA	___	Decrease blood 10 mL, 100 mg
Rubber gloves	YADU Medical,CHINA	___	Connect the robot 7.5
Single-Port Laparoscopic Surgical Robot	Edge Medical,CHINA	SP1000	Mian surgery instrument JingFeng Single-Port Laparoscopic Surgical Robot SP1000
Sodium Chloride Injection	HUALU SHANDONG,CHINA	___	Prepare the solution in proportion 100 mL, 0.9%
Sufentanil Citrate Injection	RenFU Medical, CHINA	___	Anesthetic drug 1 mL, 50 μg
Synthetic suture	Covidien,American	___	Close the wound 4-0/GL181 or 4-0/GL34MG
Syringe	DONGBEI Medical,CHINA	___	Limit the boundary 10 mL