Robotic-Assisted Versus Endoscopic-Assisted Axillary Lymph Node Dissection in Breast Cancer

Condition(s) studied

Study summary

This is a multicenter, retrospective observational study comparing the safety and efficacy of robotic-assisted versus endoscopic-assisted axillary lymph node dissection (ALND) in patients with node-positive breast cancer. The study aims to evaluate the protective effect on the intercostobrachial nerve (ICBN), perioperative outcomes, postoperative complications, and quality of life between the two minimally invasive techniques, as well as to assess long-term oncological outcomes including axillary recurrence and survival. Data will be extracted from routine clinical records. The study will compare the robotic group and the endoscopic group with respect to the following outcome measures:

1. ICBN-related sensory outcomes: incidence of sensory impairment (light touch, pinprick, cold, and warm sensations) in four key regions innervated by the ICBN (medial upper arm, axilla, lateral chest wall, and upper chest wall) assessed using standardized bedside sensory testing and sensory scoring systems;
2. Perioperative outcomes: including but not limited to operative time, estimated blood loss, number of lymph nodes dissected, length of hospital stay, drainage duration and axillary neurotomy;
3. Postoperative complications: including but not limited to seroma, hematoma, wound infection, lymphedema, and shoulder dysfunction;
4. Pain and functional outcomes: including but not limited to postoperative pain assessed by the Verbal Rating Scale (VRS), upper limb function assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) score, and quality of life assessed by the Functional Assessment of Cancer Therapy - Breast + 4 (FACT B+4) questionnaire;
5. Oncological outcomes: including but not limited to axillary recurrence, locoregional recurrence, distant metastasis, disease-free survival (DFS), and overall survival (OS), with a minimum follow-up period to be determined based on data availability.

This study has been approved by the Research Ethics Committee of Guangzhou Medical University Affiliated Women and Children's Medical Center. A waiver of informed consent has been granted due to the retrospective nature of the study. All patient data will be anonymized and kept confidential. Statistical analyses will be performed using R, SPSS and GraphPad Prism, with a P value \< 0.05 considered statistically significant.

Eligibility

Primary outcome measure(s)

• Incidence of Sensory Impairment in Intercostobrachial Nerve Innervated Regions — At postoperative follow-up assessments (e.g., 1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability)
  Sensory function assessed in four key regions innervated by the intercostobrachial nerve (ICBN): medial upper arm, axilla, lateral chest wall, and upper chest wall. Four sensory modalities are evaluated using standardized bedside sensory testing: light touch, pinprick, cold sensation, and warm sensation. The evaluation of sensory impairment includes the following dimensions: (1) type of sensory impairment (e.g., hypoesthesia, hyperesthesia, paresthesia, or anesthesia); (2) location of impairment (specific ICBN-innervated regions affected); (3) extent/area of impairment (measured as the involved surface area within each region); and (4) proportion of impairment (the percentage of patients with sensory impairment in each region and modality). These sensory outcomes are compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups.

Trial sites (2)

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