Breast Neoplasms
Conditions
Keywords
breast cancer, axillary lymph node dissection, intercostobrachial nerve, Robotic-Assisted Surgery, Endoscopic-Assisted Surgery, Quality of Life, sensory function
Brief 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.
Interventions
None listed
Sponsors
Guangzhou Women and Children's Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* pathologically confirmed breast cancer; * clinical N1-N3 stage or confirmation of lymph node metastasis by intraoperative frozen pathology; * Enlarged lymph nodes without significant adhesion to the axillary vessels or nerves; * Ability to comprehend the research questions; * Provision of informed consent and cooperation with the investigation; * No history or current diagnosis of mental illness or impaired consciousness; * ECOG PS 0-1.
Exclusion criteria
* Patients without lymph node metastasis; * Patients who refuse surgery; * Breast cancer patients with cognitive impairment, altered mental status, or inability to clearly express their feelings; * Critically ill patients; * Patients with other malignant tumors or severe medical conditions that render them unable to tolerate surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessed by Cancer Therapy - Breast + 4 | At postoperative follow-up visits (1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability) | Health-related quality of life is evaluated using the Functional Assessment of Cancer Therapy - Breast + 4 (FACT B+4) questionnaire, which assesses physical, social, emotional, and functional well-being, with additional breast cancer-specific concerns. |
| Upper Limb Function Assessed by Disabilities of the Arm, Shoulder and Hand Scores | At postoperative follow-up visits (1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability) | Upper limb function is assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, which evaluates the ability to perform daily activities and the severity of upper extremity symptoms. Scores are compared between the robotic-assisted and endoscopic-assisted groups. |
| Postoperative Complications | Within 30 days post-surgery and at long-term follow-up assessments | The incidence of postoperative complications is compared between the robotic-assisted and endoscopic-assisted groups, including but not limited to: seroma, hematoma, wound infection, surgical site infection, lymphedema of the ipsilateral upper extremity, shoulder dysfunction, and other procedure-related adverse events. All complications are graded according to the Clavien-Dindo classification system. |
| Recurrence and Metastasis Events | Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records | The incidence of axillary recurrence, locoregional recurrence, and distant metastasis is compared between the robotic-assisted and endoscopic-assisted ALND groups, with all events confirmed by histopathological or radiological evidence. |
| Survival Outcomes | Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records | Disease-free survival (DFS), defined as time from surgery to first recurrence, metastasis, or death, and overall survival (OS), defined as time from surgery to death from any cause, are compared between the two groups. |
| Operative Time | During surgery, recorded in the operative note | Operative time (minutes) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups. |
| Intraoperative Blood Loss | During surgery, recorded in the operative note | Intraoperative Blood Loss(mL) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups. |
| The number of Lymph Nodes Dissected | During surgery, recorded in the operative note | The number of lymph nodes dissected is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups. |
| Postoperative Recovery Parameters | During index hospitalization and within 30 days post-surgery | Length of hospital stay (days) and duration of postoperative drainage (days) are compared between the robotic-assisted and endoscopic-assisted groups. |
| Intercostobrachial Nerve Identification and Preservation | During surgery, recorded in the operative note | The number of intercostobrachial nerve identified, the number of intercostobrachial nerve preserved, and intercostobrachial nerve grading (based on intraoperative anatomical classification) are compared between the robotic-assisted and endoscopic-assisted groups. |
Countries
China
Outcome results
None listed