A Retrospective Study Comparing the Safety and Efficacy of Robotic-Assisted Versus Endoscopic-Assisted Axillary Lymph Node Dissection in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Incidence of Sensory Impairment in Intercostobrachial Nerve Innervated Regions
研究概览
简要总结
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:
- 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;
- 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;
- Postoperative complications: including but not limited to seroma, hematoma, wound infection, lymphedema, and shoulder dysfunction;
- 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;
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Sensory Impairment in Intercostobrachial Nerve Innervated Regions
时间窗: 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.
次要结局
- 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))
- 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))
- Postoperative Complications(Within 30 days post-surgery and at long-term follow-up assessments)
- Recurrence and Metastasis Events(Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records)
- Survival Outcomes(Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records)
- Operative Time(During surgery, recorded in the operative note)
- Intraoperative Blood Loss(During surgery, recorded in the operative note)
- The number of Lymph Nodes Dissected(During surgery, recorded in the operative note)
- Postoperative Recovery Parameters(During index hospitalization and within 30 days post-surgery)
- Intercostobrachial Nerve Identification and Preservation(During surgery, recorded in the operative note)
研究者
haiyanli
Professor
Guangzhou Women and Children's Medical Center