A Comparative Study on the Accuracy and Safety of Robotic-Assisted Versus Endoscopic-Assisted Sentinel Lymph Node Biopsy in Patients With 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
- 150
- 试验地点
- 1
- 主要终点
- Accuracy Outcomes
研究概览
简要总结
This is a retrospective observational study comparing the accuracy and safety of robotic-assisted versus endoscopic-assisted sentinel lymph node biopsy (SLNB) in patients with breast cancer. The study aims to evaluate the detection accuracy, false-negative rate, and perioperative safety profile between the two minimally invasive techniques, as well as to assess postoperative complications, pain, upper limb function, quality of life, and 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.Accuracy-related outcomes: sentinel lymph node detection rate, number of sentinel lymph nodes identified, and false-negative rate, sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV). All accuracy metrics are calculated with reference to final axillary lymph node status confirmed by completion ALND or long-term clinical follow-up; 2.Safety-related outcomes: perioperative parameters including operative time, estimated blood loss, length of hospital stay, and duration of postoperative drainage; postoperative complications including but not limited to seroma, hematoma, wound infection, and lymphedema; 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; 3.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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 80 years;
- •Patients with pathologically confirmed breast cancer;
- •Patients with cN0 or pre-neoadjuvant therapy cN1 breast cancer who are planned to undergo sentinel lymph node biopsy (SLNB);
- •Patients who provide written informed consent;
- •Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1.
排除标准
- •Clinical nodal stage greater than cN1 or inflammatory breast cancer;
- •Prior history of ipsilateral axillary or breast surgery;
- •Presence of distant metastasis (Stage IV);
- •Allergy to indocyanine green (ICG) or carbon nanoparticles;
- •Patients with other malignant tumors or severe comorbidities that render them unable to tolerate surgery.
结局指标
主要结局
Accuracy Outcomes
时间窗: Perioperative, at final pathology after completion axillary lymph node dissection
Sentinel lymph node biopsy (SLNB) accuracy is comprehensively evaluated in patients undergoing robotic-assisted or endoscopic-assisted SLNB for breast cancer. The following accuracy metrics are assessed: (1) false-negative rate (calculated among patients with confirmed axillary lymph node metastasis, defined as the proportion of SLNB-negative patients who have positive non-sentinel nodes on completion axillary lymph node dissection); (2) sensitivity (the proportion of patients with axillary metastasis who have a positive SLNB); (3) specificity (the proportion of patients without axillary metastasis who have a negative SLNB); (4) negative predictive value (NPV); and (5) positive predictive value (PPV).
次要结局
- Sentinel Lymph Node Detection Rate(Perioperative, at final pathology)
- Number of Sentinel Lymph Nodes Identified Per Patient(Perioperative, at final pathology)
- 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(Intraoperative)
- Intraoperative Blood Loss(Intraoperative)
- Length of hospital stay(Perioperative)
- Duration of postoperative drainage(Perioperative)
研究者
haiyanli
Professor
Guangzhou Women and Children's Medical Center