A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Local recurrence free survival rate
研究概览
简要总结
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the abdominal endoscopic surgery system and evaluate the effectiveness and safety of the single-port robotic-assisted breast surgery in breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, aged 18-75 years old; The pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients;
- •Patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; Breast cancer patients with tumor node metastasis stage 0-III according to the 8th edition of the American Joint Commission on Cancer; Preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the Nipple Areolar Complex (NAC) is more than 1cm. The tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. The distance between the lesion and the skin should be at least 8-10 mm;
- •There is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex;
- •There are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery;
- •Preventive mastectomy (BRCA1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups);
- •Preoperative clinical manifestations and imaging data showed no distant metastasis;
- •No history of breast cancer or other serious underlying diseases in the past;
- •Karnofsky performance status score ≥ 70;
- •Eastern Cooperative Oncology Group score ≤ 2 ;
- •The surgical procedure includes a single-port robot (intraperitoneal endoscopic surgical system) for total mastectomy with preservation of the nipple and areola, sentinel lymph node biopsy, axillary lymph node dissection, and stage I breast prosthesis implantation;
- •Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up;
- •No swallowing difficulties; No shoulder joint movement disorders;
- •Complete clinical data.
排除标准
- •Male breast cancer or inflammatory breast cancer;
- •Metastatic breast cancer (stage IV); Tumor invasion of the skin, pectoralis major muscle, or NAC;
- •The clinical data is basically incomplete;
- •Previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital;
- •Bilateral breast cancer surgery;
- •Other surgical methods;
- •Preoperative distant metastasis or supraclavicular lymph node dissection;
- •Complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years;
- •The serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state;
- •Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.
研究组 & 干预措施
single-port robotic-assisted breast surgery
the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer; single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection
干预措施: single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy (Procedure)
single-port robotic-assisted breast surgery
the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer; single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection
干预措施: single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection (Procedure)
结局指标
主要结局
Local recurrence free survival rate
时间窗: Ten years
Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.
次要结局
未报告次要终点