Status:
NOT_YET_RECRUITING
To Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06561646
Start Date
August 21 2024
End Date
December 31 2028
Last Update
August 20 2024
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210009