A Prospective, Single-center, Double-arm Clinical Study to Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection Combined With Immediate Breast Reconstruction in Breast Cancer

The First Affiliated Hospital with Nanjing Medical University0 sites40 target enrollmentDecember 1, 2024

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Enrollment: 40
Primary Endpoint: Local recurrence free survival rate
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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 the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, double-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection combined with immediate breast reconstruction in breast cancer.

Registry

clinicaltrials.gov

Start Date

December 1, 2024

End Date

December 31, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 (Endoscopic Instrument Control System SP1000) for subcutaneous gland resection, sentinel lymph node biopsy, axillary lymph node dissection and immediate breast reconstruction;

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.