Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-sparing Matectomy With Reconstruction in Early-Stage Breast Cancer Patients

Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-Sparing Mastectomy With Reconstruction in Early-Stage Breast Cancer Patients: A Single-Center, Single-Arm, Prospective Interventional Clinical Trial

This study is testing a new, less invasive way to perform breast cancer surgery using a single-port robotic system (a robot-assisted surgical tool made in China, called the Shurui SR-ENS-600). The robot works through one small hidden incision (about 3-4 cm) in the armpit or under the breast fold, instead of multiple cuts or a large open wound.

We want to find out whether this robot-assisted surgery is safe and effective for women with early-stage breast cancer who need either:

Breast-conserving surgery (lumpectomy), or

Total removal of breast tissue with immediate reconstruction using a breast implant.

You may be able to join if you:

Are a woman aged 18-70 years;

Have been diagnosed with early-stage breast cancer (by biopsy);

Are suitable for either breast-conserving surgery or mastectomy with immediate implant reconstruction;

Are in good general health (able to tolerate surgery and anesthesia);

Are willing to receive the robotic surgery and complete the follow-up visits.

If you join, you will:

Receive the robotic surgery as your main treatment;

Stay in the hospital for a short period after surgery (about 1-7 days);

Come back for follow-up visits at 1, 3, 6, 12, and 24 months after surgery;

Be asked to complete a few simple questionnaires about your recovery, satisfaction with breast appearance, and quality of life.

Inclusion Criteria:

1. Female patients aged 18 to 80 years;

2. Histopathologically confirmed invasive breast cancer or ductal carcinoma in situ (DCIS);

3. Clinical stage I-II for breast-conserving surgery, or clinical stage I-III for subcutaneous mastectomy with immediate prosthetic reconstruction;

4. Planned to undergo breast-conserving surgery or subcutaneous mastectomy with immediate prosthetic reconstruction;

5. For breast-conserving surgery: maximum tumor diameter ≤ 3 cm, with a favorable tumor-to-breast volume ratio for breast conservation;

6. For subcutaneous mastectomy with immediate prosthetic reconstruction: willingness and appropriate indication for prosthetic reconstruction, with moderate breast volume;

7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;

8. American Society of Anesthesiologists (ASA) physical status classification I-III;

9. Adequate vital organ function meeting the following criteria:

   Hematology: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 90 × 10⁹/L, hemoglobin ≥ 90 g/L;

   Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5 × ULN;

   Renal function: creatinine ≤ 1.5 × ULN;

   Coagulation function: INR ≤ 1.5, APTT ≤ 1.5 × ULN;

10. Voluntary participation with written informed consent signed.

Exclusion Criteria:

1. Prior history of breast surgery (excluding biopsy procedures);
2. Prior history of chest wall radiotherapy;
3. Pregnant or lactating women;
4. Concurrent malignancy (excluding adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
5. Severe cardiopulmonary dysfunction precluding tolerance to general anesthesia;
6. Severe hepatic or renal insufficiency;
7. Coagulation disorders or ongoing anticoagulant therapy that cannot be discontinued;
8. Active infection, particularly in the breast region;
9. Allergy or intolerance to silicone implant materials (for patients undergoing prosthetic reconstruction);
10. Severe breast ptosis or excessively large breast volume (for patients undergoing prosthetic reconstruction);
11. Presence of any contraindication to surgery, or any condition that the investigator deems unsuitable for study participation.