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NCT07781163

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

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-12-30

Completion Date

2026-12-30

Last Updated

2026-08-24

Healthy Volunteers

Conditions

Breast Cancer

Interventions

PROCEDURE

single-port robot-assisted surgery

All enrolled participants will receive single-port robot-assisted endoscopic breast cancer surgery. Patient will receive either breast-conserving surgery (BCS) or nipple-sparing mastectomy with immediate prosthetic reconstruction depending on the tumor burden.

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.