To Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer

NCT06561646 | Not Yet Recruiting

• 1 other identifier: BC-Robot-20240810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Breast Cancer

Keywords

single-port robotic-assisted breast surgery

Outcome Measures

Primary Outcomes (1)

• Local recurrence free survival rate

  Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site.

  Ten years

Study Arms (1)

single-port robotic-assisted breast surgery

EXPERIMENTAL

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

Procedure: single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy; Procedure: single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection

Interventions

single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy PROCEDURE

the single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy in the management of breast cancer

single-port robotic-assisted breast surgery

single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection PROCEDURE

the single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection in the management of breast cancer

single-port robotic-assisted breast surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Central Study Contacts

Qiang Ding, Professor

CONTACT

+8613951731373; dingqiang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)