Breast Cancer
Conditions
Interventions
Experimental Group:ES-Assisted Breast-Conserving Surgery Group (ES Interpretation: Conducted by a breast surgeon and a pathologist, both of whom have received at least one hour of ES training before p
Control Group:Frozen Pathology Interpretation Group
Gold Standard Group:Gold Standard Interpretation: Conducted by a tumor cytology pathologist, using paraffin pathology interpretation as the gold standard.
Sponsors
Nanchang People's Hospital (Nanchang Third Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: a) Age between 18 and 70 years; b) Early-stage breast cancer with tumor size less than 5 cm, c N 0-1; c) No involvement of skin, subcutaneous tissue, pectoralis major muscle, or nipple-areola complex; d) No evidence of distant metastasis on clinical or imaging studies; e) Voluntary signing of informed consent by the participant or exemption from signing after approval by the ethics committee.
Exclusion criteria
Exclusion criteria: a) Inflammatory breast cancer; b) Presence of chest wall or skin involvement, locally advanced breast cancer; c) Extensive axillary lymph node metastasis (stage IIIB and above); d) Severe comorbidities (e.g., organ dysfunction, immunodeficiency) or poor general condition; e) Inability to undergo general anesthesia or surgery; f) Participation in other clinical studies that may interfere with this trial; g) Inability to obtain satisfactory specimens for both intraoperative frozen pathology and paraffin pathology; h) Inability to obtain a paraffin pathology report.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy: Using paraffin pathology as the gold standard, evaluate the sensitivity and specificity of ES detection compared to rapid frozen pathology interpretation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Consistency Rate: Evaluate the consistency between pathologists and clinical doctors in interpreting ES results;Usability Score: Assess the usability and image satisfaction of the ES through questionnaires completed by pathologists and surgeons;Learning Curve Index: Record and analyze the time taken and accuracy of interpretation by surgeons using the ES; | — |
Countries
China
Contacts
Public ContactZhihua Li
Nanchang People's Hospital (Nanchang Third Hospital)
Outcome results
None listed