Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Breast Conserving Surgery for Breast Tumor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Tumor
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
- Last Updated
- 4 years ago
Overview
Brief Summary
The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance.
Detailed Description
A total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent US-guided percutaneous MWA and breast conserving surgery treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.
Investigators
Ping Liang
Director, Clinical Professor
Chinese PLA General Hospital
Eligibility Criteria
Inclusion Criteria
- •with invasive ductal carcinoma of the breast according to core-needle
- •tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 )
- •located at least 10 mm from the skin surface and chest wall.
Exclusion Criteria
- •women who were pregnant or breastfeeding
- •radiologic suspicion of multifocality or extensive intraductal carcinoma
- •histologic diagnosis of lobular carcinoma
- •neoadjuvant therapy
- •previous surgery or radiation therapy of the ipsilateral breast.
Outcomes
Primary Outcomes
overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
Time Frame: 5 years
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
Time Frame: 3 years
Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
Secondary Outcomes
- local tumor progress：Defined as the proportion of patients with active tumor at the edge of the treatment ：Defined as the proportion of patients with active tumor at the edge of the treatment(5 years)
- metastasis：Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient(5 years)
- complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient(5 years)