Breast Conserving Surgery, Breast Tumor, Microwave Ablation
Conditions
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.
Interventions
PROCEDUREmicrowave ablation
Microwave ablation has the advantages of aesthetics, precise positioning, minimally invasive and painless for patients with early breast cancer.The tumor can be completely killed without injurying adjacent tissue. Some studies have suggested MWA is a safe and effective therapy for the treatment of breast cancer.
PROCEDUREbreast conserving surgery
The treatment of early-stage breast cancer tends to be less-invasive including less morbidity, shorter hospitalization, and improved cosmetic results. Many reports have concluded that there was no difference between breast-conserving surgery and the traditional radical mastectomy for early stage breast cancer in time to distant metastases or overall survival, so breast-conserving surgery is becoming an alternative treatment for early-stage breast cancer.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. women, 2. with invasive ductal carcinoma of the breast according to core-needle 3. tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 ) 4. located at least 10 mm from the skin surface and chest wall.
Exclusion criteria
1. men 2. women who were pregnant or breastfeeding 3. radiologic suspicion of multifocality or extensive intraductal carcinoma 4. histologic diagnosis of lobular carcinoma 5. neoadjuvant therapy 6. previous surgery or radiation therapy of the ipsilateral breast.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death) | 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） | 3 years | Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Defined as the proportion of patients with active tumor at the edge of the treatment area during follow-up after the tumor was completely treated |
| 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 | 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 |
| 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 | Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient |
Countries
China
Contacts
Primary ContactJie Yu, Dr.
Outcome results
None listed