Breast Tumor, Cryoablation, Microwave Ablation
Conditions
Brief summary
The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and cryoablation of benign and malignant breast lesion under ultrasound (US) guidance.
Detailed description
A total of more than 200 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in two centers of China will be recruited in this study and underwent US-guided percutaneous MWA and cryoablation 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 and cryoablation are both thermal ablation techniques for minimally invasive treatment of breast tumor. They are performed percutaneously by ultrasound guidance.The tumor can be completely killed without injurying adjacent tissue.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* (a) the breast tumor obtained the pathological diagnosis by using core-needle biopsy; (b) for the benign lesion, continually increasing during a half year followup,with the symptoms of local pain, discomfortable or compression considered probably relating to the mass of breast; the patient with evidently psychological pressure due to the occurrence of the BBL despite clearly benignancy on imaging; (c) for the malignant lesion, with the tumor size smaller than 2cm and without other metastasis.
Exclusion criteria
* (a) the patients who were pregnant or breast-feeding; (b) the patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction; (c) the patients during menstrual period; (d) the patients referring to other therapies including surgical excision and vacuum-assisted biopsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| volume reduce rate | 3 year | divide the volume of ablation zone by unablated lesion volume |
| overall survival | 5 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local tumor progress | 5 year | any nodular occurence adjacent to the ablation zone during the follow-up |
| metastasis | 5 year | any nodular occurence keeping away from the ablation zone during the follow-up |
| complication | 5 year | numbers of participants with side effect and major complications |
Countries
China
Contacts
Primary ContactJie Yu, Dr.
Outcome results
None listed