Comparison of Microwave Ablation With Cryoablation for Breast Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Cryoablation for Breast Tumor

Conditions
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Breast Tumor, Microwave Ablation, Cryoablation

Intervention / Treatment
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* Procedure: microwave ablation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microwave ablation<br>Microwave ablation（MWA）refers to all electromagnetic methods of inducing tumor destruction by using devices with frequencies greater than or equal to 900MHz. The rotation of dipole molecules accounts for most of the heat generated during MWA. Water molecules as dipoles attempt to continuously reorient at the same rate in microwave's oscillating electric field. As a result of microwave transmission, the water molecules flip back and forth billions of times a second. The vigorous movement of water molecules produce friction and heat, thus inducing cellular death via coagulation necrosis. The microwave unit (KY-2000, Kangyou Medical, Nanjing, China) is capable of producing 100 Watts of power at 2450 MHz.The needle antenna has a diameter of 1.6 mm (16G) and a length of 10 cm. The active tip length is 3mm and 5mm. | Procedure: microwave ablation<br>* 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.<br>* Other names: cryoablation;|
| Active Comparator: cryoablation<br>Clinically, cryosurgery is accomplished by placing a cryoprobe(up to 3.5 mm) through a stab incision into the tumor under ultrasound guidance.Liquid nitrogen is utilized under low operating pressure as cryogen which is controlled by the computer modulated cryogen regulator. The cryoprobe achieves rapid freezing by means of an active freeze zone at its distal tip. | Procedure: microwave ablation<br>* 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.<br>* Other names: cryoablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume reduce rate | divide the volume of ablation zone by unablated lesion volume | 3 year | 
| overall survival |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local tumor progress | any nodular occurence adjacent to the ablation zone during the follow-up | 5 year | 
| metastasis | any nodular occurence keeping away from the ablation zone during the follow-up | 5 year | 
| complication | numbers of participants with side effect and major complications | 5 year |