An interventional study of microwave ablation in Breast Tumor, Microwave Ablation and Cryoablation, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
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.
Also known as: cryoablation
volume reduce rate
divide the volume of ablation zone by unablated lesion volume
Time frame: 3 year
overall survival
Time frame: 5 year
local tumor progress
any nodular occurence adjacent to the ablation zone during the follow-up
Time frame: 5 year
metastasis
any nodular occurence keeping away from the ablation zone during the follow-up
Time frame: 5 year
complication
numbers of participants with side effect and major complications
Time frame: 5 year
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital