Prospectively Multi-center Study Of Ultrasound-guided Microwave Ablation For Breast Tumours

Purpose1.Conducting a prospective multi-center study to evaluate the the safety and efficacy of ultrasound-guided microwave ablation for benign breast tumors by large medical samples and providing more comprehensive and reliable high level evidence.2.To summarize the clinical experience of US-guided percutaneous microwave ablation for breast intraductal papilloma and explore its clinical application value in the treatment of intraductal papilloma.3.To evaluate the clinic outcomes of percutaneous US-guided MWA of microwave ablation for breast cancer and analyze its safety and feasibility.Methods1.From November 2013 to December 2017,428 patients with 927 benign breast lesions were treated in 5 hospitals in China with US-guided percutaneous MWA.The mean diameter of lesions was 1.4±0.6cm(range:0.3-6.0 cm)The patients were assessed with unified standards.The size of the lesion,blood flow and ablation range were observed by both US and CEUS,and technique effectiveness rate(TER)?volume reduction rate(VRR)was calculated.Some subjective evaluation indexes such as beauty satisfaction,minimal invasion satisfaction,clinical symptoms were quantified evaluated and complications was recored.2.From October 2014 to December 2017,11 patients with 11 breast intraductal papilloma were treated with US-guided percutaneous MWA in our department.The average diameter was 1.4±0.4cm(0.7-2.0cm).Preoperative pathology was evaluated.During the ablation,the lesions were monitored and controlled.To protect the papilla,water isolation technique was applied meanwhile.The size of the lesion,blood flow and ablation range were observed by both US,CEUS and enhanced MRI.Technique effectiveness rate(TER)?volume reduction rate(VRR)was calculated.clinical symptoms and complications was recored.Choosing the eligible patients is an important part to achieve satisfying outcomes.3.From October 2014 to December 2017,18 females with 18 malignant lesions were treated in two hospitals with US-guided percutaneous MWA.The therapeutic apparatus of KY-2000 type(frequency 2450 MHZ)and water-cooled microwave antenna was applied during the ablation.The average diameter was 3.0±1.2cm(0.7-5.3cm).And the lesions were ablated expandly.Six of these cases were combined with axillary lymphatic metastasis in armpit,including 2 patients with other organ metastasis.Results1.There were 927 lesions in 428 patients in 5 hospitals,and the TER of US and CEUS was 94.2%(874/927),while MRI showed an effective rate of 92.7%(860/927).The lesion volumes were statistically different from the volumes before ablation(P<0.001),and the reduction rate was 83.20%±59.1%during the median follow-up period of 8months.After the operation,the immediate post-operative pain score was 0.57 ±0.5(VAS score),As for the complications,one case of abscess and two cases of fat liquefaction.fIve cases of skin burn,including one case of skin rupture in the areolar area,90.8%(389/428)patients were very satisfied with the aesthetic appearance of the postoperative breast.2.Eleven patients were with 11 central intraductal papilloma without atypical hyperplasia,which were proved by biopsy.During the follow-up of 6 months,the VRR was 72.6%,and the difference was statistically significant between preoperative volume and postoperative volume(P<0.05).The symptoms disappeared after treatment in 5 cases with nipple discharge before the treatment..90.90%(10/11)patients were very satisfied with beauty.Most patients had mild fever and pain in the ablation zone during the treatment without severe complications such as nipple injury.And the immediate post-operative pain score was 0.68 + 0.4(VAS score),3.All 18 cases of breast cancer were treated with US-guided microwave ablation,the tumors were achieve completely 100%(18/18)ablation without residual tumor.If the patient with lymphatic metastasis,the lymph node was treated meanwhile.All patients were treated with microwave ablation once.The average diameter of the tumor was 3.0±1.2cm(0.7-5.3 cm).During median follow-up of 14 months,one patient was diagnosed clinical recurrence followed for 3 years,no other local recurrence or distant metastasis was happened.The tolerance of microwave ablation was good,the pain was mild with the score of 0.81 ± 0.13(VAS score).Although all 18 patients were treated with expanded ablation,there was no major complication.Conclusions1.Ultrasound-guided percutaneous microwave ablation for breast benign lesions has curative effect,less complications,high security and satisfied beauty outcomes,2.Ultrasound-guided percutaneous microwave ablation for isolation intraductal papilloma has good curative effect.The tumors achieve completely elimination without nipple injury and shape change.3.Ultrasound-guided percutaneous microwave ablation is a safe and effective therapy in treatment of breast cancer.