Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Breast Conserving Surgery; Microwave Ablation; Breast Tumor

Treatments: Procedure: breast conserving surgery; Procedure: microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04626986

S2020-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

microwave ablation

Experimental group

Description:

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.

Treatment:

Procedure: microwave ablation

breast conserving surgery

Active Comparator group

Description:

Breast-conserving surgery refers to the removal of the primary tumor and adjacent breast tissue, supplemented by postoperative radiotherapy.Its principle is to remove the primary tumor completely while meet patient's cosmetic satisfaction.The combined treatment of early breast cancer with radiotherapy and chemotherapy is the same as radical surgery or modified radical surgery in terms of local and regional control rate and long-term survival rate. Breast conserving surgery and postoperative comprehensive treatment have become one of the main methods for the treatment of early breast cancer.

Treatment:

Procedure: breast conserving surgery