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Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions

NCT ID: NCT02860104

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2018-12-31

Brief Summary

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The investigators will perform this study to prospectively analyse the clinical outcome after percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound (US) guidance.

Detailed Description

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A total of more than 500 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in seven centers of China will be recruited in this study and underwent US-guided percutaneous MWA 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 measured and analyzed.

Conditions

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Neoplasm of Breast

Keywords

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microwave ablation breast multicenter

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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microwave ablation

microwave ablation

Group Type OTHER

microwave ablation

Intervention Type DEVICE

ultrasound guided percutaneous microwave ablation for breast lesions

Interventions

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microwave ablation

ultrasound guided percutaneous microwave ablation for breast lesions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* breast lesion proved by using core-needle biopsy;
* for benign lesions,lesion 1.0 cm or larger in greatest diameter and continually increasing during a half year follow-up; for malignant ones, lesion size 2cm or smaller;
* distance of at least 1.0cm to papilla with the patients supine;
* the symptoms of local pain, discomfortable or compression considered probably relating to the lesion of breast;
* the patient with evidently psychological pressure due to the occurrence of the lesion;
* patients unwilling or refused to receive other treatment and presence of an appropriate route for percutaneous puncture under US guidance.

Exclusion Criteria

* patients who were pregnant or breast-feeding;
* patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction;
* patients during menstrual period;
* patients who wanted to undergo other therapies including surgical excision and vacuum-assisted biopsy.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ping Liang

Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping Liang, Doctor

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Yu, Doctor

Role: CONTACT

Phone: 8610-66939530

Email: [email protected]

Facility Contacts

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Jie Yu, Doctor

Role: primary

References

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Yang Q, Li H, Chen BH, He GZ, Wu XP, Wang LX, Wu H, Dou JP, Han ZY, Zhang J, Yu XL, Yu J, Liang P. Ultrasound-guided percutaneous microwave ablation for 755 benign breast lesions: a prospective multicenter study. Eur Radiol. 2020 Sep;30(9):5029-5038. doi: 10.1007/s00330-020-06868-9. Epub 2020 Apr 30.

Reference Type DERIVED
PMID: 32356159 (View on PubMed)

Yu J, Wu H, Meng XW, Mu MJ, Dou JP, Ahmed M, Liang P. Ultrasound-guided percutaneous microwave ablation of central intraductal papilloma: a prospective pilot study. Int J Hyperthermia. 2019;36(1):606-612. doi: 10.1080/02656736.2019.1619849.

Reference Type DERIVED
PMID: 31179781 (View on PubMed)

Other Identifiers

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939530lp

Identifier Type: -

Identifier Source: org_study_id