Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions
Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions
This randomized controlled trial compares vacuum-assisted percutaneous excision to open
 standard surgical excision in women who have high-risk or borderline, non-malignant breast
 lesions with respect to efficacy, safety, cosmesis and patient satisfaction.
In women diagnosed with high-risk or borderline, non-malignant breast lesions, is
 vacuum-assisted percutaneous excision (VAPE) comparable to open standard surgical excision
 with respect to efficacy, safety, cosmesis and patient satisfaction?

 With the increase in breast imaging for screening there has been corresponding rise in
 detection of high-risk/borderline, non-malignant breast lesions that require surgical
 excision to confirm diagnosis and rule out underlying malignancy. Image-guided
 vacuum-assisted percutaneous excision (VAPE) could offer an alternative to standard open
 surgical excision for complete excision of these lesions with a possible improvement in
 patient satisfaction and cosmetic outcomes and decreased complications.

 In this single-centre, non-inferiority designed prospective randomized, open label controlled
 trial, women over 18 years who are found to have a borderline or high-risk, non-malignant
 breast lesions on core needle biopsy will be considered eligible. Exclusion criteria will be
 women with a greater than 25% lifetime risk of breast cancer, patients whose pathology and
 imaging are discordant, and those with extensive calcifications extending over 2cm, a mass
 larger than 2 cm, or lesions with high-risk features. Informed consent will be obtained and
 patients will be randomized to standard surgical excision or VAPE. They will then be followed
 with imaging as appropriate.

 The primary outcome measure is the incidence of complete removal of the lesion. The secondary
 outcome measures are patient satisfaction, cosmetic outcomes and complications such as
 bleeding and infection.

 This trial is the first randomized controlled trial to investigate the role of VAPE compared
 to standard surgical excision as a means of completely excising borderline or high-risk
 breast, non-malignant breast lesions. The investigators hypothesize that VAPE will show
 comparable efficacy and may even have improved safety, cosmesis and patient satisfaction.
Inclusion Criteria:

 -  Women over age 18 with a core biopsy proven borderline or high-risk breast lesion that
 requires further excision for management based on the surgeon's assessment

 -  Informed consent must be obtained.

 Exclusion Criteria:

 -  Women who are considered high-risk based on a greater than 25% lifetime risk of breast
 cancer as per the IBIS (International Breast Cancer Intervention Study) Breast Cancer
 Risk Evaluation Tool

 -  Pathology that is felt to be discordant with imaging

 -  Extensive calcifications extending more than 20 mm and/or masses greater than 30 mm

 -  The following lesions will be excluded based on their increased risk of upstaging;
 lesions (other than fibroadenomas, phyllodes and papillomas) that are associated with
 a palpable mass, ADH (atypical ductal hyperplasia) with high-risk features (ADH with
 zonal necrosis, significant cytological atypia or more than 2 foci), LCIS (lobular
 carcinoma in situ) with high-risk features (associated with ADH, pleomorphic LCIS,
 zonal necrosis and > 4 foci) or discordant with imaging, papilloma with atypia, and
 spindle cell lesion (especially if there is atypia).

 -  Lesions that are suspicious for borderline or malignant Phyllodes, DCIS (ductal
 carcinoma in situ), invasive mammary carcinoma, or encapsulated papillary carcinoma

 -  Any lesion that either the radiologist, pathologist or surgeon feels is not amenable
 to VAPE or surgical excision