Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03868475

Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast Lesions

Efficacy, Safety, Cosmesis and Patient Satisfaction With Vacuum-Assisted Percutaneous Excision (VAPE) Compared With Standard Surgical Excision (X) of Non-malignant, Borderline or High-risk Breast Lesions: A Randomized Controlled Trial

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREVacuum-assisted percutaneous excisionThe intervention group will undergo the vacuum assisted percutaneous excision (VAPE). All VAPE procedures will be performed on a digital supine table using the ATEC© Breast Biopsy System hand piece (Hologic) with a 9-gauge needle and a 10 or 20 mm aperture providing 6-mmHg of suction strength to completely excise the breast lesion.
PROCEDUREOpen surgical excisionThe control group will undergo standard open surgical excision of the breast lesion. This will be done in the operating room using preoperative image-guided localization with radioactive seed (I-125) or in the procedure room of the Breast Care Centre if appropriate (i.e. lesion is palpable and localization is not required).

Timeline

Start date
2025-01-01
Primary completion
2026-01-01
Completion
2028-01-01
First posted
2019-03-11
Last updated
2026-03-09

Source: ClinicalTrials.gov record NCT03868475. Inclusion in this directory is not an endorsement.