Stereotactic Directional Vacuum-Assisted Breast Biopsy

The Diagnostic Accuracy of Stereotactic Directional Vacuum-Assisted Breast Biopsy

Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy procedure for suspicious findings on mammograms in Western countries for more than 10 years [1-3], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike and was reported to feature a high sensitivity, very low delayed false-negative rate (less than 2%)[4,5]. Moreover, it causes less scarring, less psychologic stress to patients and less morbidity compared with needle localization excisional biopsy [6,7]. However, its sensitivity, accuracy has seldom been reported in Asian countries [8] , since most Asian women have different breast parenchyma pattern, different breast cancer prevalence. Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an effective alternative to NLOC excisional biopsy in our country.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Female; Adult Patients; Stereotactic Directional Vacuum-assisted Breast Biopsy

• Study Type: Observational
• Enrollment (Actual): 130

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

asymptomatic women with mammographic screening, and with suspicious findings on mammography.

Description

Inclusion Criteria:

• The indication for ST DVAB was lesions with suspicious nature for malignancy seen on mammograms which biopsy is necessitated for tissue proof, or probably benign or benign appearing lesions seen on mammograms but patients or clinicians requested biopsy

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis	the aforementioned outcome measure-"sensitivity"- is the probability of the stereotactic vaccum assisted breast biopsy can correctly diagnose the breast cancer. And according to statistical definition, it is defined as- for those breast cancer cases, how many of them can be correctly diagnosed by stereotactic breast biopsy.	up to 5 years ( July 2008 to June 2013)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 30, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 13, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 200806017R