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Stereotactic Directional Vacuum-Assisted Breast Biopsy

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01957020
Collaborator
(none)
130
Enrollment
7
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    130 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Diagnostic Accuracy of Stereotactic Directional Vacuum-Assisted Breast Biopsy
    Study Start Date :
    Jun 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2008
    Actual Study Completion Date :
    Jan 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis [up to 5 years ( July 2008 to June 2013)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT01957020
    Other Study ID Numbers:
    • 200806017R
    First Posted:
    Oct 8, 2013
    Last Update Posted:
    Oct 16, 2013
    Last Verified:
    Oct 1, 2013

    Study Results

    No Results Posted as of Oct 16, 2013