Is there a difference between rates of re-biopsy when an initial ultrasound-guided breast biopsy is performed with a core-needle vs. vacuum-assisted technique?
Benign, malignant, and high risk diagnoses are reported; and
Re-biopsies and the reasons for them are reported
Condition or domain being studied
Ultrasound-guided needle breast biopsy methods.
Participants/ population
Human females undergoing ultrasound-guided needle breast biopsy.
Intervention(s), exposure(s)
Ultrasound-guided 14ga. core-needle biopsy vs. ultrasound-guided vacuum-assisted needle biopsy (11-8ga.) for BI-RADS 3-5 breast lesions.
Comparator(s)/ control
Two different biopsy techniques, CNB vs. VAB.
Context
Sufficient study detail must be reported to allow an assessment of both the primary and secondary outcomes.
Outcome(s)
Primary outcomes
Rates of re-biopsy after ultrasound-guided needle biopsy.
We are looking at simple reported rates of re-biopsy at any time after the initial ultrasound-guided biopsy
Secondary outcomes
Reasons for any reported re-biopsies re-biopsies.
Methods of any reported re-biopsies.
Re-biopsies can occur if the initial biopsy is indeterminate or if a benign lesion progresses after initial biopsy.
Data extraction, (selection and coding)
Data will include:
Benign, malignant and high risk initial biopsy diagnoses;
Rates of re-biopsy;
Reasons for re-biopsy (discordant finding, high-risk lesion, progression); and
Method of re-biopsy (surgical or repeat needle).
Risk of bias (quality) assessment
Each study included in the analysis will be reviewed for completeness of reporting and the quality of the study (prospective study, prospective series, retrospective study, retrospective series). These results will be reported
A sensitivity analysis will be performed after the data are synthesized.
Strategy for data synthesis
A metanalysis of rates will be performed using the Freeman-Tukey arcsine method for normalization of combined proportions.
Analysis of subgroups or subsets
Core-needle biopsies and vacuum-assiosted biopsies will be evaluated as separate subsets.
Dissemination plans
Journal publication
Contact details for further information
Ian Grady
1335 Buenaventura Blvd, Suite 204
Redding, CA 96001
USA
igrady@breastpractice.com
Organisational affiliation of the review
North Valley Breast Clinic
www.breastpractice.com
Review team
Dr Ian Grady, North Valley Breast Clinix
Anticipated or actual start date
15 April 2011
Anticipated completion date
30 November 2012
Funding sources/sponsors
An unrestricted research grant:
Devicore, Inc.
Cincinnati, Ohio, USA
Conflicts of interest
None known
Language
English
Country
United States of America
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Biopsy, Needle; Breast; Female; Humans; Vacuum
Date of registration in PROSPERO
10 October 2012
Date of publication of this revision
08 April 2013
Stage of review at time of this submission
Started
Completed
Preliminary searches
Yes
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Data extraction
Risk of bias (quality) assessment
Data analysis
Prospective meta-analysis
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.
