14 g vs. 16 g in Breast Biopsy

N/ACompletedNCT03212040

University Hospital Tuebingen186 enrolled

Overview

Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

186

Conditions

Breast Biopsy

Interventions

needle biopsyDIAGNOSTIC_TEST

breast biopsy using different needle gauges

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Minimum age of 18 years * Informed consent available * Palpable and non-palpable breast findings * Tumor size 5-20 mm * Findings of sonographic BI-RADS® classification 2-5. * Guideline-oriented indication for bioptic clarification Exclusion Criteria: * No reliable sonographic demarcation of the finding * Pregnancy

Locations (1)

Department of Women's Health

Tübingen, Germany

Outcomes

Primary Outcomes

Diagnostic accuracy

* Diagnostic aggreement (representativity) with definitive histology of core needle specimen and of surgical specimen * Additive diagnostic aggreement (representativity) with definitive histology of core needle specimen and with histology of surgical specimen, with 1 to 5 passes of core needle biopsy * Additive diagnostic accuracy to achieve a high (\>=99%) diagnostic yield, with 1-5 passes of core needle biopsy

Time frame: 1 year

Diagnostic quality

* Diagnostic quality of specimen to achieve an accurate histological diagnosis * Diagnostic quality of specimen to achieve an accurate histological diagnosis, with 1 to 5 passes of core needle biopsy * Additive diagnostic quality to achieve a high (\>=99%) diagnostic yield, with 1-5 passes of core needle biopsy

Time frame: 1 year

Secondary Outcomes

Pain related to the biopsy procedure

Subjective pain perception measured visual analog scale

Time frame: 1 year

Duration time of the biopsy procedure

Time frame: 1 year

Data from ClinicalTrials.gov

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