14 g vs. 16 g in Breast Biopsy

Not Applicable

Completed

• Conditions: Breast Biopsy
• Interventions: Diagnostic Test: needle biopsy

• Registration Number: NCT03212040
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-05
• Primary Completion: 2013-02-18
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-11
• Study Completion: 2018-06-07
• Status Verified: 2019-02
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14 gauge needle biopsy	needle biopsy	breast biopsy will be performed with 14 gauge needle
16 gauge needle biopsy	needle biopsy	breast biopsy will be performed with 16 gauge needle

Primary Outcome Measures

Name	Time	Method
Diagnostic quality	1 year	* 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
Diagnostic accuracy	1 year	* 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

Secondary Outcome Measures

Name	Time	Method
Duration time of the biopsy procedure	1 year	Duration time of the biopsy procedure
Pain related to the biopsy procedure	1 year	Subjective pain perception measured visual analog scale

Trial Locations

Locations (1)

Department of Women's Health; 🇩🇪 Tübingen, Germany