Download PDF
Ultraschall Med 2020; 41(05): 534-543
DOI: 10.1055/a-1014-2628
Original Article

Percutaneous Ultrasound-Guided Core Needle Biopsy: Comparison of 16-Gauge versus 14-Gauge Needle and the Effect of Coaxial Guidance in 1065 Breast Biopsies – A Prospective Randomized Clinical Noninferiority Trial

Perkutane ultraschallgestützte Stanzbiopsie: Vergleich von 16- und 14-Gauche-Nadel und Einfluss der koaxialen Führung bei 1065 Brustbiopsien – Eine prospektiv randomisierte klinische Nichtunterlegenheitsstudie
Ines Gruber‡
1   Department of Women’s Health, University of Tübingen, Germany
,
Ernst Oberlechner‡
1   Department of Women’s Health, University of Tübingen, Germany
,
Kerstin Heck
2   Frauenklinik, Klinikum Stuttgart Olgahospital Frauenklinik, Stuttgart, Germany
,
Uta Hoopmann
1   Department of Women’s Health, University of Tübingen, Germany
,
Bettina Böer
1   Department of Women’s Health, University of Tübingen, Germany
,
Regina Fugunt
1   Department of Women’s Health, University of Tübingen, Germany
,
Christian Gall
1   Department of Women’s Health, University of Tübingen, Germany
,
Andreas D. Hartkopf
1   Department of Women’s Health, University of Tübingen, Germany
,
Gisela Helms
1   Department of Women’s Health, University of Tübingen, Germany
,
Sascha M. Hoffmann
1   Department of Women’s Health, University of Tübingen, Germany
,
Claudia Ott
1   Department of Women’s Health, University of Tübingen, Germany
,
Carmen Röhm
1   Department of Women’s Health, University of Tübingen, Germany
,
Annette Stäbler
3   Institute of Pathology and Neuropathology, University of Tübingen, Germany
,
Diethelm Wallwiener
1   Department of Women’s Health, University of Tübingen, Germany
,
Sara Y. Brucker
1   Department of Women’s Health, University of Tübingen, Germany
,
Markus Hahn
1   Department of Women’s Health, University of Tübingen, Germany
› Author Affiliations
› Further Information
Also available at
    Permissions and Reprints

Abstract

Purpose Ultrasound-guided core needle biopsy (CNB) is considered the standard assessment to diagnose sonographically visible suspicious breast mass lesions. Based on nonrandomized trials, the current German guidelines recommend at least three cylinders with ≤ 14-gauge needle biopsy. However, no recommendation is made as to how many specimens are needed with a smaller needle size, such as 16-gauge, or if biopsy with coaxial guidance improves diagnostic accuracy and quality. Therefore, in a prospective monocentric unblinded randomized controlled clinical noninferiority trial, the diagnostic accuracy of 16-gauge versus 14-gauge core needle biopsy, with and without coaxial guidance, was evaluated.

Materials and Methods 1065 breast biopsies were included in order to analyze the number of core samples necessary to obtain an appropriate rate of diagnostic quality adequate for histological evaluation, and to achieve high diagnostic accuracy and diagnostic yield. Histological results were verified by surgery or long-term follow-up of at least two years up to five years.

Results In order to obtain an additive diagnostic accuracy of > 99 %, a minimum of two cylinders with 14-gauge biopsy were required. The diagnostic accuracy and the diagnostic quality of 14-gauge biopsy were not affected by the coaxial technique. When performing a 16-gauge biopsy, five cylinders were required to achieve an additive diagnostic accuracy of > 99 %. Without coaxial guidance, 16-gauge CNB required at least three samples, whereas five needle passes with coaxial-guided 16-gauge biopsy were needed.

Conclusion The diagnostic accuracy and quality of ultrasound-guided 16-gauge core needle biopsy were inferior to the 14-gauge needle size, regardless of the use of a coaxial technique.

Zusammenfassung

Ziel Die ultraschallgestützte Stanzbiopsie (CNB) gilt als Standardbewertung für die Diagnose sonografisch nachweisbarer verdächtiger Brustläsionen. Basierend auf nichtrandomisierten Studien empfehlen die aktuellen deutschen Richtlinien die Biopsie von mindestens 3 Zylindern mit ≤ 14-Gauche (G)-Nadel. Es wird jedoch keine Empfehlung abgegeben, wie viele Proben bei kleinerer Nadelstärke von z. B. 16-G benötigt werden, oder ob die koaxiale Führung die diagnostische Treffsicherheit und Qualität verbessert. Daher wurde in einer prospektiven, monozentrischen, nicht verblindeten, randomisierten, kontrollierten klinischen Nichtunterlegenheitsstudie die diagnostische Treffsicherheit der Stanzbiopsie mit 16-G-versus 14-G-Nadel mit und ohne Koaxialführung bewertet.

Material und Methoden 1065 Brustbiopsien wurden aufgenommen, um die Anzahl der erforderlichen Stanzproben zu analysieren, um eine entsprechende diagnostische Qualität zu erhalten, die für die histologische Beurteilung ausreicht und um eine hohe diagnostische Genauigkeit und Ausbeute zu erreichen. Die histologischen Ergebnisse wurden durch eine Operation oder eine Langzeitbeobachtung von mindestens 2 bis zu 5 Jahren bestätigt.

Ergebnisse Um eine additive diagnostische Genauigkeit von > 99 % zu erreichen, waren mindestens 2 Zylinder mit 14-G-Biopsie erforderlich. Die diagnostische Genauigkeit und Qualität der 14-G-Biopsie wurden durch die koaxiale Technik nicht beeinträchtigt. Bei der Durchführung einer 16-G-Biopsie waren 5 Zylinder erforderlich, um eine additive diagnostische Genauigkeit von > 99 % zu erreichen. Ohne koaxiale Führung benötigte die CNB mit 16-G mindestens 3 Proben, während 5 Nadelpassagen mit koaxialer 16-G-Biopsie erforderlich waren.

Schlussfolgerung Die diagnostische Treffsicherheit und Qualität der ultraschallgeführten Stanzbiopsie waren unabhängig vom Einsatz einer koaxialen Technik mit der 16-G-Nadel geringer als mit der 14-G-Nadel.

Key words

biopsy - ultrasound - breast - needle - gauge


Publication History

Received: 13 May 2019

Accepted: 03 September 2019

Article published online:
02 December 2019

© 2020. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Fuhrman GM, Cederbom GJ, Bolton JS. et al. Image-guided core-needle breast biopsy is an accurate technique to evaluate patients with nonpalpable imaging abnormalities. Ann Surg 1998; 227: 932-939
    CrossrefPubMedGoogle Scholar
  • 2 King TA, Fuhrman GM. Image-guided breast biopsy. Semin Surg Oncol 2001; 20: 197
    CrossrefPubMedGoogle Scholar
  • 3 Interdisciplinary S3-Guidelines for the Diagnosis, Treatment and Follow-up Care of Breast Cancer, version 4.0, 2017. www.senologie.org
    PubMedGoogle Scholar
  • 4 Buchberger W, Niehoff A, Obrist P. et al. Sonographically guided core needle biopsy of the breast: technique, accuracy and indications. Radiologe 2002; 42: 25-32
    CrossrefPubMedGoogle Scholar
  • 5 Liberman L, Feng TL, Dershaw DD. et al. US-guided core breast biopsy: use and cost-effectiveness. Radiology 1998; 208: 717-723
    CrossrefPubMedGoogle Scholar
  • 6 King TA, Cederbom GJ, Champaign JL. et al. A core breast biopsy diagnosis of invasive carcinoma allows for definitive surgical treatment planning. Am J Surg 1998; 176: 497-501
    CrossrefPubMedGoogle Scholar
  • 7 Parker SH, Jobe WE, Dennis MA. et al. US-guided automated large-core breast biopsy. Radiology 1993; 187: 507-511
    CrossrefPubMedGoogle Scholar
  • 8 de Paredes ES, Langer TG, Cousins J. Interventional breast procedures. Curr Probl Diagn Radiol 1998; 27: 133-184
    CrossrefPubMedGoogle Scholar
  • 9 Liberman L. Clinical management issues in percutaneous core breast biopsy. Radiol Clin Noth Am 2000; 38: 791-807
    CrossrefPubMedGoogle Scholar
  • 10 Fishman JE, Milikowski C, Ramsinghani R. et al. US-guided core needle biopsy of the breast: how many specimens are necessary?. Radiology 2003; 226: 779-782
    CrossrefPubMedGoogle Scholar
  • 11 Schulz-Wendtland R, Aichinger U, Krämer S. et al. Sonographical Breast Biopsy: How Many Core Biopsy Specimen Are Needed?. Fortschr Röngtenstr 2003; 175: 94
    PubMedGoogle Scholar
  • 12 Parker SH, Burbank F, Jackman RJ. et al. Percutaneous large-core breast biopsy: a multi-institutional study. Radiology 1994; 193: 359-364
    CrossrefPubMedGoogle Scholar
  • 13 Schoonjans JM, Brem RF. Fourteen-gauge ultrasonographically guided large-core needle biopsy of breast masses. J Ultrasound Med 2001; 20: 967-972
    CrossrefPubMedGoogle Scholar
  • 14 Schueller G, Jaromi S, Ponhold L. et al. US-guided 14-gauge core-needle breast biopsy: results of a validation study in 1352 cases. Radiology 2008; 248: 406-413
    CrossrefPubMedGoogle Scholar
  • 15 Youk JH, Kim EK, Kim MJ. et al. Sonographicallyguided 14-gauge core needle biopsy of breast masses: a review of 2420 cases with long-term follow-up. Am J Roentgenol 2008; 190: 202-207
    CrossrefPubMedGoogle Scholar
  • 16 Kirshenbaum K, Keppke A, Hou K. et al. Reassessing specimen number and diagnostic yield of ultrasound guided breast core biopsy. Breast J 2012; 18: 464-469
    CrossrefPubMedGoogle Scholar
  • 17 Bolívar AV, Alonso-Bartolomé P, García EO. et al. Ultrasound-guided core needle biopsy of non-palpable breast lesions: a prospective analysis in 204 cases. Acta Radiolog 2005; 45: 690
    CrossrefPubMedGoogle Scholar
  • 18 Crystal P, Koretz M, Shcharynsky S. et al. Accuracy of sonographically guided 14-gauge core needle biopsy: results of 715 consecutive breast biopsies with at least two-year follow-up of benign lesions. J Clin Ultrasound 2005; 33: 47-52
    CrossrefPubMedGoogle Scholar
  • 19 Madjar H, Ohlinger R, Mundinger A. et al. BI-RADS-analogue DEGUM criteria for findings in breast ultrasound--consensus of the DEGUM Committee on Breast Ultrasound. Ultraschall in Med 2006; 27: 374-379
    Article in Thieme ConnectPubMedGoogle Scholar
  • 20 Uematsu T. How to choose needles and probes for ultrasonographically guided percutaneous breast biopsy: a systematic approach. Breast Cancer 2012; 19: 238-241
    CrossrefPubMedGoogle Scholar
  • 21 Biganzoli L, Marotti L, Hart CD. et al. Quality indicators in breast cancer care: An update from the EUSOMA working group. Eur J Cancer 2017; 86: 59-81
    CrossrefPubMedGoogle Scholar
  • 22 Mohan S, Mehra M, Petrizzo M. et al. A Toolkit for the Management of Protocol Deviations. Ther Innov Regul Sci 2016; 50: 791-800
    CrossrefPubMedGoogle Scholar
  • 23 Piaggio G, Elbourne DR, Evans SJ. et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006; 295: 1152-1160
    CrossrefPubMedGoogle Scholar
  • 24 Piaggio G, Elbourne DR, Pocock SJ. et al. Reporting of noninferiority and equivalence randomized trials: extensionof the CONSORT 2010 statement. JAMA 2012; 308: 2594-2604
    CrossrefPubMedGoogle Scholar
  • 25 Ahn S, Park SH, Lee KH. How to demonstrate similarity by using noninferiority and equivalence statistical testing in radiology research. Radiology 2013; 267: 328-338
    CrossrefPubMedGoogle Scholar
  • 26 Guideline on multiplicity issues in clinical trials: European Medicines Agency – Science Medicines Health. 2017
    PubMedGoogle Scholar
  • 27 Mehra M, Kurpanek K, Petrizzo M. et al. The Life Cycle and Management of Protocol Deviations. Ther Innov Regul Sci 2014; 48: 762-777
    CrossrefPubMedGoogle Scholar
  • 28 Meyer JE, Smith DN, Lester SC. et al. Large-core needle biopsy of nonpalpable breast lesions. JAMA 1999; 281: 1638-1641
    CrossrefPubMedGoogle Scholar
  • 29 Parker SH, Lovin JD, Jobe WE. et al. Stereotactic breast biopsy with a biopsy gun. Radiology 1990; 176: 741-747
    CrossrefPubMedGoogle Scholar
  • 30 Helbich TH, Rudas M, Haitel A. et al. Evaluation of needle size for breast biopsy: comparison of 14-, 16-, and 18-gauge biopsy needles. Am J Roentgenol 1998; 171: 59-63
    CrossrefPubMedGoogle Scholar
  • 31 Nath ME, Robinson TM, Tobon H. et al. Automated large-core needle biopsy of surgically removed breast lesions: comparison of samples obtained with 14-, 16-, and 18-gauge needles. Radiology 1995; 197: 739-742
    CrossrefPubMedGoogle Scholar
  • 32 Lai HW, Wu HK, Kuo SJ. et al. Differences in accuracy and underestimation rates for 14- versus 16-gauge core needle biopsies in ultrasound-detectable breast lesions. Asian J Surg 2013; 36: 83-88
    CrossrefPubMedGoogle Scholar
  • 33 Zhou JY, Tang J, Wang ZL. et al. Accuracy of 16/18G core needle biopsy for ultrasound-visible breast lesions. World J Surg Oncol 2014; 12: 7
    CrossrefPubMedGoogle Scholar
  • 34 Giuliani M, Rinaldi P, Rella R. et al. Effect of Needle Size in Ultrasound-guided Core Needle Breast Biopsy: Comparison of 14-, 16-, and 18-Gauge Needles. Clin Breast Cancer 2017; 17: 536-543
    CrossrefPubMedGoogle Scholar
  • 35 Huang ML, Hess K, Candelaria RP. et al. Comparison of the accuracy of US-guided biopsy of breast masses performed with 14-gauge, 16-gauge and 18-gauge automated cutting needle biopsy devices, and review of the literature. Eur Radiol 2017; 27: 2928-2933
    CrossrefPubMedGoogle Scholar
  • 36 Hahn M, Krainick-Strobel U, Toellner T. et al. Interdisciplinary consensus recommendations for the use of vacuum-assisted breast biopsy under sonographic guidance: first update 2012. Ultraschall in Med 2012; 33: 366-371
    Article in Thieme ConnectPubMedGoogle Scholar
  • 37 Hahn M, Okamgba S, Scheler P. et al. Vacuum-assisted breast biopsy: A comparison of 11-gauge and 8-gauge needles in benign breast disease. World Journal of Surgical Oncology 2008; 6: 1-5
    CrossrefPubMedGoogle Scholar