Perkutane ultraschallgestützte Stanzbiopsie: Vergleich von 16- und 14-Gauge-Nadel und Einfluss der koaxialen Führung bei 1065 Brustbiopsien – Eine prospektive, randomisierte klinische Nichtunterlegenheitsstudie

Zusammenfassung

Ziel Die ultraschallgestützte Stanzbiopsie (CNB) gilt als Standardbewertung für die Diagnose sonografisch nachweisbarer verdächtiger Brustläsionen. Basierend auf nicht randomisierten Studien, empfehlen die aktuellen deutschen Leitlinien die Biopsie von mindestens 3 Zylindern mit ≤ 14-Gauge(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 Genauigkeit (Treffsicherheit) und Qualität verbessert. Daher wurde in einer prospektiven, monozentrischen, nicht verblindeten, randomisierten, kontrollierten klinischen Nichtunterlegenheitsstudie die diagnostische Genauigkeit der Stanzbiopsie mit 16-G- versus 14-G-Nadel mit und ohne Koaxialführung bewertet.

Material und Methoden 1065 Brustbiopsien wurden aufgenommen, um die Zahl 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 die 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 Genauigkeit und die Qualität der ultraschallgeführten Stanzbiopsie waren unabhängig vom Einsatz einer koaxialen Technik mit der 16-G-Nadel geringer als mit der 14-G-Nadel.

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.

Schlüsselwörter

Biopsie - Ultraschall - Brust - Nadel - Gauge

Key words

biopsy - ultrasound - breast - needle - gauge

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