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DOI: 10.1055/a-2290-1543
Ultrasound-guided breast-conserving surgery compared to conventional breast-conserving surgery
Ultraschallassistierte versus konventionelle Tumorchirurgie bei brusterhaltender Therapie des Mammakarzinoms Gefördert durch: Deutsche Gesellschaft für Ultraschall in der Medizin FoFö 2015-10-14Clinical Trial: Registration number (trial ID): NCT02840864, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: monocentric, prospective, randomized, and non-blinded parallel-group study
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Abstract
Purpose The goal of breast-conserving surgery is to achieve negative tumor margins, since insufficient marginal distance is associated with more local and distant recurrences. This study investigates whether IOUS (intraoperative ultrasound) can reduce the re-resection rate compared to standard breast surgery, regardless of tumor biology and focality.
Materials and Methods The present study is a monocentric, prospective, randomized, and non-blinded parallel group study conducted between 7/2015 and 2/2018. Patients with sonographically visible breast cancer were randomized into two study arms: 1) breast-conserving surgery with IOUS; 2) conventional arm.
Results 364 patients were included in the study and underwent surgery. Tumor biology, size, and focality were equally distributed in both groups (p = 0.497). The study arms did not differ significantly in the proportion of preoperative wire markings (p= 0.084), specimen weight (p = 0.225), surgery duration (p = 0.849), and the proportion of shavings taken intraoperatively (p = 0.903). Positive margins were present in 16.6% of the cases in the IOUS arm and in 20.8% in the conventional arm (p = 0.347). Re-operation was necessary after intraoperative shavings in 14.4% of cases in the US arm and in 21.3% in the conventional arm (p = 0.100).
Conclusion Although the present study showed a clear difference in the rate of positive tumor margins with IOUS compared to conventional breast surgery without IOUS, this was not statistically significant in contrast to the current literature. This could be due to the high expertise of the breast surgeons, the precise wire marking, or the fact that the IOUS technique was not standardized.
Zusammenfassung
Ziel Das Ziel einer brusterhaltenden Operation stellen negative Tumorränder dar. In dieser Studie wird untersucht, ob intraoperativer Ultraschall (IOUS), unabhängig von der Tumorbiologie und -fokalität, die Zweitoperationsrate im Vergleich zur Standardoperation senken kann.
Material und Methoden Die vorliegende monozentrische, prospektive, randomisierte und unverblindete Parallelgruppenstudie wurde zwischen 7/2015 und 2/2018 durchgeführt. Patientinnen mit sonografisch sichtbarem Mammakarzinom wurden in zwei Studienarme randomisiert: 1) brusterhaltende Operation mit IOUS; 2) konventioneller Arm.
Ergebnisse 364 Patientinnen wurden eingeschlossen und brusterhaltend operiert. Tumorbiologie, -größe und Fokalität waren in beiden Gruppen ähnlich (p = 0,497). Es gab keinen signifikanten Unterschied hinsichtlich der präoperativen Drahtmarkierungen (p = 0,084), des Resektatgewichts (p = 0,225), der Operationsdauer (p = 0,849) oder der intraoperativ entnommenen Shavings (p = 0,903). Positive Ränder waren in 16,6% der Fälle im US-Arm und in 20,8% der Fälle im konventionellen Arm vorhanden (p = 0,347). Eine Zweitoperation war nach intraoperativ entnommenen Shavings in 14,4% der Fälle im US-Arm und in 21,3% der Fälle im konventionellen Arm erforderlich (p = 0,100).
Schlussfolgerung Obwohl die vorliegende Studie einen deutlichen Benefit durch Hinzunahme des IOUS im Vergleich zur konventionellen Brustchirurgie zeigte, war dieser im Gegensatz zur aktuellen Literatur statistisch nicht signifikant. Ursächlich könnten die hohe Expertise der Brustchirurgen, die präzise präoperative Drahtmarkierung und die nicht standardisierte IOUS-Technik sein – es wurde nur „freier Rand“ im Ultraschall verwendet.
Publikationsverlauf
Eingereicht: 12. Dezember 2023
Angenommen nach Revision: 15. März 2024
Artikel online veröffentlicht:
20. Juni 2024
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