Ultrasound-Assisted Tumor Surgery in Breast Cancer – A Prospective, Randomized, Single-Center Study (MAC 001)

Abstract

Purpose Breast-conserving therapy is associated with a risk of tumor-involved margins. For intraoperative orientation, non- palpable or indistinctly palpable lesions are wire-marked prior to surgery. Ultrasound-guided surgery has the potential to reduce the number of tumor-involved margins. In the MAC 001 trial we evaluated ultrasound-guided breast-conserving surgery compared to wire-guided surgery with regard to free tumor margins, duration of surgery and resection volume.

Materials and Methods In this randomized, prospective, single-center controlled trial, patients with ductal invasive breast cancer were recruited for either ultrasound-guided or wire localization surgery. Primary outcomes were tumor-free resection margins, the reoperation rate and the resection volume in each group. The results were analyzed by intention to treat. The trial was registered under ClinicalTrials.gov NCT02222675.

Results 56 patients were assessed, and 47 patients were evaluated in the trial. 93 % (25/27) of the patients in the ultrasound arm had an R0 reoperation compared to 65 % (13/20) in the wire localization control arm. This result was statistically significant (p = 0.026). No statistical difference was found for the resection volume or the duration of surgery between the two arms. No major complication was seen in either arm.

Conclusion Ultrasound-assisted breast surgery significantly increases the possibility of tumor-free margins and therefore reduces the risk of reoperations. Breast surgeons should be trained in ultrasound and ultrasound should be available in every breast surgery operating room.

Zusammenfassung

Ziel Die brusterhaltende Therapie des Mammakarzinoms unterliegt dem Risiko der R1-Resektion. Zur intraoperativen Orientierung werden nicht oder unsicher palpable Tumoren vor der Operation mittels Draht markiert. Mittels der ultraschall-assistierten Tumorchirurgie kann die Rate an R1 Resektionen reduziert werden. Die MAC 001 Studie verglich die ultraschall-assistierte Tumorchirurgie mit der konventionellen drahtmarkierten Chirurgie und untersuchte dabei die R0-Resektionsrate, Operationszeit und das Resektionsvolumen.

Material und Methode Patientinnen mit einem invasiv duktalen Mammakarzinom wurden in die prospektiv, randomisierte, unizentrische Studie eingeschlossen und entweder in den ultraschall-assistierten oder Draht markierten Arm randomisiert und ausgewertet. Die Studie war unter ClinicalTrial.gov NCT02222675 registriert worden.

Ergebnisse 56 Patientinnen erfüllten die Einschlusskriterien von dehnen 47 ausgewertet werden konnten. 93 % (25/27) der Patientinnen im ultraschall-assistierten Arm hatten im Vergleich zu 65 % (13/20) im Draht markierten Kontrollarm eine R0 Resektion. Das Ergebnis war statistisch signifikant (p = 0.026). In Bezug auf das entnommene Resektionsvolumen und die Operationsdauer wurde kein signifikanter Unterschied beobachtet. Revisionspflichtige Komplikationen traten nicht auf.

Schlussfolgerung Die ultraschall-assistierte Tumorchirurgie kann im Vergleich zur konventionellen Draht markierten Tumorchirurgie die R0-Rate bei brusterhaltender Operation signifikant erhöhen. Aus unserer Sicht sollten Brustchirurgen im Ultraschall ausgebildet sein. Ein Ultraschallgerät sollte Bestandteil jedes Brustoperationssaales sein.

Key words

breast cancer - ultrasound-guided surgery - breast-conserving surgery

^* both authors contributed equally first

^** both authors contributed equally last

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