Ultraschallassistierte Tumorresektion beim Mammakarzinom – eine prospektive, randomisierte, monozentrische Studie (MAC 001)

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 Drahts markiert. Mittels der ultraschallassistierten Tumorchirurgie kann die Rate an R1-Resektionen reduziert werden. Die MAC-001-Studie verglich die ultraschallassistierte Tumorresektion mit der konventionellen drahtmarkierten Operation und untersuchte dabei die R0-Resektionsrate, die Operationszeit und das Resektionsvolumen.

Material und Methode Patientinnen mit einem invasiven duktalen Mammakarzinom wurden in die prospektive, randomisierte, unizentrische Studie eingeschlossen und entweder in den ultraschallassistierten oder drahtmarkierten Arm randomisiert und ausgewertet. Die Studie war unter ClinicalTrial.gov NCT02 222 675 registriert worden.

Ergebnisse 56 Patientinnen erfüllten die Einschlusskriterien, von denen 47 ausgewertet werden konnten. 93 % (25/27) der Patientinnen im ultraschallassistierten Arm hatten im Vergleich zu 65 % (13/20) im drahtmarkierten 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 ultraschallassistierte Tumorresektion kann im Vergleich zur konventionellen drahtmarkierten Operation die R0-Rate bei brusterhaltender Operation signifikant erhöhen. Aus unserer Sicht sollten Brustchirurgen im Ultraschall ausgebildet sein. Ein Ultraschallgerät sollte Bestandteil jedes Brustoperationssaals sein.

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 NCT02 222 675.

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.

Schlüsselwörter

Mammakarzinom - ultraschallassistierte Chirurgie - brusterhaltende Operation

^* Beide Autoren trugen gleichberechtigt als erste Autoren bei.

^** Beide Autoren trugen gleichberechtigt als letzte Autoren bei.

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