title: MarginProbe®--final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ.
abstract: The goal in breast conserving surgery (BCS) of ductal carcinoma in situ (DCIS) is removal of the tumor with a clear surgical margin. However, re-excision rates are regrettably high. To date, there are no adequate procedures for intraoperative margin assessment of DCIS. A multicenter, single arm study was conducted to evaluate the benefit of a novel device (MarginProbe®) in intraoperative margin assessment during BCS of DCIS, the associated reduction of re-excisions and the cosmetic outcome of the treated patients. We present results of 42 patients enrolled in 3 German institutions. The device was used as an adjunctive tool to standard of care. The device use was associated with a reduction in re-excision rates by 56%, from 39% to 17% (p = 0.018).
authors.affiliation: Department of Gynecology and Obstetrics, Agaplesion Markus Hospital, Germany. Electronic address: marc.thill@fdk.info.
authors.forename: Marc
authors.initials: M
authors.lastname: Thill
authors.affiliation: Breast Cancer Center, Hospital Essen Mitte, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Dittmer
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital of Schleswig-Holstein, Campus Luebeck, Germany.
authors.forename: Kristin
authors.initials: K
authors.lastname: Baumann
authors.affiliation: Mammazentrum Hamburg, Germany.
authors.forename: Kay
authors.initials: K
authors.lastname: Friedrichs
authors.affiliation: Department of Gynecology and Obstetrics, St. Gertrauden Hospital, Berlin, Germany.
authors.forename: Jens-Uwe
authors.initials: JU
authors.lastname: Blohmer
mesh_terms: D001943:Breast Neoplasms / Q000473:pathology / Q000601:surgery*; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000473:pathology / Q000601:surgery*; D015331:Cohort Studies; D005260:Female; D005858:Germany; D006801:Humans; D007430:Intraoperative Care; D015412:Mastectomy, Segmental / Q000295:instrumentation*; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D017060:Patient Satisfaction; D011358:Product Surveillance, Postmarketing; D012086:Reoperation; D013057:Spectrum Analysis / Q000295:instrumentation
keywords: Breast conservation surgery; Ductal carcinoma in situ; Intraoperative margin assessment; Radiofrequency spectroscopy; Surgical margins