Trial Information

A Prospective, Controlled Study To Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade Compared to Traditional Electrosurgery

Breast conservation therapy (BCT) is the standard surgical treatment for breast cancer. The
goal of BCT is total excision of the malignant lesion while simultaneously preserving the
cosmetic appearance and functionality of the breast. Despite advances in technique and
pathologic analysis; however, 20-50% of malignant breast lump excisions have cancer present
to the edge of the excision margin (defined as a "positive" margin). Excisions that are
found to be margin positive require a secondary excision; however, in these cases residual
disease is found to be present in only 40-70% of cases. Some researchers have hypothesized
that re-excision was unnecessary in a certain percentage of cases. Currently there are no
routinely utilized method for intra-operative interpretation of surgical margins. Touch
preps or imprint cytology has been used in the past in some centers but it is not used
routinely because an experienced cytopathologist is needed to correctly interpret the
slides.

The standard of care to evaluate surgical margins is based on permanent section. Margins
are considered negative if there is greater than 1 mm of normal tissue between cancer cells
to the excised surface. Many factors for this discrepancy have been postulated, including
artifact associated with the inking process and with electrosurgery induced damage of the
margin during excision (thermal injury); therefore, creating a "false positive" impression
of tumor cells present at surgical margins. We propose a clinical study to evaluate the
effects of thermal injury in breast cancer excision using traditional electrosurgery (i.e.,
the "Bovie") compared to the pulsed RF technology with the PEAK PlasmaBlade. We hypothesize
that the PlasmaBlade will impart less thermal injury to the incised breast tissue (malignant
and normal) and will increase the specificity of the margin status. The majority of breast
cancers are removed by traditional electrocautery. We are just starting to utilize this new
technology for soft tissue dissection at UCSD.

The PEAK PlasmaBlade is a family of disposable surgical cutting and coagulation devices that
offer the exacting control of a scalpel and the bleeding control of traditional
electrosurgery without extensive collateral damage. The PlasmaBlade is based on proprietary
pulsed plasma technology. This technology represents an evolutionary leap in the advancement
of radiofrequency surgical technologies, which originated with traditional electrosurgery
and progressed to plasma-mediated energy devices. The PlasmaBlade tissue dissection devices
are FDA-cleared and commercially available.