Study to Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade

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

The purpose of this research study is to find out more about distinguishing between cancerous and non-cancerous breast cancer cells at the edges of tumors. Using an FDA approved device to remove tumors, this device will be tested to see if it causes less tissue damage and therefore makes it easier to examine the tumor and make sure it is all excised. The tumors will be excised by standard surgical technique, and then the effects of the device on the removed tissues will be studied.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Thornton Hospital
    • La Jolla, California, United States, 92093
      • Rebecca and John Moores Cancer Center
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from the Moores UCSD Cancer Center and the UCSD Medical Center

Description

Inclusion Criteria

• Women or men with an established diagnosis of an invasive ductal carcinoma
• Women or men with tumors > 1cm
• Women undergoing Breast Conservation Operations
• Women or men may have had prior chemotherapy as long as their treatment was completed >2 weeks prior to enrollment with recovery from any toxicities

Exclusion Criteria

• No established diagnosis of breast cancer
• Women or men with tumors <1 cm
• Women or men undergoing total mastectomy
• Women or men who have had prior radiation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the thermal injury artifact produced by traditional electrosurgery vs. the PEAK PlasmaBlade by intensive pathologic analysis both by gross inspection, touch imprint, and permanent histologic analysis.	1 year

Collaborators and Investigators

• Sponsor: Sarah Blair, M.D.
• Collaborators: Medtronic Surgical Technologies
• Investigators: Principal Investigator: Sarah L Blair, MD, University of California, San Diego

Publications and helpful links

General Publications

• Ruidiaz ME, Cortes-Mateos MJ, Sandoval S, Martin DT, Wang-Rodriguez J, Hasteh F, Wallace A, Vose JG, Kummel AC, Blair SL. Quantitative comparison of surgical margin histology following excision with traditional electrosurgery and a low-thermal-injury dissection device. J Surg Oncol. 2011 Dec;104(7):746-54. doi: 10.1002/jso.22012. Epub 2011 Jul 8.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: September 3, 2009
• First Submitted That Met QC Criteria: September 3, 2009
• First Posted (Estimate): September 4, 2009

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Breast; PlasmaBlade; Lumpectomies; Breast conservation therapy
• Other Study ID Numbers: 090314