Every year more than 100,000 women in the United States undergo a lumpectomy, a conservative procedure to remove cancerous tumors while preserving the breast. The surgeon's goal is to attain a tumor-free, or negative, surgical margin the first time they operate. Current surgical tools may cause heat damage to the tissue samples needed for examination by a pathologist in order to identify the presence of cancerous cells on the edges of tumors.
Surgeons at Moores UCSD Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center based at UC San Diego, are conducting a clinical trial to evaluate whether a FDA-approved device that uses radiofrequency energy may cause less collateral damage to excised tissue, therefore making it easier to examine the tumor and ensure it is entirely removed. The effects of the device will then be studied.
"The challenge in performing a lumpectomy is to completely remove all tumor so that a repeat surgery is not needed," said Sarah Blair, MD, associate clinical professor of surgery at the UC San Diego School of Medicine. "Tools that utilize electrical energy may distort or damage tissue. Moores UCSD Cancer Center is studying low temperature energy sources which may provide better pathology samples."
Nationally, close to 50 percent of malignant breast lump excisions result in positive margin status, requiring additional procedures. The traditional method of tissue evaluation relies upon microscopic examination; however, electrosurgical techniques may damage tissue samples within 1- 2 mm of the margin. Positive margin rates at Moores UCSD Cancer Center are found in fewer than 20 percent of cases.
Blair and colleagues published survey results in the November 2009 edition of the Journal of the American College of Surgeons highlighting a wide variety of practice patterns in the US for handling surgical margins in breast conservation treatment. The paper called for additional study of treatments to examine the minimal amount of surgical treatment necessary in conjunction with chemotherapy and radiation to better control cancer rates.
According to the Centers for Disease Control and Prevention, breast cancer is the most common form of cancer in women aside from non-melanoma skin malignancies. Breast cancer is the number one cause of cancer death in Hispanic women. It is the second most common cause of cancer death in white, black, Asian/Pacific Islander, and American Indian/Alaska Native women.
This IRB- approved clinical trial to evaluate surgical excision margins in malignant breast lumpectomies is sponsored by PEAK Surgical, Inc.
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