Presentation
Prospective randomized study comparing cryo-assisted and needle-wire localization of ultrasound-visible breast tumors

Presented at the 7th Annual Meeting of the American Society of Breast Surgeons, Baltimore, Maryland, April 5–9, 2006
https://doi.org/10.1016/j.amjsurg.2006.06.012Get rights and content

Abstract

Background

This study compared the surgical results of 2 localization methods—cryo-assisted localization (CAL) and needle-wire localization (NWL)—in patients undergoing breast lumpectomy for breast cancer.

Methods

A total of 310 patients were treated in an institutional review board–approved study with 18 surgeons at 17 sites. Patients were randomized 2:1 to undergo either intraoperative CAL or NWL. A cryoprobe was inserted under ultrasound guidance in the operating room and an ice ball created an 8- to 10-mm margin around the lesion. The palpable ice ball then was dissected. NWL was placed according to institutional practice and resection was performed in a standard fashion. Surgical margins, complications, re-excisions, tissue volume, procedure times, ease of localization, specimen quality, and patient satisfaction were evaluated. Positive margins were defined as any type of disease present 1 mm or less from any specimen edge.

Results

Positive margin status did not differ between the 2 groups (28% vs. 31%). The volume of tissue removed was significantly less in the CAL group (49 vs. 66 mL, P = .002). Re-excisions were similar in both groups. CAL was superior in ease of lumpectomy, quality of specimen, acute surgical cosmesis, short-term cosmesis, patient satisfaction, and overall procedure time for the patient. CAL had a lower invasive positive margin rate (11% vs. 20%, P = .039) but a higher observed ductal carcinoma in situ–positive margin rate (30% vs. 18%, approaching statistical significance, P = .052).

Conclusions

CAL is a preferred alternative to standard wire localization because it provides a palpable template, removes less tissue and improves cosmesis, decreases overall procedure time, and is more convenient for the patient and surgeon.

Section snippets

Study design and patient selection

Institutional review boards at each site approved the prospective, 2:1 randomized study comparing CAL with NWL. A maximum of 330 patients in both arms were to be treated in this study, with the intention to evaluate at least 300. The primary safety end point was designed to show that the combination of complications and re-excisions in the CAL arm would be lower than that in the NWL arm. The primary efficacy end point was designed to show that the CAL arm would show lower positive margin rates

Results

A total of 319 patients were treated in the study and 310 were evaluated. Patient and lesion characteristics are listed in Table 1 and none of the screening items showed differences between the 2 groups. All 310 evaluated patients (206 with CAL, 104 with NWL) had an ultrasound-visible lesion, or had the lesion/area of calcifications marked with an ultrasound-visible clip for later localization. Patients were required to have a mammogram or MRI to rule out bilateral disease, multicentric

Comments

This study shows that CAL, compared with NWL, can be more precise by removing less breast tissue with a comparable rate of positive margins. It also points out that margin status even in the best of circumstances remains a problem that plagues surgeons and patients. A number of small studies have compared standard needle localization with other forms of localization in an attempt to decrease the intervention for the patient and improve the margin status (Table 5). For example, although a few

Acknowledgments

The authors would like to acknowledge additional subinvestigators: Julie Mack, M.D. (Lancaster General Hospital, Lancaster, PA); James Koness, M.D., and Arnold Hermann, M.D. (Women and Infants Hospital, Providence, RI); and Zandra Cheng (Anne Arundel Medical Center, Annapolis, MD). In addition, significant contributions to the study were made by Beth Boyd, R.N. (Advanced Breast Care, Marietta, GA); Karl Hibler, M.S. (statistician, Plymouth, MN); and all of the study coordinators.

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