Preoperative and Intraoperative Sonographic Visibility of Collagen-Based Breast Biopsy Marker Clips

Rationale and Objectives

The aim of this study was to determine the sonographic visibility of implanted collagen-based breast biopsy marker clips in the clinic and operating room.

Materials and Methods

Female patients aged ≥18 years who presented for preoperative surgical evaluation within 4 weeks of ultrasound-guided breast biopsy and collagen-based marker clip placement were eligible for this pilot study. The sonographic visibility of the marker clips was rated from 1 (not visible) to 5 (clearly visible) by surgeons at the preoperative appointment, by radiologists at wire localization, and by surgeons in the operating room. Visibility was considered inadequate for values of 1 or 2 and adequate for values of 3, 4, or 5. The data were compared using Wilcoxon’s signed-rank test for paired differences across physician (radiologist vs surgeon), time (preoperative visit vs day of surgery), and target (lesion vs clip).

Results

Twenty-five patients with 26 lesions were enrolled, and 19 patients returned for all imaging procedures. The mean lesion size was 12 mm (range, 5–24 mm). Adequate marker clip visibility assessed by the surgeons decreased from 80% (20 of 25) at the preoperative appointment to 65% (11 of 17) in the operating room, but the difference was not significant ( P = .27). Visibilities of the lesions and clips were similar at the preoperative appointment ( P = .61), but the clips were significantly less visible on the day of operation ( P = .03).

Conclusion

The sonographic visibility of collagen-based marker clips is variable and likely decreases over time but may be adequate to guide intraoperative surgical excision in many cases.

Breast cancer is the most common major cancer among women in the United States. It is estimated that approximately 180,000 women will be diagnosed with breast cancer, and 40,000 die from the disease annually. On the basis of rates from 2003 to 2005, 12.0% of women alive today will be diagnosed with cancer of the breast at some time during their lifetimes . Whether initially presenting in asymptomatic patients in screening mammography programs or in symptomatic patients who undergo diagnostic imaging evaluation, breast cancers are typically confirmed with image-guided tissue sampling prior to surgical excision.

It is common clinical practice for radiologists to place metallic clips in suspicious lesions at the time of a biopsy to permit localization under mammographic guidance if surgical resection is later indicated . Such image-guided wire localization is performed for nonpalpable lesions to facilitate surgical excision when breast conservation is desired. Wire localization is an invasive procedure that requires local anesthetic and needle insertion under imaging guidance before the patient is taken to the operating room. This intervention, although vital to the success of the surgical procedure, can be challenging to patients. Potential issues of preoperative localization include patient pain, discomfort, and vasovagal episodes as well as potential operating room delays.

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Materials and methods

Case Selection

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Study Procedures

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Statistical Analysis

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Results

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Table 1

Comparison of Visibility Rankings of the Clips and Lesions Using Wilcoxon’s Signed-Rank Test

Visibility Comparison Number of Paired Values Median Difference (Range) Wilcoxon’s Signed-Rank Test P Value Surgeons: preoperative appointment vs operating room Marker clip 17 0 (−4 to 4) .27 Lesion 11 0 (−1 to 4) .43 Day of surgery: radiologists vs surgeons Marker clip 16 1 (−4 to 4) .22 Lesion 13 0 (−3 to 1) .28 Surgeons: marker clip vs lesion Preoperative appointment 14 0 (−3 to 1) .61 Operating room 16 1 (−3 to 4) .03 ∗

A two-sided P value of .05 was considered significant. Complete data were not acquired in some cases.

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Table 2

Summary of Prior Studies of Intraoperative Ultrasound Localization of Masses

Study Number of Patients Number of Lesions Number of Cancers Ultrasound Localization Sensitivity Rifkin et al (1988) ‡ 45 52 3 52/52 (100%) Schwartz et al (1988) ‡ 95 105 9 92/105 (88%) Fornage et al (1994) ∗ 26 26 10 24/26 (92%) Harlow et al (1999) ∗ 62 65 65 65/65 (100%) Paramo et al (1999) ∗ 15 15 3 15/15 (100%) Rahusen et al (1999) ∗ 19 20 19 19/20 (95%) Snider and Morrison (1999) † 29 29 22 29/29 (100%) Smith et al (2000) ‡ 77 81 25 81/81 (100%) Moore et al (2001) § 27 27 27 27/27 (100%) Rahusen et al (2002) † 27 27 27 27/27 (100%) Kaufman et al (2003) || 100 101 101 101/101 (100%) Bennett et al (2005) ∗ 103 115 48 115/115 (100%) Ngo et al (2007) ∗ 70 70 70 67/70 (96%)

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Discussion

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Conclusions

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Acknowledgments

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References

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Preoperative and Intraoperative Sonographic Visibility of Collagen-Based Breast Biopsy Marker Clips

Rationale and Objectives

Materials and Methods

Results

Conclusion

Materials and methods

Case Selection

Study Procedures

Statistical Analysis

Results

Discussion

Conclusions

Acknowledgments

References

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