PresentationProspective randomized study comparing cryo-assisted and needle-wire localization of ultrasound-visible breast tumors
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.
References (27)
- et al.
Wire localized biopsy of breast lesions: a review of 425 cases found in screening or clinical mammography
Clin Radiol
(1993) - et al.
Intraoperative ultrasound-guided breast biopsy
Am J Surg
(2000) - et al.
Lumpectomy margins, re-excision, and local recurrence of breast cancer
Am J Surg
(2000) - et al.
Encircling guidewire facilitates complete excision of image-localized breast lesions
Am J Surg
(2003) - et al.
A prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a new lesion localization device
Am J Surg
(2002) - et al.
The cosmetic outcome in early breast cancer treated with breast conservation
Eur J Surg Oncol
(1999) Traditional and future management of nonpalpable breast cancer
Am Surg
(1997)- et al.
Decreased breast cancer tumor size, stage, and mortality in Rhode Island: an example of a well-screened population
Cancer Control
(2004) - et al.
Bracketing wires for preoperative breast needle localization
AJR Am J Roentgenol
(2001) - et al.
Preoperative stereotactic hookwire localization of nonpalpable breast lesions with and without the use of a further stereotactic check film
Anticancer Res
(2000)
Nonpalpable breast lesion localization using a curved-end retractable wire
Radiology
Needle-localized biopsy of the breast
Surg Gynecol Obstet
A modified needle-hook wire technique to simplify preoperative localization of occult breast lesions
Radiology
Cited by (64)
Optimal localization strategies for non-palpable breast cancers –A network meta-analysis of randomized controlled trials
2022, BreastCitation Excerpt :The remaining 1055 studies were screened for relevance, before 27 full texts were reviewed. In total, 24 RCTs fulfilled our inclusion criteria and were included in this systematic review and NMAs (Fig. 1) [16,27,41–62]. Of the 24 RCTs included in this analysis, almost 40.0% were conducted in European surgical research institutions (37.5%, 9/24).
Comparative effectiveness of different localization techniques for non-palpable breast cancer. A systematic review and network meta-analysis
2022, European Journal of Surgical OncologyRapid Assessment of Resection Margins During Breast Conserving Surgery Using Intraoperative Flow Cytometry
2021, Clinical Breast CancerSurgical management of early breast cancer
2018, The Breast: Comprehensive Management of Benign and Malignant Diseases
Supported by Sanarus Medical (Pleasanton, CA).