title: Prospective randomized study comparing cryo-assisted and needle-wire localization of ultrasound-visible breast tumors.
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.
authors.affiliation: Anne Arundel Medical Center, 2002 Medical Pkwy., Suite 120, Annapolis, MD 21401, USA. ltafra@aahs.org
authors.forename: Lorraine
authors.initials: L
authors.lastname: Tafra
authors.forename: Richard
authors.initials: R
authors.lastname: Fine
authors.forename: Pat
authors.initials: P
authors.lastname: Whitworth
authors.forename: Michael
authors.initials: M
authors.lastname: Berry
authors.forename: James
authors.initials: J
authors.lastname: Woods
authors.forename: Gregory
authors.initials: G
authors.lastname: Ekbom
authors.forename: Jennifer
authors.initials: J
authors.lastname: Gass
authors.forename: Peter
authors.initials: P
authors.lastname: Beitsch
authors.forename: Daleela
authors.initials: D
authors.lastname: Dodge
authors.forename: Linda
authors.initials: L
authors.lastname: Han
authors.forename: Theodore
authors.initials: T
authors.lastname: Potruch
authors.forename: Darius
authors.initials: D
authors.lastname: Francescatti
authors.forename: Lori
authors.initials: L
authors.lastname: Oetting
authors.forename: J Stanley
authors.initials: JS
authors.lastname: Smith
authors.forename: Howard
authors.initials: H
authors.lastname: Snider
authors.forename: Donna
authors.initials: D
authors.lastname: Kleban
authors.forename: Anees
authors.initials: A
authors.lastname: Chagpar
authors.forename: Stephanie
authors.initials: S
authors.lastname: Akbari
mesh_terms: D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery*; D003452:Cryosurgery; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies; D025321:Surgery, Computer-Assisted; D016896:Treatment Outcome; D016217:Ultrasonography, Mammary