title: A randomised pilot study comparing 13 G vacuum-assisted biopsy and conventional 14 G core needle biopsy of axillary lymph nodes in women with breast cancer.
abstract: OBJECTIVE
  To compare the acceptability, safety, and feasibility of vacuum-assisted biopsy (VAB) and core needle biopsy (CNB) of axillary lymph nodes in women with breast cancer.
  
  
  METHODS
  This parallel, non-blinded, randomised study was approved by the National Research Ethics Service. Following written informed consent, women with abnormal appearing axillary lymph nodes and radiologically malignant breast masses were randomised 1:1 to lymph node sampling under local anaesthetic with either 14 G CNB or 13 G VAB in a single UK centre. Primary outcomes were study uptake rate and patient willingness to undergo a repeat procedure if necessary. Procedure duration, immediate and post-procedure pain scores, diagnostic yield, complications, and surgical histopathology were recorded.
  
  
  RESULTS
  Ninety-five women were approached; 81 (85.3%) consented and were randomised. Forty underwent CNB; 40 underwent VAB; one was excluded. Median age was 57 years. The median procedure time was 2 minutes for both techniques. The median number of samples obtained was three for CNB and four for VAB. Median pain scores for the procedure and first 3 days were 1/10 and 1/10 for CNB and 1/10 and 2/10 for VAB (p=0.11 and 0.04). More women were prepared to undergo repeat CNB compared to VAB, but the difference was not significant (38/39 versus 33/39; p=0.11). Two patients developed a haematoma after VAB. One CNB and six VABs failed to yield adequate tissue (p=0.11), but the sensitivity was similar at 79% and 78%.
  
  
  CONCLUSIONS
  Study uptake was high. Acceptability of the two procedures was similar, but VAB was associated with more post-procedure pain. The sensitivity appears to be similar.
authors.affiliation: Nightingale Centre and Genesis Prevention Centre, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, UK; Centre for Imaging Sciences, Institute of Population Health, University of Manchester, Oxford Road, Manchester M13 9PT, UK. Electronic address: anthony.maxwell@manchester.ac.uk.
authors.forename: A J
authors.initials: AJ
authors.lastname: Maxwell
authors.affiliation: Nightingale Centre and Genesis Prevention Centre, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, UK; Institute of Cancer Sciences, University of Manchester, Manchester Cancer Research Centre, Wilmslow Road, Manchester M20 4QL, UK.
authors.forename: N J
authors.initials: NJ
authors.lastname: Bundred
authors.affiliation: Nightingale Centre and Genesis Prevention Centre, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, UK.
authors.forename: J
authors.initials: J
authors.lastname: Harvey
authors.affiliation: Department of Histopathology, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, UK.
authors.forename: R
authors.initials: R
authors.lastname: Hunt
authors.affiliation: Medical Statistics Department, Education and Research Centre, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, UK; Centre for Biostatistics, Institute of Population Health, University of Manchester, Oxford Road, Manchester M13 9PL, UK.
authors.forename: J
authors.initials: J
authors.lastname: Morris
authors.affiliation: Nightingale Centre and Genesis Prevention Centre, University Hospital of South Manchester, Southmoor Road, Manchester M23 9LT, UK; Centre for Imaging Sciences, Institute of Population Health, University of Manchester, Oxford Road, Manchester M13 9PT, UK.
authors.forename: Y Y
authors.initials: YY
authors.lastname: Lim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001365:Axilla; D062005:Biopsy, Large-Core Needle / Q000009:adverse effects / Q000379:methods*; D001943:Breast Neoplasms / Q000473:pathology*; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000009:adverse effects / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009339:Needles / Q000145:classification*; D010865:Pilot Projects; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D000071036:Sentinel Lymph Node / Q000473:pathology*; D021701:Sentinel Lymph Node Biopsy / Q000295:instrumentation* / Q000379:methods; D014618:Vacuum