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

Clin Radiol. 2016 Jun;71(6):551-7. doi: 10.1016/j.crad.2016.02.024. Epub 2016 Mar 31.

Abstract

Aim: 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.

Materials and 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%.

Conclusion: 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Axilla
  • Biopsy, Large-Core Needle / adverse effects
  • Biopsy, Large-Core Needle / methods*
  • Breast Neoplasms / pathology*
  • Endoscopic Ultrasound-Guided Fine Needle Aspiration / adverse effects
  • Endoscopic Ultrasound-Guided Fine Needle Aspiration / methods*
  • Feasibility Studies
  • Female
  • Humans
  • Lymphatic Metastasis
  • Middle Aged
  • Needles / classification*
  • Pilot Projects
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Sentinel Lymph Node / pathology*
  • Sentinel Lymph Node Biopsy / instrumentation*
  • Sentinel Lymph Node Biopsy / methods
  • Vacuum