Vacuum-assisted and conventional core biopsy of axillary lymph nodes
Research type
Research Study
Full title
A feasibility study comparing the safety and acceptability of vacuum-assisted biopsy and conventional 14-gauge core biopsy in the diagnosis of ultrasonically indeterminate and abnormal axillary lymph nodes
IRAS ID
129014
Contact name
Anthony Maxwell
Contact email
Sponsor organisation
University Hospital of South Manchester NHS Foundation Trust
Research summary
Women with invasive breast cancer undergo ultrasound of the axilla (armpit) before surgery to detect spread of disease (metastases) to the lymph nodes. If this is normal the woman undergoes operative sentinel lymph node biopsy (SLNB), usually at the same time as surgery to the breast. If the SLNB is positive the woman undergoes axillary node clearance at a subsequent operation.
Abnormal axillary lymph nodes on ultrasound undergo needle sampling. If metastases are confirmed the woman undergoes node clearance at the same operation as surgery to the breast. The number of women who need to undergo more than one operation can be minimised by maximising the number of women with axillary metastatic disease who are diagnosed before surgery.
Ultrasound has a sensitivity of ~60% for the detection of metastatic lymph nodes. Ultrasound-guided biopsy of nodes that contain metastases has a sensitivity of ~80%. This is less than 100% because the needle may miss the part of the lymph node containing the tumour deposit. Increasing the volume of tissue removed may increase accuracy.
Vacuum-assisted biopsy (VAB) is a needle technique performed under local anaesthetic which allows more tissue to be removed than with a standard needle. Repeated samples can be taken with a single needle insertion, allowing large numbers of samples to be quickly taken. VAB of breast abnormalities is well tolerated by patients.
This study will determine whether the use of VAB in the axilla is safe and acceptable to patients and whether a larger randomised study comparing the two techniques is feasible. The results will inform the design of a larger study which will determine whether VAB significantly increases the preoperative diagnosis rate of axillary metastatic disease. If it does, its use will result in a reduction in the number of second operations in women with breast cancer.
REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0326
Date of REC Opinion
29 May 2013
REC opinion
Further Information Favourable Opinion