Ambulatory SNP under local anaesthesia in a subgroup of breast cancer patients - trial

In breast cancer patients, lymph node status is a key prognostic indicator. At
present, axillary ultrasound with subsequent fine needle aspiration cytology of
suspicious lymph nodes (US+FNAC) is widely used as a pre-operative staging
method. When US+FNAC is negative, a sentinel node procedure (SNP) is performed
during breast surgery. Nowadays, an axillary lymph node dissection (ALND) is
generally performed if one of the abovementioned diagnostic entities reveals
lymph node metastases. However, the extensive role of ALND in breast cancer
patients with lymph node metastases may change or diminish in upcoming years
due to emerging evidence that completion ALND (cALND) does not affect
disease-free survival and overall survival in early BC patients with (sentinel)
node-positive disease. Whether ALND is needed in these patients, should be
based on (axillary) tumour load. Because of the fact that tumour load can only
be reliably evaluated by SNP and not by US+FNAC, the role of SNP might become
even more important in upcoming years. Ideally, the status of this sentinel
lymph node is known prior to breast surgery, so a patient tailored treatment
plan can be made and discussed with the patient before breast surgery. In this
context, it would be very logical to perform a SNP
under local anaesthesia (LA), prior to breast surgery. This might not only lead
to significantly less two-step surgical procedures under general anaesthesia
(GA), but might also lead to a reduction of depressive symptoms and anxiety and
improved quality of life (QoL) of BC patients, because BC patients are in
particular risk for psychological distress in the first three months after
diagnosis of BC. Knowing lymph node status and the complete treatment plan as
soon as possible (by performing a SNP under LA), might reduce this
psychological distress. To investigate which breast cancer patients would
benefit most from SNP under LA, we recently analysed 1132 breast cancer
patients retrospectively. Both prevalence of axillary lymph node metastases and
prevalence of false negative results of US+FNAC were directly associated with
age <60 years and with primary breast tumour size >20 mm. Hence, these breast
cancer patients might benefit most from SNP under LA. In the present study, the
value of SNP under LA in these BC patients (i.e. <60 years with a breast
carcinoma >20 mm) will be analysed.

Reduction of the mean number of operations under general anaesthesia per
patient. Improvement of Quality of Life. Reduction of depressive symptoms and
experienced anxiety.

Prospective single centre randomised controlled clinical trial.

Sentinel Node Procedure under Local Anaesthesia (SNP under LA)

Risks that are associated with participation are minimal. Risks that are
associated with the sentinel node procedure under local anaesthesia are the
following:
- pain during the procedure. If the patient reports pain during the procedure,
more local anaesthetic is injected.
- Lidocain is used as a local anaesthetic during the sentinel node procedure
under local anaesthesia. Lidocain may cause (1-10% of patients) tingling in the
anaesthetized area, dizziness and nausea. More serious side effects, such as
drowsiness and unconsciousness are very rare. Allergic reactions to lidocain
are very rare (0.01-0.1% of patients).