Clinical trial NCT02187718: Ambulatory SNP Under Local Anaesthesia in a Subgroup of Breast Cancer Patients - Trial
Official title: A Prospective Single-centre Randomised Controlled Clinical Trial Comparing Sentinel Node Procedure Under Local Anaesthesia to Traditional Sentinel Node Procedure Under General Anaesthesia in Patients <60 Years With a Breast Carcinoma >20 mm.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: Sentinel Lymph Node Biopsy
Local Anaesthesia
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Rationale: In breast cancer (BC) patients, lymph node status is a key prognostic indicator. At present, axillary ultrasound (US) with subsequent fine needle aspiration cytology (FNAC) 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 BC 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 BC patients would benefit most from SNP under LA, the investigators recently analysed 1132 BC 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 BC 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.

Objectives: Reduction of the mean number of operations under general anaesthesia per patient. Improvement of QoL. Reduction of depressive symptoms and experienced anxiety.

Study design: Prospective single centre randomised controlled clinical trial. Study population: Women aged 18 to 60 years who are diagnosed with BC AND with a tumour size of \>20 mm ultrasonographically AND with a negative or inconclusive pre-operative US+FNAC.

Intervention: Sentinel Node Procedure under Local Anaesthesia (SNP under LA) Control: Traditional Sentinel Node Procedure under General Anaesthesia (SNP under GA) Main study parameters: Primary outcome parameters are the number of operations under GA per patient and the number of operations under LA per patient. Secondary outcome parameters are QoL, experienced depressive symptoms and anxiety.

Timeline and statistics: The inclusion period will be conducted from the 1st of July 2014 to the 1st of August 2015, and 80 patients will be enrolled in this study (alpha 0.05; power 0.8). Inclusion of 80 patients will be sufficient to reduce the number of two-stage surgical procedures under general anaesthesia with 30%. Data will be analysed using descriptive statistics, Chi-squared test, Fisher's exact test, Mann-Whitney U test, Kruskall-Wallis test, students t-test, ANOVA, paired t-test, Wilcoxon signed-rank test, Friedman test, Pearson's and Spearman's rank correlation coefficients and finally logistic and linear regression analysis.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-60 years
* Diagnosis of invasive BC (established with core needle biopsy of the breast lesion)
* Breast carcinoma measures \> 20 mm ultrasonographically
* Pre-operative US+FNAC is negative or inconclusive
* No evidence of distant metastases
* ASA Classification I-III
* Signed informed consent

Exclusion Criteria:

* History of previous breast surgery in the affected breast
* History of previous axillary surgery in the ipsilateral axilla
* History of radiation therapy (ipsilateral breast or axilla)
* History of neo-adjuvant therapy (for the BC)
* Known allergy to lidocain

Primary outcomes:
measure: Number of operations under general anaesthesia
timeFrame: 6 months
measure: Number of operations under local anaesthesia
timeFrame: 6 months
measure: The number of patients in whom breast surgery is performed ≤21 days.
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
Other outcomes:
measure: Pain during SNP under local anaesthesia
timeFrame: 6 months
measure: Duration of SNP under local anaesthesia
timeFrame: 6 months
measure: Duration of SNP under general anaesthesia
timeFrame: 6 months
measure: Number of lymph nodes excised by SNP under local anaesthesia
timeFrame: 6 months
measure: Number of lymph nodes excised by SNP under general anaesthesia
timeFrame: 6 months
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
state: Noord-Holland
Study officials:
affiliation: Medical Center Alkmaar
name: Hermien Schreurs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: