Breast Neoplasms Clinical Trial
— AMBULANTOfficial 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.
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | August 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Netherlands | Medical Center Alkmaar | Alkmaar | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Medical Center Alkmaar |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain during SNP under local anaesthesia | Pain during SNP under local anaesthesia is measured with a Numeric Pain Rating Scale | 6 months | No |
Other | Duration of SNP under local anaesthesia | 6 months | No | |
Other | Duration of SNP under general anaesthesia | 6 months | No | |
Other | Number of lymph nodes excised by SNP under local anaesthesia | 6 months | No | |
Other | Number of lymph nodes excised by SNP under general anaesthesia | 6 months | No | |
Primary | Number of operations under general anaesthesia | 6 months | No | |
Primary | Number of operations under local anaesthesia | 6 months | No | |
Primary | The number of patients in whom breast surgery is performed =21 days. | 6 months | No | |
Secondary | Quality of Life | Quality of Life is measured with the WHOQOL-bref questionnaire | 6 months | No |
Secondary | Depressive symptoms | Depressive symptoms are measured with the Centre for Epidemiological Studies-Depression scale (CES-D) | 6 months | No |
Secondary | Anxiety | Anxiety is measured with the State-and-Trait-Anxiety-Inventory (STAI) | 6 months | No |
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