Sentinel Lymph Node, Breast Cancer
Conditions
Keywords
breast cancer, isosulfan blue, massage, sentinel lymph node, sentinel lymph node biopsy
Brief summary
Sentinel lymph node biopsy is important for staging in patients with breast cancer and changes the way of surgery. One of the most commonly used methods to find the sentinel lymph node during surgery is to apply blue dye around the areola and then search for the sentinel lymph node. Breast massage is recommended following administration of the blue dye. However, the necessity of this massage is controversial. In this study, investigators will try to find out whether massage of the breast after blue dye injection has any positive effect on finding the sentinel lymph node.
Detailed description
This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI\>30 and age\>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.
Interventions
PROCEDURESentinel lymph node biopsy
Sentinel lymph node biopsy will be performed.
PROCEDUREBreast massage
Breast massage will be performed for a duration of 5 minutes.
PROCEDUREBlue dye injection
Isosulfan blue dye will be injected in the subareolar region of the breast
Sponsors
Celal Bayar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
not necessary
Intervention model description
This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI\>30 and age\>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* the diagnosis of breast cancer by biopsy * participants voluntarily participated in the clinical trial and signed informed consent
Exclusion criteria
* had previous sentinel lymph node biopsy or axillary surgery * had neoadjuvant chemotherapy * had clinical hints of axillary lymph node metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel lymph node detection rate | 2 weeks | Participants will be followed until the pathology report is finalized |
Countries
Turkey (Türkiye)
Outcome results
None listed