Vulvar Cancer Clinical Trial
Official title:
Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma
Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in which the preoperative evaluation is critical to address surgery between sentinel node biopsy or radical groin lymphadenectomy.
In the absence of clearly an specific guidelines on preoperative vulvar cancer assessment,
the investigators decided to better investigate the role of ultrasound in groin nodes
evaluation through the study 10 sonographic features of suspicion for nodal involvement:
- globular shape (loss of the normal elliptical form)
- long/short axis ratio
- cortical/medulla ratio
- cortical focal bulging or thickening
- hilum anomalies
- inhomogeneous echostructure
- intranodal deposits
- extracapsular spread
- grouping
- vascularization
The standard of comparison is histopathology.
The prospectively evaluation of these parameters will be obtained on the enrolled patients.
The investigators also provided the retrospective review - by specialized staff - of
ultrasound images collected in archives associated with information relating to the
cyto/histological procedures (performed in case of suspicious lymph nodes) in patients who
underwent surgical treatment in the last five years at the study center.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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