Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma. A multicentre observational study.
- Conditions
- vulvacarcinomaVulvar cancer100385881004778910029903
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 243
In order to be eligible for the study (non SLN cohort and SLN cohort, group
A-C): - Possible to understand and read Dutch. - Possible to understand the
study and give informed consent. - No age limit specified. - Patients should
mentally, physically and geographically be able to undergo follow-up. In order
to be eligible to undergo the SLN procedure, a subject must meet all of the
following criteria: - First local recurrent SCC of the vulva. - Previous
treatment with wide local excision or (partial) vulvectomy tumours < 4 cm., not
encroaching in urethra, vagina or anus with clinically negative inguinofemoral
lymph nodes. - Localisation and size of the tumour are such that perilesional
injection of the tracers at three or four sites is possible. - Preoperative
imaging does not show enlarged (> 10 mm sort axis) or suspicious nodes. - Fit
for surgery
Potential subject who meets any of the following criteria should not undergo
the SLN procedure in the study arm (A-B), the patient can be asked for the non
SLN cohort. - Inoperable tumours and tumours with diameter > 4 cm. - Patients
with inguinofemoral lymph nodes at palpation clinically suspect for metastases,
at radiology enlarged (> 10 mm short axis) / suspicious groin nodes and with
cytological proven inguinofemoral lymph node metastases. - A history of
bilateral IFL and radiotherapy to the groins. - A lateral tumour and history of
ipsilateral IFL and ipsilateral radiotherapy. - Tumour encroaching urethra,
vagina, or anus. - Previous surgery of the vulva was not radical (margin < 1
mm) and additional treatment (2nd surgery or radiotherapy) was not performed. -
Multifocal recurrent disease of the vulva. - Synchronous, non- curable 2nd
malignancy.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary end point is the number of groin recurrences after SLN procedure.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Success rate of the SLN procedure, surgical drawbacks, wound healing problems,<br /><br>long term sequela, and quality of life in women treated for a 1st recurrent<br /><br>vulvar cancer.</p><br>