Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma. A multicentre observational study.
- Conditions
- vulva cancer
- Registration Number
- NL-OMON22671
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
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
A 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 To investigate the safety of replacing complete IFL by SLN procedure in women with a first recurrent vulvar SCC in tumours < 4 cm.
- Secondary Outcome Measures
Name Time Method 1)To investigate the feasibility of the SLN procedure in patients with a first recurrence of vulvar SCC. (Success rate of the SLN procedure, surgical drawbacks)<br>2)To evaluate the short and long-term morbidity associated with the sentinel lymph node procedure in patients with a first recurrence of vulvar SCC.(complications, wound healing problems, long term sequela, quality of life)<br>3)To evaluate the short and long-term morbidity associated with treatment of a first recurrence of vulvar SCC.(complications, wound healing problems, long term sequela, quality of life)<br><br>