Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma. A multicentre observational study. - Sentinel Node Procedure in Recurrent Vulvar Carcinoma.

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 243 人开始时间: 待定最近更新: 2024年4月15日

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•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.

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