Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma.

Erasmus MC0 个研究点目标入组 150 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•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.

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