Active — Not RecruitingNot Applicable

VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

United Kingdom50 participantsStarted 2022-06-23

Plain-language summary

Assess the feasibility of performing a RCT comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with genital cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. People requiring inguinal lymphadenectomy i.e.
✓. Patients with squamous cell carcinoma or mucosal melanoma of the penis \> T1bG2 or patients with male genital cancer requiring inguinal lymphadenectomy
✓. Patients unsuitable for dynamic sentinel node biopsy (DSNB) with impalpable nodes: previous penectomy or non-visualisation at previous DSNB
✓. Previous DSNB with metastatic inguinal nodes on histology or FNA positive nodes on cytology who require a completion radical inguinal lymphadenectomy
✓. Small volume palpable inguinal lymph nodes (\< 2 cm on CT) not fixed to skin
✓. Age \> 18 years

Exclusion criteria

✕. Unfit for surgery
✕. People unlikely to benefit from lymphadenectomy because of advanced cancer
✕. Those with palpable inguinal lymph nodes fixed to skin or adjacent structures
✕. Does not want to participate in the trial or unable to provide informed consent

What they're measuring

Ability to recruit patients

Timeframe: 18 months

Trial details

NCT IDNCT05592639

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05

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