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NCT Number: NCT05592639

VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Penile Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Inguinal Lymphadenopathy Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Penile Diseases Penile Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, NW1 2BU, United Kingdom

About this study

There is increasing interest in using videoendoscopic inguinal lymph node dissection (ILND) as an alternative to open ILND. Videoendoscopic inguinal lymphadenectomy (VEIL) may decrease complications compared to open ILND and provide equivalent short-term oncological outcomes.

As yet, there have been no randomised-controlled trials (RCTs) comparing these procedures.

VELRAD aims to assess the feasibility of performing a RCT comparing VEIL and open ILND. This will be measured by recruitment rate, the acceptability of the trial design and intervention to clinical stage and patients. Investigators will also collect qualitative data on why patients did or did not agree to be randomised

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy

Procedure

Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.

Primary outcomes

  1. Ability to recruit patients

    Time frame: 18 months

    Ability to recruit patients at the selected sites (recruitment rate)

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • St George's University Hospitals NHS Foundation Trust
  • The Christie NHS Foundation Trust

Registry information

Official study title

Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial

Acronym: VELRAD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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