VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer (VELRAD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma; Penile Cancer; Inguinal Lymphadenopathy
• Intervention / Treatment: Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. People requiring inguinal lymphadenectomy i.e.

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Videoendoscopic Inguinal Lymphadenectomy; Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy	Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy; Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.
Other: Open Inguinal Lymphadenectomy; Removal of inguinal nodes using Open radical inguinal lymphadenectomy	Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy; Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a surgical technique utilised in removing inguinal lymph nodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to recruit patients	Ability to recruit patients at the selected sites (recruitment rate)	18 months

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust; The Christie NHS Foundation Trust; St George's University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Asif Muneer, MD, University College, London

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Lymphatic Diseases; Penile Diseases; Lymphadenopathy; Penile Neoplasms
• Other Study ID Numbers: 130062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No