VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

Not Applicable

Active, not recruiting

• Conditions: Melanoma; Inguinal Lymphadenopathy; Penile Cancer
• Interventions: Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy

• Registration Number: NCT05592639
• Lead Sponsor: University College, London

Brief 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.

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 Timeline

• Study Start: 2022-06-23
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-25
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Videoendoscopic Inguinal Lymphadenectomy	Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy	Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy
Open Inguinal Lymphadenectomy	Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy	Removal of inguinal nodes using Open radical inguinal lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Ability to recruit patients	18 months	Ability to recruit patients at the selected sites (recruitment rate)

Trial Locations

Locations (1)

University College London; 🇬🇧 London, United Kingdom