VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer (VELRAD)
May 13, 2025 updated by: University College, London
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, NW1 2BU
- University College London
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
Time Frame: 18 months
|
Ability to recruit patients at the selected sites (recruitment rate)
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Asif Muneer, MD, University College, London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
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