VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer
NCT ID: NCT05592639
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2022-06-23
2025-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Videoendoscopic Inguinal Lymphadenectomy
Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy
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.
Open Inguinal Lymphadenectomy
Removal of inguinal nodes using Open radical inguinal lymphadenectomy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
MALE
No
Sponsors
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The Christie NHS Foundation Trust
OTHER
St George's University Hospitals NHS Foundation Trust
OTHER
Norfolk and Norwich University Hospitals NHS Foundation Trust
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Asif Muneer, MD
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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University College London
London, London, United Kingdom
Countries
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References
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Tang S, Akers C, Alnajjar H, Ayres B, Baldini C, Embleton-Thirsk A, Gurusamy K, Hadway P, Kumar V, Lau M, Nigam R, Pang K, Parnham A, Pizzo E, Ranieri V, Rees R, Sangar V, Wadke A, Williams N, Muneer A. A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD). Pilot Feasibility Stud. 2024 Apr 10;10(1):61. doi: 10.1186/s40814-024-01474-8.
Other Identifiers
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130062
Identifier Type: -
Identifier Source: org_study_id
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