VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

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VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	Male

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05592639
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University College, London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Asif Muneer, MD
Principal Investigator Affiliation	University College, London
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Penile Cancer, Inguinal Lymphadenopathy, Melanoma

Additional Details

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

Arms & Interventions

Arms

Active Comparator: Videoendoscopic Inguinal Lymphadenectomy

Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy

Other: Open Inguinal Lymphadenectomy

Removal of inguinal nodes using Open radical inguinal lymphadenectomy

Interventions

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.

Contact a Trial Team

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International Sites

University College London, London 2643743, London, United Kingdom

Status

Address

University College London

London 2643743, London, NW1 2BU

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