Clinical trial · Interventional
VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer
Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial
NCT05592639CI-TRIAL-00089802VELRADactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inguinal Lymphadenopathy | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Videoendoscopic Inguinal Lymphadenectomy
- description
- Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy
- interventionNames
- Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy
- type
- OTHER
- label
- Open Inguinal Lymphadenectomy
- description
- Removal of inguinal nodes using Open radical inguinal lymphadenectomy
- interventionNames
- Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy
Primary outcomes (1)
- measure
- Ability to recruit patients
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTang 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. PMID 38600541