Inguinal Lymphadenopathy, Melanoma, Penile Cancer
Conditions
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
Interventions
PROCEDUREVideoendoscopic 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.
Sponsors
The Christie NHS Foundation Trust
St George's University Hospitals NHS Foundation Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to recruit patients | 18 months | Ability to recruit patients at the selected sites (recruitment rate) |
Countries
United Kingdom
Outcome results
None listed