Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University College, London
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Ability to recruit patients
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Videoendoscopic Inguinal Lymphadenectomy
Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy
Intervention: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy (Procedure)
Open Inguinal Lymphadenectomy
Removal of inguinal nodes using Open radical inguinal lymphadenectomy
Intervention: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy (Procedure)
Outcomes
Primary Outcomes
Ability to recruit patients
Time Frame: 18 months
Ability to recruit patients at the selected sites (recruitment rate)
Secondary Outcomes
No secondary outcomes reported