VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer (VELRAD)

University College London (UCL)

Status: Active, not recruiting

Conditions: Inguinal Lymphadenopathy; Melanoma; Penile Cancer

Treatments: Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05592639

130062

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Videoendoscopic Inguinal Lymphadenectomy

Active Comparator group

Description:

Removal of inguinal nodes using Videoendoscopic Inguinal Lymphadenectomy

Treatment:

Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy

Open Inguinal Lymphadenectomy

Other group

Description:

Removal of inguinal nodes using Open radical inguinal lymphadenectomy

Treatment:

Procedure: Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy