VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

Melanoma Clinical Trial

— VELRAD  

Official title:

Videoendoscopic Radical Inguinal Lymphadenectomy Versus Open Radical Inguinal Lymphadenectomy in Patients With Penile Cancer: a Feasibility Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592639
• Other study ID #: 130062
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2023
• Source: University College, London
• Contact: Anvi Wadke
• Phone: +442079074687
• Email: A.wadke[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphadenopathy
• Melanoma
• Penile Cancer
• Penile Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (4)

Lead Sponsor	Collaborator
University College, London	Norfolk and Norwich University Hospitals NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to recruit patients	Ability to recruit patients at the selected sites (recruitment rate)	18 months