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Trial Title:
VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer
NCT ID:
NCT05592639
Condition:
Penile Cancer
Inguinal Lymphadenopathy
Melanoma
Conditions: Official terms:
Penile Neoplasms
Lymphadenopathy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Videoendoscopic radical inguinal lymphadenectomy or open radical inguinal lymphadenectomy
Description:
Intervention is a Videoendoscopic radical inguinal lymphadenectomy (VEIL) which is a
surgical technique utilised in removing inguinal lymph nodes.
Arm group label:
Open Inguinal Lymphadenectomy
Arm group label:
Videoendoscopic Inguinal Lymphadenectomy
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
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University College London
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Anvi Wadke
Email:
sig.velrad@ucl.ac.uk
Investigator:
Last name:
Asif Muneer, MD
Email:
Principal Investigator
Investigator:
Last name:
Stanley Tang, BMBS
Email:
Sub-Investigator
Start date:
June 23, 2022
Completion date:
August 1, 2024
Lead sponsor:
Agency:
University College, London
Agency class:
Other
Collaborator:
Agency:
The Christie NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
St George's University Hospitals NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Agency class:
Other
Source:
University College, London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05592639
