Active not recruitingNAINTERVENTIONAL

VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

This study is exploring a new way to remove lymph nodes in the groin for men with penile cancer. Traditionally, this is done with open surgery, but a new keyhole method, called videoendoscopic radical inguinal lymphadenectomy (VEIL), might cause fewer problems for patients afterwards. This study isn't actually testing which surgery is better yet. Instead, it's a first step to see if it's even possible to run a larger comparison study in the future. Researchers want to find out how many men would be willing to try the new keyhole technique and how easy it would be for hospitals to offer it. This will help them design a bigger study later if this one shows it's a good idea.

At a glance

Status

Active not recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

23 Jun 2022

Estimated completion

01 Jul 2025

Penile Cancer Inguinal Lymphadenopathy Melanoma

What is this study about?

This study is about finding the best way to treat penile cancer, specifically when it has spread to the lymph nodes in the groin. Lymph nodes are small, bean-shaped glands that are part of your body's immune system. If cancer cells spread to these nodes, they usually need to be removed.

There are two main ways to remove these lymph nodes: the traditional "open" surgery, which involves a larger cut, and a newer "keyhole" technique called videoendoscopic radical inguinal lymphadenectomy (VEIL). Doctors think the keyhole method might cause fewer problems, like infections or wound healing issues, after the operation. However, we need to be sure it's just as good at removing the cancer.

What's important to understand is that this current study isn't directly comparing how well these two surgeries work or how many problems they cause. Instead, it's a 'feasibility study.' This means researchers are trying to work out if it would be practical to run a much larger, more detailed study in the future. They want to see how many patients would be happy to take part in such a study, how easy it is for doctors to offer the new keyhole surgery, and whether the study design makes sense. The results of this study will help them plan that bigger, more advanced research if everything looks promising.

Key takeaways

This study is about penile cancer and groin lymph nodes.
It's looking at a keyhole surgery method versus traditional open surgery.
The main goal is to see if a bigger comparison study is possible.
It aims to find out if patients would be open to the new keyhole technique.
This research could help improve future treatments for penile cancer.

Who may be eligible?

This study is looking for men aged 18 or over who need to have lymph nodes removed from their groin because of penile cancer or other genitourinary cancers that affect the male genitals.

You might be considered if your penile cancer is a certain type or stage, or if you've already had some initial tests or treatments like a biopsy that showed cancer in your lymph nodes. It also includes men who couldn't have a special test called a dynamic sentinel node biopsy or who had one that didn't show clearly. If you have small, movable lumps in your groin area, you might also be suitable.

However, you wouldn't be able to join if you're not well enough for surgery, if your cancer is very advanced and removing these nodes wouldn't help, or if the lumps in your groin are large and stuck to your skin or other parts of your body. Of course, if you don't want to take part or can't understand what's involved to give your permission, you won't be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or older?
Do you need surgery to remove lymph nodes in your groin?
Is this related to penile cancer or another male genital cancer?
Are you generally well enough to have surgery?
Are the lumps in your groin not large and stuck to your skin?

Answer every question to see your result.

What does participation involve?

This study focuses on understanding if a future large study is possible, rather than directly comparing treatments. If you qualify and choose to take part, you would be asked about your experiences and thoughts on the study design and the surgery options. You wouldn't be randomly assigned to receive a particular type of surgery in *this* feasibility study; rather, researchers are gathering information to help design that future trial. The total duration of your involvement would depend on the assessments and follow-up needed for this information gathering phase.

Potential risks and benefits

Potential benefits could include contributing valuable information that helps shape future care for men with penile cancer, potentially leading to less invasive and safer surgical options. There are no direct personal medical benefits offered by participating in this particular feasibility study beyond standard care. Potential risks are generally low, as the study focuses on gathering information and feedback rather than an experimental treatment. However, all medical procedures carry some risks, which your doctor will discuss with you. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London
Verified postcode
London, United Kingdom

Common questions

What is 'lymphadenectomy'?

It's a surgery to remove lymph nodes, which are small glands that can hold cancer cells.

What's the difference between open and videoendoscopic surgery?

Open surgery involves a larger cut, while videoendoscopic (keyhole) surgery uses smaller cuts and special instruments with a camera.

Will I get the new surgery if I join this study?

This study isn't about giving you a specific surgery, but about gathering information to help design a future study that might compare them.

Why is this study needed?

It helps researchers see if it's practical to run a bigger study on a new keyhole surgery technique that might be better for patients in the future.

Who is running this study?

Patient.info does not conduct clinical trials. This information is a summary for a trial that you would discuss with your doctor if it were relevant for you.