NODE

 The NODE study is a randomised feasibility trial comparing groin ultrasound surveillance with groin node surgery in Queensland women with vulvar cancer, aiming to reduce the extent of surgery for this condition.

Vulvar cancer is a rare disease, affecting around 400 women in Australia each year, and develops from the skin of the vulva. It can spread locally to nearby structures (such as the vagina, urethra, and anus) or through lymphatic channels to the lymph nodes in the groin. Lymph nodes are a key part of the immune system, filtering harmful substances, including cancer cells, from the body and helping fight infections.

The standard treatment for vulvar cancer involves surgery to remove the primary tumour and, if needed, the groin lymph nodes—a procedure known as lymph node dissection. This can either be a full dissection, where all the groin nodes are removed, or a sentinel node biopsy (SNB), where only one or two selected nodes are removed.

While lymph node dissection can be effective, it also has significant short- and long-term complications. These include infections, blood buildup (hematoma), fluid buildup (seroma), pain, swelling (edema), and reduced mobility. A more serious complication is lymphedema, where the legs, genitals, and surrounding areas experience chronic swelling. Some patients may also suffer from persistent pain, nerve damage, or difficulty performing everyday activities.

One of the key questions this study aims to address is whether it's necessary to remove groin lymph nodes in cases of early-stage vulvar cancer. It remains unclear whether this procedure improves patient outcomes, making it vital to explore alternatives.

The NODE study will evaluate the feasibility of using serial high-resolution groin ultrasound to monitor for lymph node involvement (the presence of cancer in the groin nodes) in patients with early-stage vulvar cancer. In this approach, groin lymph nodes would only be surgically removed if they appear suspicious or abnormal on ultrasound, rather than being automatically removed. Early detection of cancer in the groin nodes, while still small, is expected to result in excellent survival outcomes. Therefore, identifying enlarged or abnormal groin nodes is crucial for the oncological safety of vulvar cancer patients.

This feasibility study seeks to determine whether randomised serial groin ultrasound examinations are a valuable and safe method for monitoring early-stage vulvar cancer patients and whether it is possible to safely reduce the extent of surgery to improve patient outcomes.