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Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

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Hemostatics

All steps of surgery are conducted as per standard practice in accordance with the current practice at the time. In all cases a bilateral inguino-femoral groin node dissection was performed, with en-bloc removal of the superficial and deep inguinal nodes with conservation of the long saphenous vein.

Use of the PJ was limited to the randomised side only. All steps of surgery are conducted as per standard practice in accordance with the current practice at the time. In all cases a bilateral inguino-femoral groin node dissection was performed, with en-bloc removal of the superficial and deep inguinal nodes with conservation of the long saphenous vein. Haemostasis was ensured with diathermy and ties and just prior to wound closure, the surgeon used the PlasmaJet on the indicated groin to seal the lymph vessels and channels at a setting of 40% by spraying the argon plasma over the entire exposed surgical field at a distance of 10 mm from the surface to the tip of the instrument.

The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications

PlasmaJet

Thumuluru K Madhuri, MD

Surgery for vulvar cancer involves removal of the central tumour as well as groin node dissection as indicated depending on the stage of tumour. Groin node dissection is associated with significant complications including lymphorrea, lymphocyst formation, wound breakdown as well as long term complications including lymphedema.

This study has been designed with each patient acting as their own control to investigate if using the PlasmaJet during surgery is associated with a reduction in the above mentioned complications.

Vulvar malignancy is the fourth most common malignancy of the female genital tract. Surgical excision achieves excellent local control and remains the mainstay of treatment.

Surgical excision depends on the extent of disease and may be in the form of wide local excision or radical vulvectomy. Lymphadenectomy in the form of bilateral groin node dissection (BGND) is performed for all central tumors with depth of invasion greater than 1 mm, unless there is significant comorbidity contraindicating this, but is known to cause significant postoperative morbidity. Immediate postoperative complications include breakdown and lymphocyst formation in more than 50% of cases. The PlasmaJet is a novel device that produces a jet of pure argon plasma by heating pressurized argon gas. Energy from the argon plasma transfers to tissue as light, heat, and kinetic energy.

Following ethical approval, a prospective, crossover, doubleblind, randomized, control trial to assess the PJ system, with the primary outcome being the possibility of reduction in wound breakdown and lymphocyst and lymphedema formation following BGND for vulvar cancer was opened.

The trial design was conceived as a single site, double blind, crossover study in which each patient would be their own control would offer the most useful information.

A double blind system was applied. Since randomisation was performed in theatre, the patient was unaware of the side that the PJ device was applied. This was not mentioned in the operation notes either. As a result, the nursing team on the inpatient ward were also blinded to the randomisation.

Women undergoing BGND during their treatment pathway for histologically confirmed vulval cancer

Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer

Randomised,Crossover, Feasibility Study to Evaluate the PlasmaJet in the Management of Lymphedema and Lymphocyst Formation in Patients Undergoing Bilateral Groin Node Dissection (BGND) for Vulval Cancer

No patient indentifiable data will be shared however anonymised data can be made available on request

To document the side-effect profile post-operatively following surgery with the PJ device.

To explore the potential and safety of the PJ device in the prevention of groin lymphocyst formation by prophylactic coagulation of lymph vessels in patients undergoing BGND for vulval cancer

Rate of wound infection following standard surgery vs PlasmaJet use in the groins will be assessed

Length of hospital stay following surgery will be recorded as well as any readmissions

Grade of lymphedema to be assessed at each clinic visit for two years following surgery

Royal Surrey County Hospital NHS Foundation Trust

Senior Clinical Fellow

Symptoms and General Pathology

Neoplasm Metastasis

Lymphatic Metastasis

Neoplastic Processes

Interventional Treatment: serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months (n=13).

Standard Treatment: receive upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).

Participants with suspicious/indeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines.

Participants in the Interventional Treatment (serial ultrasounds) group will undergo surgical excision of the primary tumor, either via radical wide local excision or radical vulvectomy. Post-vulvar surgery, follow-up appointments occur bi-monthly for 12 months, involving a clinical examination and groin ultrasound. Senior imaging specialists review bilateral ultrasound scans for positive lymph nodes or suspicious findings, promptly sending reports to the primary care physician and trial manager if detected within 3 business days. Subsequently, participants consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with bi-monthly ultrasounds based on preference and clinician guidance.

High-resolution bilateral groin ultrasound surveillance

Sara Baniahmadi

Avalon Knott

Andreas Obermair, Prof

Andrea Garrett, Dr

This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months.

Treatment of vulvar cancer causes significant morbidity. Despite being a rare cancer, at least 2500 survivors of vulvar cancer live in Australia. Most survivors live with the detrimental, life-long impacts resulting from their cancer treatment because there are currently no alternatives to mitigate these impacts. The personal and societal burden this entails is significant. To control such cancer-associated burden is a national priority.

Clinical palpation of the groin region and computed tomography (CT) scans do not reliably detect groin node involvement. Hence, current clinical guidelines recommend all women diagnosed at apparent Stage I or II have a surgical groin LND. This can be performed as a full IFL (full LND) to remove all groin nodes, or as a SNB to remove selected (one or two) nodes. SNB is less invasive, however, is appropriate only for vulvar cancers \<4cm in diameter and unifocal tumours (\~50% of all Stage I and II vulvar cancers). SNB is also associated with a false negative rate (10%) that increases the risk of undetected nodes.

In 25% of cases (\~80 Australian women per year), groin LND will reveal positive nodes (i.e., metastases), which triggers a referral for radiation treatment. If positive groin nodes are missed, and over time become enlarged, clinically palpable and attached to the overlying skin, \>90% of women will die within 12 months, despite subsequent treatment. Conversely, if groin node involvement is detected early (e.g., by ultrasound) while still small, survival outcomes are excellent. Ultrasound technology is potentially as accurate as LND due to recent advances in resolution and technologies such as 2D/3D volumetric assessments and tissue flow. Furthermore, ultrasound is superior to medical resonance imaging (MRI), and to standard CT and positron emission tomography (PET) scans in capturing groin node involvement because it has a higher resolution, avoids harmful radiation and the technology is readily accessible outside of high-volume metropolitan areas.

The investigators propose to reduce surgical morbidity by replacing upfront groin LND for vulvar cancer patients with serial high-resolution ultrasound to detect groin metastases. Groin LND will only be necessary for the few women with ultrasound-detected metastases when they are still small. This feasibility study (NODE - groiN ultrasOunD cancer) will determine the value of randomized serial groin ultrasound examinations in stage I and II vulvar cancer patients and whether it is feasible and safe for the investigators to de-escalate the extent of vulvar cancer surgery, aiming to achieve improved outcomes for affected patients.

Australian women with this rare cancer bear an unacceptably high (and potentially avoidable) treatment-related burden. This feasibility study is the first step to address this problem in a novel yet pragmatic way. The overall outcome of NODE is a novel, less invasive alternative to vulvar cancer LND associated with significantly less morbidity, without compromising survival.

Feasibility trial, open label, three-group, randomised clinical trial

30 eligible females aged 18 or older with clinically stage 1b or 2 vulvar cancer will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery:

Participants with normal/negative baseline groin ultrasounds will be randomly assigned to two groups (2:1 randomisation): one group undergoing radical procedures (groin lymph nodes are not removed) with bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months, and the other group undergoing upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).

Participants with suspicious/indeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines.

NODE (groiN ultrasOunD cancEr)

Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Queensland Women With Vulvar Cancer

The feasibility of randomisation into (1) LND (IFL vs SNB) or (2) high-resolution bilateral groin ultrasound surveillance every 2 months will be determined through a practical sample size of n=20. Feasibility is declared if 30% of eligible patients (n=6 or more) can be randomised.

Translational research - Compare the molecular profile of tumour mutations between positive and negative lymph nodes.

Translational research - Compare the molecular profile of circulating tumour DNA between positive and negative lymph nodes.

Translational research - Compare the molecular profile of plasma between positive and negative lymph nodes.

Translational research - Compare the molecular profile of serum between positive and negative lymph nodes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer	NCT04105465	Vulvar Cancer Groin Node	PlasmaJet	18 Years -	Royal Surrey County Hospital NHS Foundation Trust
Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer	NCT04105465	Vulvar Cancer Groin Node	PlasmaJet	18 Years -	Royal Surrey County Hospital NHS Foundation Trust
NODE (groiN ultrasOunD cancEr)	NCT06264167	Vulvar Cancer S... Vulvar Cancer S... Lymph Node Meta... Groin Node Ultrasound Ther...	High-resolution...	18 Years -	Queensland Centre for Gynaecological Cancer

Spots Global Cancer Trial Database for groin node

Every month we try and update this database with for groin node cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for groin node

Every month we try and update this database with for groin node cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for groin node cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.