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

Royal Surrey County Hospital NHS Foundation Trust

Status: Terminated

Conditions: Groin Node; Vulvar Cancer

Treatments: Device: PlasmaJet

Study type: Interventional

Funder types: Other

Identifiers

NCT04105465

PJBGNDRSCH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• To be included in this study, all women should undergo BGND during their treatment pathway for histologically confirmed vulval cancer.
• Participant is willing and able to provide informed consent.
• Aged 18 years or above.
• Participant willing to allow General Practitioner and other health care professionals, if appropriate, to be notified of participation in study.

Exclusion criteria

• Women with vulval cancer who do not undergo BGND.
• Women with any previous groin surgery
• Women with any previous radiotherapy to the pelvic area including the groins
• Patient choice
• Women who are pregnant, lactating or planning pregnancy during the course of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Surgery without trial (PJ) device

No Intervention group

Description:

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.

Surgery with trial (PJ) device

Active Comparator group

Description:

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.

Treatment:

Device: PlasmaJet