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

NCT ID: NCT04105465

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-12-31

Brief Summary

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.

Detailed 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.

Conditions

Vulvar Cancer; Groin Node

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Surgery without trial (PJ) device

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Surgery with trial (PJ) device

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.

Group Type: ACTIVE_COMPARATOR

PlasmaJet

Intervention Type: DEVICE

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

Interventions

PlasmaJet

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Surrey County Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Dr Thumuluru Kavitha Madhuri

Senior Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thumuluru K Madhuri, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Surrey County Hospitals NHS Foundation Trust

Locations

Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

PJBGNDRSCH

Identifier Type: -

Identifier Source: org_study_id