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

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.

Study Overview

• Status: Terminated
• Conditions: Vulvar Cancer; Groin Node
• Intervention / Treatment: Device: PlasmaJet

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
      • Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
ACTIVE_COMPARATOR: 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.	Device: PlasmaJet; The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	To document the side-effect profile post-operatively following surgery with the PJ device.	Upto 1 year following surgery
Risk of groin lymphorrea/ lymphocyst formation using daily drain outputs	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	Upto 1 year following surgery
Wound Infection	Rate of wound infection following standard surgery vs PlasmaJet use in the groins will be assessed	Upto 3months following surgery or till groins healed whichever is sooner
Length of Stay	Length of hospital stay following surgery will be recorded as well as any readmissions	Until 14 days following surgery
Lymphedema using the CTC V3.0 grading system	Grade of lymphedema to be assessed at each clinic visit for two years following surgery	Upto two years following study entry

Collaborators and Investigators

• Sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Thumuluru K Madhuri, MD, Royal Surrey County Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2013
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (ACTUAL): September 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: lymphedema; vulvar cancer; groin node dissection; bilateral groin node dissection; lymphocyst; lymphorrea
• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Vulvar Diseases; Vulvar Neoplasms; Lymphadenopathy
• Other Study ID Numbers: PJBGNDRSCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No patient indentifiable data will be shared however anonymised data can be made available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No