Clinical trial NCT04105465: Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vulvar Cancer
Groin Node
Keywords: vulvar cancer
groin node dissection
bilateral groin node dissection
lymphedema
lymphocyst
lymphorrea
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment
timeFrame: 24 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: Upto 1 year following surgery
measure: Risk of groin lymphorrea/ lymphocyst formation using daily drain outputs
timeFrame: Upto 1 year following surgery
measure: Wound Infection
timeFrame: Upto 3months following surgery or till groins healed whichever is sooner
measure: Length of Stay
timeFrame: Until 14 days following surgery
measure: Lymphedema using the CTC V3.0 grading system
timeFrame: Upto two years following study entry
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Surrey County Hospitals NHS Foundation Trust
name: Thumuluru K Madhuri, MD
role: PRINCIPAL_INVESTIGATOR
References: