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

Vulvar Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04105465
• Other study ID #: PJBGNDRSCH
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2019
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Groin Node
• Lymphadenopathy
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust	Guildford	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment		24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of Stay	Length of hospital stay following surgery will be recorded as well as any readmissions	Until 14 days following surgery
Secondary	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