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

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Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment

Secondary Outcome

 Number of participants with treatment-related adverse events

Condition

Vulvar Cancer

Intervention

PlasmaJet

Study Arms / Comparison Groups

 Surgery without trial (PJ) device
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

21

Start Date

July 2013

Completion Date

December 2016

Primary Completion Date

July 2016

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thumuluru K Madhuri, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT04105465

Organization ID

PJBGNDRSCH


Responsible Party

Principal Investigator

Study Sponsor

Royal Surrey County Hospital NHS Foundation Trust


Study Sponsor

Thumuluru K Madhuri, MD, Principal Investigator, Royal Surrey County Hospitals NHS Foundation Trust


Verification Date

September 2019