search
Back to results

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

Primary Purpose

Vulvar Cancer, Groin Node

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PlasmaJet
Sponsored by
Royal Surrey County Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Cancer focused on measuring vulvar cancer, groin node dissection, bilateral groin node dissection, lymphedema, lymphocyst, lymphorrea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Surgery without trial (PJ) device

Surgery with trial (PJ) device

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with treatment-related adverse events
To document the side-effect profile post-operatively following surgery with the PJ device.
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
Wound Infection
Rate of wound infection following standard surgery vs PlasmaJet use in the groins will be assessed
Length of Stay
Length of hospital stay following surgery will be recorded as well as any readmissions
Lymphedema using the CTC V3.0 grading system
Grade of lymphedema to be assessed at each clinic visit for two years following surgery

Full Information

First Posted
February 11, 2019
Last Updated
September 26, 2019
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT04105465
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Conflict with another study that was opened to recruitment
Study Start Date
July 2013 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Surrey County Hospital NHS Foundation Trust

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer, Groin Node
Keywords
vulvar cancer, groin node dissection, bilateral groin node dissection, lymphedema, lymphocyst, lymphorrea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
A double blind system was applied. Since randomisation was performed in theatre, the patient was unaware of the side that the PJ device was applied. This was not mentioned in the operation notes either. As a result, the nursing team on the inpatient ward were also blinded to the randomisation.
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery without trial (PJ) device
Arm Type
No Intervention
Arm 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.
Arm Title
Surgery with trial (PJ) device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PlasmaJet
Intervention Description
The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications
Primary Outcome Measure Information:
Title
Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Description
To document the side-effect profile post-operatively following surgery with the PJ device.
Time Frame
Upto 1 year following surgery
Title
Risk of groin lymphorrea/ lymphocyst formation using daily drain outputs
Description
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
Time Frame
Upto 1 year following surgery
Title
Wound Infection
Description
Rate of wound infection following standard surgery vs PlasmaJet use in the groins will be assessed
Time Frame
Upto 3months following surgery or till groins healed whichever is sooner
Title
Length of Stay
Description
Length of hospital stay following surgery will be recorded as well as any readmissions
Time Frame
Until 14 days following surgery
Title
Lymphedema using the CTC V3.0 grading system
Description
Grade of lymphedema to be assessed at each clinic visit for two years following surgery
Time Frame
Upto two years following study entry

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women undergoing BGND during their treatment pathway for histologically confirmed vulval cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thumuluru K Madhuri, MD
Organizational Affiliation
Royal Surrey County Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No patient indentifiable data will be shared however anonymised data can be made available on request

Learn more about this trial

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

We'll reach out to this number within 24 hrs