Vulvar CancerNCT04105465
Study to Evaluate the Role of PlasmaJet in Patients Undergoing Groin Node Dissection for Vulval Cancer
A study testing PlasmaJet in people with Vulvar Cancer and Groin Node, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Cancer, Groin Node
- What is being tested?
- PlasmaJet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, GU2 7XX
About this study
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
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.
Read the 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.
- Conditions
- Vulvar Cancer, Groin Node
- Being tested
- PlasmaJet
- Keywords
- vulvar cancer, groin node dissection, bilateral groin node dissection, lymphedema, lymphocyst, lymphorrea
- Medical subject headings
- Vulvar Neoplasms, Lymphedema, Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaJetDevice
The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications
| Study group | Role | What they receive |
|---|---|---|
| Surgery without trial (PJ) device | No intervention | 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. |
| Surgery with trial (PJ) device | Active comparator | 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. Receives: Device: PlasmaJet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment
Measured: 24 months
Secondary outcomes (5)
Number of participants with treatment-related adverse events
To document the side-effect profile post-operatively following surgery with the PJ device.
Measured: 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
Measured: Upto 1 year following surgery
Wound Infection
Rate of wound infection following standard surgery vs PlasmaJet use in the groins will be assessed
Measured: 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
Measured: 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
Measured: Upto two years following study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startJul 2013
- Primary completionJul 2016
- Study completionDec 2016
Why it stopped: Conflict with another study that was opened to recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Thumuluru Kavitha Madhuri, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Thumuluru K Madhuri, MD, Principal investigator, Royal Surrey County Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105465
- Sponsor's protocol ID
- PJBGNDRSCH
- Status last verified
- Sep 2019
- First submitted
- 11 Feb 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No patient indentifiable data will be shared however anonymised data can be made available on request
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04105465
- Acronym / sponsor ID
- PJBGNDRSCH
- Conditions
- Vulvar Cancer, Groin Node
- Keywords
- vulvar cancer, groin node dissection, bilateral groin node dissection, lymphedema, lymphocyst, lymphorrea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Conflict with another study that was opened to recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surgery without trial (PJ) device | No intervention | –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. |
| Surgery with trial (PJ) device | Active comparator | Device: PlasmaJetUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasmaJetThe PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications | Device | Surgery with trial (PJ) device |
Primary outcome
Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment
Time frame: 24 months
5 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: Upto 1 year following surgery
Risk of groin lymphorrea/ lymphocyst formation using daily drain outputs
Time frame: Upto 1 year following surgery
Wound Infection
Time frame: Upto 3months following surgery or till groins healed whichever is sooner
Length of Stay
Time frame: Until 14 days following surgery
Lymphedema using the CTC V3.0 grading system
Time frame: Upto two years following study entry
Results and safety
The study was stopped early (reason given: Conflict with another study that was opened to recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No. No patient indentifiable data will be shared however anonymised data can be made available on request
Related trials for Vulvar Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruiting
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
Vulvar Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruiting
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Malignant Female Reproductive System Neoplasm, Stage III Cervical Cancer AJCC v8
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thumuluru K Madhuri, MD principal investigator
Royal Surrey County Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlasmaJet in people with Vulvar Cancer and Groin Node, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Conflict with another study that was opened to recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment into the pilot study.The rate (% and absolute rate) of recruitment (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.