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

NCT04105465 | Terminated DMC

• 1 other identifier: PJBGNDRSCH
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Cancer; Groin Node

Keywords

vulvar cancer; groin node dissection; bilateral groin node dissection; lymphedema; lymphocyst; lymphorrea

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (5)

• Number of participants with treatment-related adverse events

  Upto 1 year following surgery

• Risk of groin lymphorrea/ lymphocyst formation using daily drain outputs

  Upto 1 year following surgery

• Wound Infection

  Upto 3months following surgery or till groins healed whichever is sooner

• Length of Stay

  Until 14 days following surgery

• Lymphedema using the CTC V3.0 grading system

  Upto two years following study entry

Study Arms (2)

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.

Device: PlasmaJet

Interventions

PlasmaJet DEVICE

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

Surgery with trial (PJ) device

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women undergoing BGND during their treatment pathway for histologically confirmed vulval cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

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

Guildford, Surrey, GU2 7XX, United Kingdom

Location

MeSH Terms

Conditions

Vulvar Neoplasms; Lymphedema; Lymphocele

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Cysts

Study Officials

• Thumuluru K Madhuri, MD

  Royal Surrey County Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Fellow

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: September 26, 2019
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)