To Evaluate Plasmajet in Achieving Complete Cytoreduction of Advanced EOC- Initial Feasibility Study

Not Applicable

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Device: Surgery for EOC with trial (PJ) device (PlasmaJet)

• Registration Number: NCT02376231
• Lead Sponsor: Dr Thumuluru Kavitha Madhuri

Brief Summary

Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix) and any other tissues involved with cancer. Several studies worldwide have reported that women survive longer and enjoy a longer disease free interval before their disease returns if all visible disease is removed at the time of their surgery. Achieving this is not easy and often there is widespread disease and the surgeons are unable to remove every tumour nodule present as it is attached to the surface of the bowel, diaphragm and other important Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is heated, it partially or wholly ionizes resulting in high energy particles like ions, electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine jet of neutral argon plasma from the handpiece that has been shown to have the ability to vaporise nodules close to sensitive organs like the bowel. It may offer the potential to treat the tumour nodules close to sensitive areas like the bowel. There have been no studies exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation and ablation. It is similar to conventional surgical devices that are routinely used (called diathermy) to achieve these effects. The PJ however is slightly different in that it may also be used on tissue to vaporise tumour nodules in women with ovarian cancer during surgery though the full extent of this role remains unclear.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-05-31
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-03
• Primary Completion: 2015-12
• Study Completion: 2017-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Imaging+/- Clinical +/- laparoscopic e/o pelvic mass and metastatic disease (FIGO III/IV disease) at presentation.
• Confirmation of malignancy on histological/cytological criteria.
• All women aged 18 or over with newly diagnosed FIGO stage III to Stage IV EOC undergoing surgical treatment.
• All women fit to undergo treatment.
• No synchronous malignancy likely to interfere with comparisons.
• Written and informed patient consent

Exclusion Criteria

• Patient choice
• Patient unfit for any treatment modality
• Patients who are medically unfit for surgery and would only be suitable for chemotherapy.

WITHDRAWAL CRITERIA

• Unforeseen complications in the individual patient will be recorded and then analysed.
• Life threatening situation to the patient, due to any other unrelated complication.
• Patients are free to withdraw from the study at any time with no impact on their care whatsoever.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery with trial (PJ) device	Surgery for EOC with trial (PJ) device (PlasmaJet)	Debulking surgery for EOC with interventional trial device (PJ)

Primary Outcome Measures

Name	Time	Method
Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.	At surgery

Secondary Outcome Measures

Name	Time	Method
Post-operative morbidity	30 days
Overall Survival	5 years
Bowel resection rate	6months
Disease Free Survival	3years
Cost-effectiveness	3years	Measured as an incremental cost per Quality of Life Year (QALY)
Per-operative morbidity	30 days
Stoma formation rate	6 months
Quality of Life	3 years	Quality of life based on validated EORTC questionnaires

Trial Locations

Locations (1)

Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust; 🇬🇧 Guildford, Surrey, United Kingdom