Evaluation of effectiveness of the PlasmaJet surgical device in the treatment of advanced stage ovarian cancer (PlaComOv-study): study protocol of a randomized controlled trial in the Netherlands

Abstract

BackgroundThe most important goal for survival benefit of advanced stage ovarian cancer is to surgically remove all visible tumour, because complete cytoreductive surgery (CCS) has been shown to be associated with prolonged survival.In a remarkable number of women, CCS is very challenging. Especially in women with many small metastases on the peritoneum and intestinal surface, conventional CCS with electrosurgery is not able to be “complete” in removing safely all visible tumour.In this randomized controlled trail (RCT) we investigate whether the use of the PlasmaJet Surgical Device increases the rate of CCS, and whether this indeed leads to a longer progression free and overall survival.The main research question is: does the use of the PlasmaJet Surgical Device in surgery for advanced stage ovarian cancer result in an increased number of complete cytoreductive surgeries when compared with conventional surgical techniques. Secondary study objectives are: 30-day morbidity, duration of surgery, blood loss, length of hospitalisation, Quality of Life, disease-free survival, overall survival, percentage colostomy, cost-effectiveness.MethodsThe study design is a multicentre single-blinded superiority RCT in two university and nine non-university hospitals in The Netherlands. Three hundred and thirty women undergoing cytoreductive surgery for advanced stage ovarian carcinoma (FIGO Stage IIIB-IV) will be randomized into two arms: use of the PlasmaJet (intervention group) versus the use of standard surgical instruments combined with electrocoagulation (control group). The primary outcome is the rate of complete cytoreductive surgery in both groups.Secondary study objectives are: 30-day morbidity, duration of surgery, blood loss, length of hospitalisation, Quality of Life, disease-free survival, overall survival, percentage colostomy, cost-effectiveness. Quality of life will be evaluated using validated questionnaires at baseline, at 1 and 6 months after surgery and at 1, 2, 3 and 4 years after surgery.DiscussionWe hypothesize the additional value of the use of the PlasmaJet in CCS for advanced stage epithelial ovarian cancer. More knowledge about efficacy, side effects, recurrence rates, cost effectiveness and pathology findings after using the PlasmaJet Device is advocated. This RCT may aid in this void.Trial registrationDutch Trial Register NTR6624. Registered 18 August 2017.Medical Ethical Committee approval number: NL62035.078.17 (Medical Ethical Committee Erasmus Medical Centre Rotterdam).

Effectiveness and safety of the PlasmaJet® Device in advanced stage ovarian carcinoma: a systematic review

“…We have proposed an RCT named PlaComOv-study in which we will compare feasibility, safety and effectiveness aspects of the use of the PlasmaJet® with those of conventional electrosurgery in advanced stage epithelial ovarian cancer (FIGO IIIB-IV) [13]. We hypothesize that the probability of achieving complete cytoreduction is significantly higher in the group of patients randomized to surgery with the use of the PlasmaJet® device.…”

Experience with PlasmaJet™ in debulking surgery in 87 patients with advanced‐stage ovarian cancer

“…Nieuwenhuyzen et al published a study protocol for a multicenter single‐blinded superiority randomized controlled trial involving 11 hospitals in the Netherlands (PlaComOv‐study). Patients with advanced‐stage ovarian cancer will be randomized between debulking surgery using PBS versus treatment with standard surgical instruments and electrocoagulation 29 …”

The Emerging Role of Neutral Argon Plasma (PlasmaJet) in the Treatment of Advanced Stage Ovarian Cancer: A Systematic Review

“…Three studies were excluded from further analysis when they were retrieved in full text. [8][9][10] Among them, Nieuwenhuyzen et al presented the protocol design of a randomized controlled trial for the use of PlasmaJet in ovarian cancer, but no outcomes were recorded and was excluded. 10 Furthermore, the study by Sonoda et al was excluded since PlasmaJet was applied ex vivo following resection of the lesion.…”

“…Recently, Nieuwenhuyzen et al published the design of a study protocol of a randomized controlled trial from 11 hospitals in the Netherlands, which is called PlaComOvstudy. 10 The authors aimed to include 330 patients with stage IIIB-IV ovarian cancer, fallopian, or peritoneal cancer, who were eligible for complete cytoreduction and were randomized according to the application of only electrocoagulation or the supplementary use of PlasmaJet. 10 The rate of the complete cytoreduction in each group has been set as the primary outcome.…”

“…10 The authors aimed to include 330 patients with stage IIIB-IV ovarian cancer, fallopian, or peritoneal cancer, who were eligible for complete cytoreduction and were randomized according to the application of only electrocoagulation or the supplementary use of PlasmaJet. 10 The rate of the complete cytoreduction in each group has been set as the primary outcome. Similarly, another randomized controlled trial has been recruited by Madhuri et al in 2013 (NCT02376231) with the intent to assess the efficacy of neutral argon plasma in achieving complete cytoreduction compared with conventional surgery without the use of the device.…”