Adjuvant Use of PlasmaJet Device During Cytoreductive Surgery for Advanced-Stage Ovarian Cancer: Results of the PlaComOv-study, a Randomized Controlled Trial in The Netherlands

Boer, Gatske M. Nieuwenhuyzen-de; Hofhuis, Ward; Reesink-Peters, Nathalie; Willemsen, Sten P.; Boere, Ingrid; Schoots, IG; Piek, Jurgen M.J.; Hofman, Laura; Beltman, Jogchum Jan; Driel, Willemien J. van; Werner, HM; Baalbergen, Astrid; Jong, A.M.L.D. Van Haaften-de; Dorman, M C; Haans, Lucien; Nedelcu, Iulia Daniela; Ewing‐Graham, Patricia C.; Beekhuizen, Heleen J. van

doi:10.1245/s10434-022-11763-2

Cited by 12 publications

(16 citation statements)

References 34 publications

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“…However, only the absence of ascites and peritoneal carcinomatosis during surgery, FIGO stage IIIB/IIIC and serious histology were the significant independent predictors of complete interval CRS as presented in multivariable analysis. Furthermore, use of the PlasmaJet surgical device was an independent predictor of complete CRS, which is in line with the results of the PlaComOv study [ 12 , 28 ].…”

Section: Discussionsupporting

confidence: 87%

“…The extent of surgery required to achieve the outcome was also documented. These results can be found in the original article of the PlaComOv-study [ 28 ].…”

Section: Resultsmentioning

confidence: 76%

“…All variables in the univariable analysis were selected for the multivariable logistic regression to identify all independent predictors of complete CRS. The use of the PlasmaJet surgical device, which has been reported to increase the rate of complete CRS [ 28 ], was evenly distributed among all groups.…”

Section: Discussionmentioning

confidence: 99%

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Preoperative Cancer Antigen 125 Level as Predictor for Complete Cytoreduction in Ovarian Cancer: A Prospective Cohort Study and Systematic Review

Brons

Boer

Ramakers

et al. 2022

Cancers

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Background: The tumor marker ‘cancer antigen 125’ (CA-125) plays a role in the management of women with advanced stage ovarian cancer. This study aims to describe the predictive value of pre-treatment CA-125 level and the reduction after neoadjuvant chemotherapy (NACT) on surgical outcome. Methods: A systematic review and a prospective clinical study were performed. Multiple databases were searched from database inception to April 2022. The clinical study is part of a randomized controlled trial named “PlaComOv-study”. A regression analysis was performed to demonstrate correlations between preoperative CA-125 levels, CA-125 reduction after NACT, and surgical outcome. Results: Fourteen relevant articles were analyzed of which eleven reported that lower preoperative CA-125 levels were associated with a higher probability of complete cytoreduction. In the clinical study, 326 patients with FIGO stage IIIB-IV ovarian cancer who underwent CRS were enrolled from 2018 to 2020. Patients who underwent interval CRS with preoperative CA-125 levels ≤ 35 kU/L had higher odds of achieving complete CRS than patients with CA-125 level >35 kU/L (85% vs. 67%, OR 2.79, 95%CI 1.44–5.41, p = 0.002). In multivariable analysis with presence of ascites and peritoneal carcinomatosis, normalized preoperative CA-125 did not appear as a significant predictor for complete CRS. Conclusions: In literature, preoperative CA-125 levels ≤ 35 kU/L were associated with a significant higher percentage of complete CRS in univariable analysis. According to our cohort study, preoperative CA-125 level ≤ 35 kU/L cannot independently predict surgical outcome either for primary or interval CRS.

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Section: Discussionsupporting

confidence: 87%

“…The extent of surgery required to achieve the outcome was also documented. These results can be found in the original article of the PlaComOv-study [ 28 ].…”

Section: Resultsmentioning

confidence: 76%

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Preoperative Cancer Antigen 125 Level as Predictor for Complete Cytoreduction in Ovarian Cancer: A Prospective Cohort Study and Systematic Review

Brons

Boer

Ramakers

et al. 2022

Cancers

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“…In clinical practice, the effect of less tissue infiltration by using the PlasmaJet may also be reflected in the quality of life. Patients who had surgery using the PlasmaJet showed a higher quality of life six months after the procedure [ 17 ]. A possible explanation could be that less tissue damage results in a different process of tissue repair and regeneration (inflammation, proliferation by fibrogenesis and angiogenesis and remodeling).…”

Section: Resultsmentioning

confidence: 99%

The effects of neutral argon plasma versus electrocoagulation on tissue in advanced-stage ovarian cancer: a case series

et al. 2022

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Background The aim of surgery for advanced-stage ovarian cancer is a complete cytoreduction, because this is the most important independent prognostic factor for prolonged survival. Yet this can be difficult to achieve when there are micrometastases on the intestinal mesentery or intestines. The PlasmaJet device is an instrument to remove these micrometastases, but little is known about the depth of damage in human tissue compared to electrocoagulation devices. Methods A prospective study was performed for the ex-vivo comparison of the histological depth of thermal damage of neutral argon plasma (PlasmaJet®) and electrocoagulation devices, in a series of 106 histological slides of 17 advanced-stage ovarian cancer patients. Depending on the tissue types resected during complete cytoreductive surgery, samples were collected from reproductive organs (uterus, ovaries), intestines (ileum, colon, rectum) and omentum, intestinal mesentery and peritoneum. Results Average thermal damage depth was 0.15 mm (range 0.03–0.60 mm) after use of neutral argon plasma and 0.33 mm (range 0.08–1.80 mm) after use of electrocoagulation (p < 0.001). Greater disruption of the tissue surface was often observed after electrocoagulation. Conclusion Our case series suggests that the use of neutral argon plasma during cytoreductive surgery produces significantly less thermal damage than electrocoagulation treatment. It is therefore considered a thermally safe alternative, aiding in the achievement of cytoreductive surgery.

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“…One of the additional options during surgery is the possibility to use Neutral Argon Plasma (PlasmaJet Surgical Device of Plasma Surgical, Inc, Roswell, GA), which increases the number of complete cytoreductions. 6 Even previous studies showed that the adjuvant use of the PlasmaJet during CRS for advanced-stage EOC resulted in a significantly higher percentage of complete CRS compared with conventional treatment without the use of the PlasmaJet. [7][8][9][10] The costs of treatment of advanced-stage ovarian cancer can range from V20,000 for only surgery up to V200, 000 and even higher for treatment with both surgery and chemotherapy.…”

Section: Introductionmentioning

confidence: 97%

Cost Study of the PlasmaJet Surgical Device Versus Conventional Cytoreductive Surgery in Patients With Advanced-Stage Ovarian Cancer

Boer

Geraerds

Linden

et al. 2022

JCO Clinical Cancer Informatics

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PURPOSE Adjuvant use of Neutral Argon Plasma (PlasmaJet Surgical Device) during cytoreductive surgery (CRS) for advanced-stage epithelial ovarian cancer improves surgical outcomes. The aim of this study is to examine the costs of adjuvant use of the PlasmaJet during surgery compared with conventional CRS in advanced-stage epithelial ovarian cancer. MATERIALS AND METHODS The patients were randomly assigned to surgery with or without the PlasmaJet. Analysis of the intra- and extramural health care costs was performed. Costs were divided into three categories: costs of the diagnostic phase (T1), inpatient care up to discharge including costs of surgery (T2), and outpatient care including chemotherapy until 6 weeks after the last cycle of chemotherapy (T3). RESULTS Overall, 327 patients underwent CRS (surgery with PlasmaJet: n = 157; conventional surgery: n = 170). The mean total health costs were significantly higher for CRS with adjuvant use of PlasmaJet compared with conventional CRS (€19,414 v €18,165, P = .017). Costs are divided into costs of the diagnostic phase (€2,034 v €1,974, P = .890), costs of inpatient care (€10,956 v €9,556, P = .003), and costs of outpatient care (€6,417 v €6,628, P = .147). CONCLUSION Mean total health care costs of the use of PlasmaJet in CRS were significantly higher than those for conventional CRS. This difference is fully explained by the additional surgery costs of the use of PlasmaJet. However, surgery with the use of the PlasmaJet leads to a significantly higher percentage of complete CRS and a halving of stomas. A cost-effectiveness analysis will be performed once survival data are available (funded by ZonMw, Trial Register NL62035.078.17).

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Adjuvant Use of PlasmaJet Device During Cytoreductive Surgery for Advanced-Stage Ovarian Cancer: Results of the PlaComOv-study, a Randomized Controlled Trial in The Netherlands

Cited by 12 publications

References 34 publications

Preoperative Cancer Antigen 125 Level as Predictor for Complete Cytoreduction in Ovarian Cancer: A Prospective Cohort Study and Systematic Review

Preoperative Cancer Antigen 125 Level as Predictor for Complete Cytoreduction in Ovarian Cancer: A Prospective Cohort Study and Systematic Review

The effects of neutral argon plasma versus electrocoagulation on tissue in advanced-stage ovarian cancer: a case series

Cost Study of the PlasmaJet Surgical Device Versus Conventional Cytoreductive Surgery in Patients With Advanced-Stage Ovarian Cancer

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