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

G M Nieuwenhuyzen-de Boer; W Hofhuis; N Reesink-Peters; S Willemsen; I A Boere; I G Schoots; J M J Piek; L N Hofman; J J Beltman; W J van Driel; H M J Werner; A Baalbergen; A M L D van Haaften-de Jong; M Dorman; L Haans; I Nedelcu; P C Ewing-Graham; H J van Beekhuizen

doi:10.1245/s10434-022-11763-2

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

G M Nieuwenhuyzen-de Boer^*, W Hofhuis, N Reesink-Peters, S Willemsen, I A Boere, I G Schoots, J M J Piek, L N Hofman, J J Beltman, W J van Driel, H M J Werner, A Baalbergen, A M L D van Haaften-de Jong, M Dorman, L Haans, I Nedelcu, P C Ewing-Graham, H J van Beekhuizen

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVE: Standard surgical treatment of advanced-stage ovarian carcinoma with electrosurgery cannot always result in complete cytoreductive surgery (CRS), especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of a neutral argon plasma device can help increase the complete cytoreduction rate.

PATIENTS AND METHODS: 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were randomized to either surgery with neutral argon plasma (PlasmaJet) (intervention) or without PlasmaJet (control group). The primary outcome was the percentage of complete CRS. The secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30-day morbidity, and quality of life (QoL).

RESULTS: Complete CRS was achieved in 119 patients (75.8%) in the intervention group and 115 patients (67.6%) in the control group (risk difference (RD) 8.2%, 95% confidence interval (CI) -0.021 to 0.181; P = 0.131). In a per-protocol analysis excluding patients with unresectable disease, complete CRS was obtained in 85.6% in the intervention group and 71.5% in the control group (RD 14.1%, 95% CI 0.042 to 0.235; P = 0.005). Patient-reported QoL at 6 months after surgery differed between groups in favor of PlasmaJet surgery (95% CI 0.455-8.350; P = 0.029). Other secondary outcomes did not differ significantly.

CONCLUSIONS: Adjuvant use of PlasmaJet during CRS for advanced-stage ovarian cancer resulted in a significantly higher proportion of complete CRS in patients with resectable disease and higher QoL at 6 months after surgery. (Funded by ZonMw, Trial Register NL62035.078.17.) TRIAL REGISTRATION: Approved by the Medical Ethics Review Board of the Erasmus University Medical Center Rotterdam, the Netherlands, NL62035.078.17 on 20-11-2017. Recruitment started on 30-1-2018.

Original language	English
Pages (from-to)	4833-4843
Number of pages	11
Journal	Annals of Surgical Oncology
Volume	29
Issue number	8
Early online date	13 May 2022
DOIs	https://doi.org/10.1245/s10434-022-11763-2
Publication status	Published - Aug 2022

Keywords

ACHIEVING COMPLETE CYTOREDUCTION
CARCINOMA
ENERGY
IMPACT
NEOADJUVANT CHEMOTHERAPY
NEUTRAL ARGON PLASMA
PRIMARY DEBULKING SURGERY
RESECTION
RESIDUAL DISEASE
TUMOR

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Boer, G. M. N., Hofhuis, W., Reesink-Peters, N., Willemsen, S., Boere, I. A., Schoots, I. G., Piek, J. M. J., Hofman, L. N., Beltman, J. J., van Driel, W. J., Werner, H. M. J., Baalbergen, A., van Haaften-de Jong, A. M. L. D., Dorman, M., Haans, L., Nedelcu, I., Ewing-Graham, P. C., & van Beekhuizen, H. J. (2022). 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. Annals of Surgical Oncology, 29(8), 4833-4843. https://doi.org/10.1245/s10434-022-11763-2

@article{5748bcc11562452190c1b2f0a6a7c8c7,

title = "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",

abstract = "OBJECTIVE: Standard surgical treatment of advanced-stage ovarian carcinoma with electrosurgery cannot always result in complete cytoreductive surgery (CRS), especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of a neutral argon plasma device can help increase the complete cytoreduction rate.PATIENTS AND METHODS: 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were randomized to either surgery with neutral argon plasma (PlasmaJet) (intervention) or without PlasmaJet (control group). The primary outcome was the percentage of complete CRS. The secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30-day morbidity, and quality of life (QoL).RESULTS: Complete CRS was achieved in 119 patients (75.8%) in the intervention group and 115 patients (67.6%) in the control group (risk difference (RD) 8.2%, 95% confidence interval (CI) -0.021 to 0.181; P = 0.131). In a per-protocol analysis excluding patients with unresectable disease, complete CRS was obtained in 85.6% in the intervention group and 71.5% in the control group (RD 14.1%, 95% CI 0.042 to 0.235; P = 0.005). Patient-reported QoL at 6 months after surgery differed between groups in favor of PlasmaJet surgery (95% CI 0.455-8.350; P = 0.029). Other secondary outcomes did not differ significantly.CONCLUSIONS: Adjuvant use of PlasmaJet during CRS for advanced-stage ovarian cancer resulted in a significantly higher proportion of complete CRS in patients with resectable disease and higher QoL at 6 months after surgery. (Funded by ZonMw, Trial Register NL62035.078.17.) TRIAL REGISTRATION: Approved by the Medical Ethics Review Board of the Erasmus University Medical Center Rotterdam, the Netherlands, NL62035.078.17 on 20-11-2017. Recruitment started on 30-1-2018.",

keywords = "ACHIEVING COMPLETE CYTOREDUCTION, CARCINOMA, ENERGY, IMPACT, NEOADJUVANT CHEMOTHERAPY, NEUTRAL ARGON PLASMA, PRIMARY DEBULKING SURGERY, RESECTION, RESIDUAL DISEASE, TUMOR",

author = "Boer, {G M Nieuwenhuyzen-de} and W Hofhuis and N Reesink-Peters and S Willemsen and Boere, {I A} and Schoots, {I G} and Piek, {J M J} and Hofman, {L N} and Beltman, {J J} and {van Driel}, {W J} and Werner, {H M J} and A Baalbergen and {van Haaften-de Jong}, {A M L D} and M Dorman and L Haans and I Nedelcu and Ewing-Graham, {P C} and {van Beekhuizen}, {H J}",

note = "Funding Information: I.A.B. reports translational research (ctDNA) to the employer (Erasmus MC Cancer Institute) grant by GSK. The study was funded by the Netherlands Organization for Health Research and Development (ZonMw), number 843001805. No relevant conflicts of interest. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = aug,

doi = "10.1245/s10434-022-11763-2",

language = "English",

volume = "29",

pages = "4833--4843",

journal = "Annals of Surgical Oncology",

issn = "1068-9265",

publisher = "Springer, Cham",

number = "8",

}

Boer, GMN, Hofhuis, W, Reesink-Peters, N, Willemsen, S, Boere, IA, Schoots, IG, Piek, JMJ, Hofman, LN, Beltman, JJ, van Driel, WJ, Werner, HMJ, Baalbergen, A, van Haaften-de Jong, AMLD, Dorman, M, Haans, L, Nedelcu, I, Ewing-Graham, PC & van Beekhuizen, HJ 2022, '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', Annals of Surgical Oncology, vol. 29, no. 8, pp. 4833-4843. https://doi.org/10.1245/s10434-022-11763-2

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, G M Nieuwenhuyzen-de; Hofhuis, W; Reesink-Peters, N et al.
In: Annals of Surgical Oncology, Vol. 29, No. 8, 08.2022, p. 4833-4843.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Adjuvant Use of PlasmaJet Device During Cytoreductive Surgery for Advanced-Stage Ovarian Cancer

T2 - Results of the PlaComOv-study, a Randomized Controlled Trial in The Netherlands

AU - Boer, G M Nieuwenhuyzen-de

AU - Hofhuis, W

AU - Reesink-Peters, N

AU - Willemsen, S

AU - Boere, I A

AU - Schoots, I G

AU - Piek, J M J

AU - Hofman, L N

AU - Beltman, J J

AU - van Driel, W J

AU - Werner, H M J

AU - Baalbergen, A

AU - van Haaften-de Jong, A M L D

AU - Dorman, M

AU - Haans, L

AU - Nedelcu, I

AU - Ewing-Graham, P C

AU - van Beekhuizen, H J

N1 - Funding Information: I.A.B. reports translational research (ctDNA) to the employer (Erasmus MC Cancer Institute) grant by GSK. The study was funded by the Netherlands Organization for Health Research and Development (ZonMw), number 843001805. No relevant conflicts of interest. Publisher Copyright: © 2022, The Author(s).

PY - 2022/8

Y1 - 2022/8

N2 - OBJECTIVE: Standard surgical treatment of advanced-stage ovarian carcinoma with electrosurgery cannot always result in complete cytoreductive surgery (CRS), especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of a neutral argon plasma device can help increase the complete cytoreduction rate.PATIENTS AND METHODS: 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were randomized to either surgery with neutral argon plasma (PlasmaJet) (intervention) or without PlasmaJet (control group). The primary outcome was the percentage of complete CRS. The secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30-day morbidity, and quality of life (QoL).RESULTS: Complete CRS was achieved in 119 patients (75.8%) in the intervention group and 115 patients (67.6%) in the control group (risk difference (RD) 8.2%, 95% confidence interval (CI) -0.021 to 0.181; P = 0.131). In a per-protocol analysis excluding patients with unresectable disease, complete CRS was obtained in 85.6% in the intervention group and 71.5% in the control group (RD 14.1%, 95% CI 0.042 to 0.235; P = 0.005). Patient-reported QoL at 6 months after surgery differed between groups in favor of PlasmaJet surgery (95% CI 0.455-8.350; P = 0.029). Other secondary outcomes did not differ significantly.CONCLUSIONS: Adjuvant use of PlasmaJet during CRS for advanced-stage ovarian cancer resulted in a significantly higher proportion of complete CRS in patients with resectable disease and higher QoL at 6 months after surgery. (Funded by ZonMw, Trial Register NL62035.078.17.) TRIAL REGISTRATION: Approved by the Medical Ethics Review Board of the Erasmus University Medical Center Rotterdam, the Netherlands, NL62035.078.17 on 20-11-2017. Recruitment started on 30-1-2018.

AB - OBJECTIVE: Standard surgical treatment of advanced-stage ovarian carcinoma with electrosurgery cannot always result in complete cytoreductive surgery (CRS), especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of a neutral argon plasma device can help increase the complete cytoreduction rate.PATIENTS AND METHODS: 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were randomized to either surgery with neutral argon plasma (PlasmaJet) (intervention) or without PlasmaJet (control group). The primary outcome was the percentage of complete CRS. The secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30-day morbidity, and quality of life (QoL).RESULTS: Complete CRS was achieved in 119 patients (75.8%) in the intervention group and 115 patients (67.6%) in the control group (risk difference (RD) 8.2%, 95% confidence interval (CI) -0.021 to 0.181; P = 0.131). In a per-protocol analysis excluding patients with unresectable disease, complete CRS was obtained in 85.6% in the intervention group and 71.5% in the control group (RD 14.1%, 95% CI 0.042 to 0.235; P = 0.005). Patient-reported QoL at 6 months after surgery differed between groups in favor of PlasmaJet surgery (95% CI 0.455-8.350; P = 0.029). Other secondary outcomes did not differ significantly.CONCLUSIONS: Adjuvant use of PlasmaJet during CRS for advanced-stage ovarian cancer resulted in a significantly higher proportion of complete CRS in patients with resectable disease and higher QoL at 6 months after surgery. (Funded by ZonMw, Trial Register NL62035.078.17.) TRIAL REGISTRATION: Approved by the Medical Ethics Review Board of the Erasmus University Medical Center Rotterdam, the Netherlands, NL62035.078.17 on 20-11-2017. Recruitment started on 30-1-2018.

KW - ACHIEVING COMPLETE CYTOREDUCTION

KW - CARCINOMA

KW - ENERGY

KW - IMPACT

KW - NEOADJUVANT CHEMOTHERAPY

KW - NEUTRAL ARGON PLASMA

KW - PRIMARY DEBULKING SURGERY

KW - RESECTION

KW - RESIDUAL DISEASE

KW - TUMOR

U2 - 10.1245/s10434-022-11763-2

DO - 10.1245/s10434-022-11763-2

M3 - Article

C2 - 35552938

SN - 1068-9265

VL - 29

SP - 4833

EP - 4843

JO - Annals of Surgical Oncology

JF - Annals of Surgical Oncology

IS - 8

ER -