Intraperitoneal chemotherapy hyperthermia (HIPEC) for peritoneal carcinomatosis of ovarian cancer origin by fluid and CO₂ recirculation using the closed abdomen technique (PRS-1.0 Combat): A clinical pilot study

Figures & data

Table 1. Surgical procedures.

	Patients
Surgical procedures	N	%
Pelvic lymphadenectomy	18	85.7
Aortic lymphadenectomy	18	85.7
Greater omentectomy	17	81.0
Hysterectomy	13	61.9
Bilateral oophorectomy	12	57.1
Apendicectomy	11	52.4
Small bowel resection	2	9.5
Large bowel resection	6	28.6
Right/left upper quadrant peritonectomy	7	33.3
Splenectomy	3	14.28
Gastrectomy	1	4.76
Liver resection	1	4.76
Bowel anastomosis	5

Table 2. Blood data collected during the procedure.

	Basal	Pre-HIPEC	p*	Post-HIPEC	p**
Haemoglobin (mg/dL)	12.014 ± 0.363	9.257 ± 0.423	<0.001	9.848 ± 0.380	0.356
Haematocrit (%)	35.79 ± 1.009	28.69 ± 1.327	<0.001	30.043 ± 1.128	0.492
Prothrombin activity (%)	94.85 ± 2.017	75.695 ± 3.376	<0.001	74.30 ± 2.874	0.605
pH	7.413 ± 0.007	7.333 ± 0.13	<0.001	7.299 ± 0.15	0.107
HCO3 (mmol/L)	23.671 ± 0.432	20.633 ± 0.599	<0.001	18.100 ± 0.555	<0.001
pCO2 (mmHg)	36.810 ± 0.709	37.619 ± 0.866	0.424	39.571 ± 1.273	0.202
Lactic acid (mg/dL)	11.952 ± 1.328	16.714 ± 2.298	0.022	32 ± 3.345	<0.001

Basal, basal line (before surgery); Pre-HIPEC, at the end of cytoreductive surgery, and before HIPEC administration; Post-HIPEC, at the end of HIPEC administration.

Mean and standard variations are shown.

*p-value between basal and pre-HIPEC data.

**p-value between pre-HIPEC and post-HIPEC data.

Table 3. Haemodynamic data collected during the procedure.

	Pre-HIPEC	Intra-HIPEC	p*	Post-HIPEC	p**
SVV, %	14.137 ± 1.191	14.842 ± 0.794	0.603	14.368 ± 1.05	0.698
GEVI, mL/m^2	646.737 ± 31.745	643.158 ± 25.21	0.787	653.263 ± 25.25	0.714
CPI, L.min^−2	4.13 ± 0.033	4.26 ± 0.035	0.653	5.50 ± 0.04	0.013
Cardiac index, L.min^−1.m ^−2	3.4 ± 0.7	2.8 ± 0.5	0.03	3.2 ± 0.8	0.21
ELWI, mL/kg	9.126 ± 0.509	8.505 ± 0.382	0.078	9.874 ± 0.809	0.101
ITBI, mL/m^2	1207.9 ± 73.823	1157.8 ± 38.278	0.412	1556.9 ± 69.027	0.985
SVRI, dyn/cm^−5/m^2	2098.471 ± 225.013	1909.94 ± 139.79	0.430	1572.765 ± 116.251	0.02
Heart rate, bpm	74.4 ± 4.28	81.1 ± 4.89	0.079	86.6 ± 4.78	0.412
Blood temperature, °C	34.863 ± 0.227	37.437 ± 0.259	<0.001	36.332 ± 0.34	0.011
Oesophageal temperature, °C	34.6 ± 1.1	37.4 ± 0.5	0.001	35.9 ± 1.1	0.001

SVV, stroke volume variation; GEVI, global end-diastolic volume index; CPI, cardiac performance index; ELWI, extravascular lung water index; ITBI, intrathoracic total blood index; SVRI, systemic vascular resistances index; Pre-HIPEC, at the end of cytoreductive surgery, and before HIPEC administration; Intra-HIPEC, at 30 min of HIPEC administration; Post-HIPEC, at the end of HIPEC administration.

Mean and standard variations are shown.

*p-value between basal and intra-HIPEC data.

**p-value between intra-HIPEC and post-HIPEC data.

Table 4. Serie morbidity.

	Grade (NCI-CTCAE 4.0)
Systems	I	II	III	IV	Total
Haematological					5
Anaemia	1	2
Leucopenia			1
Intra-abdominal bleeding			1
Infection					6
Wound infection	1		3
Intra-abdominal infection			1
Pneumonia			1
Gastrointestinal					3
Ileus			1
Nausea/vomiting		2
Genito-urinary					4
Acute renal failure	2
Urinary bleeding	1
Acute renal infection			1
Pulmonary					4
Upper respiratory infection		1
Pleural effusion	1
Endothoracic drain			1
Respiratory distress				1
Total	6	5	10	1	22

Figure 1. Schema device of PRS-1.0 Combat^® system for closed abdomen HIPEC showing the flow direction during the procedure. A and B, roller pumps; D, gas exchanger to CO₂ recirculation and visual control of filling abdominal cavity; blue keg, abdominal cavity; green line, solution and drug inflow and outflow tubes; yellow line, CO₂ recirculation tube; black line, CO₂ inflow tube.

Figure 2. PRS-1.0 Combat^® system for closed abdomen HIPEC administration.

Table 5. Frequency of perioperative morbidity.

				Morbidity (%)a
Reference (patients)	H (hours)	HS (days)	Mortality (%)	I	II	III	IV
Pavlov et al. 2009 (N = 25) [35]	5	14	2	5	11	0	2
Fagotti et al. 2009 (N = 25) [36]	5	13	0	0	36	8	8
Bae et al. 2007 (N = 67) [12]	–	–	0	14	13	0	0
Cotte et al. 2007 (N = 81) [19]	4	17	3	6	1	5	2
Helm et al. 2007 (N = 18) [37]	10	12	6	11	50	40	13
Rufián et al. 2006 (N = 33) [14]	5	11	0	12	10	10	6
Sánchez-García et al. 2014 (N = 21) actual series	7	13	4.76	27	22	45	4

H, surgical hours; HS, hospital stay.

a Common Terminology Criteria for Adverse Events (CTCAE) classification.

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