A novel internal cold circulation radiofrequency-assisted device for liver transection

Figures & data

Figure 1. Flow chart of the study.

Table 1. Baseline characteristics of enrolled patients.

Variables	New-RF group (n = 45)	Habib-4X group (n = 40)	p-Value
Gender			0.797^a
Male	26 (57.8%)	22 (55.0%)
Female	19 (42.2%)	18 (45.0%)
Age (years old)			0.165^c
Mean ± SD	52.04 ± 3.26	51.11 ± 2.80
Median, (Range)	54 (28–75)	53 (31–72)
Liver function			0.909^a
Child-Pugh grade A	39 (86.7%)	35 (87.5%)
Child-Pugh grade B	6 (13.3%)	5 (12.5%)
ICGR-15 (%)			0.920^c
Mean ± SD	6.45 ± 2.83	6.51 ± 2.60
Median, (Range)	6.2 (2–19.5)	6.5 (0.2–16.5)
Albumin (g/l)			0.528^c
Mean ± SD	43.06 ± 5.22	42.32 ± 5.54
Median, (Range)	43.5 (37.7–44.6)	41.6 (33.6–47.6)
TBIL (umol/l)			0.149^b
Mean ± SD	13.11 ± 4.76	17.95 ± 8.75
Median, (Range)	11.5 (8.2–22.3)	16.6 (8.5–36.9)
PT (s)			0.084^b
Mean ± SD	11.78 ± 0.82	12.85 ± 1.50
Median, (Range)	12.0 (10.5–12.6)	13.1 (10.7–15.9)
ALT (IU/l)			0.168^b
Mean ± SD	27.50 ± 18.20	41.36 ± 38.20
Median, (Range)	23 (9–75)	28 (3–147)
AST (IU/l)			0.180 ^b
Mean ± SD	36.40 ± 21.61	44.09 ± 19.53
Median, (Range)	28.5 (17–72)	40 (26–77)
AFP (μg/l)			0.832^b
Mean ± SD	276.60 ± 495.55	412.44 ± 537.52
Median, (Range)	34.35 (2.24–1210)	59.55 (1.61–1520)
Etiology			0.882^a
HBV	31 (68.9%)	27 (67.5%)
HCV	3 (6.7%)	4 (10.0%)
Others	11 (24.4%)	9 (22.5%)
Liver cirrhosis			0.791^a
With	17 (37.8%)	14 (35.0%)
Without	28 (62.2%)	26 (65.0%)
Tumor number			0.594^a
Single	40 (89.9%)	34 (11.1%)
Multiple	5 (85.0%)	6 (15.0%)
Tumor diameter (cm)			0.306^c
Mean ± SD	6.22 ± 1.60	5.88 ± 1.42
Median, (Range)	6.9 (2.3–9.6)	6.7 (2.7–8.9)

Note. ^athe proportion of the groups is compared using χ² test; ^bdata obeying skewed distribution. Wilcoxon rank sum test is used for comparison between groups; ^cdata obeying normal distribution with consistent population variance. Student’s t-test is used for comparison between groups.

Skewness data is represented by median and range within parentheses.

ICGR-15: 15-min indocyanine green retention rate; TBIL: total bilirubin; ALT: alanine aminotransferase; AST: aspartate aminotransferase; PT: prothrombin time; AFP: alpha-fetoprotein; HBV: hepatitis B virus; HCV: hepatitis C virus.

Figure 2. The electrode was inserted along the marked line to coagulate the liver tissue.

Figure 3. Vascular forceps or tissue scissors were used to excise the liver along the ‘no blood circulation’ tissue plane.

Figure 4. The process obeyed the sequence of ‘coagulation to excision’, which allowed us to change the direction during the liver excision according to the position, size and shape of the tumor.

Table 2. Intraoperative data of enrolled patients.

Variables	New-RF group (n = 45)	Habib-4X group (n = 40)	p-Value
Liver resection			0.861^a
Minor liver resection (<3 segments)	33 (77.3%)	30 (75.0%)
Wedge resection	20 (44.4%)	21 (52.5%)	0.458^a
Segment resection	13 (28.9%)	9 (22.5%)	0.502^a
Major liver resection (≥3 segments)	12 (26.7%)	10 (25.0%)
Hemihepatectomy	6 (13.3%)	4 (10.0%)	0.890^a
3 liver segments resection	4 (8.9%)	5 (12.5%)	0.852^a
Extended hemihepatectomy	2 (4.4%)	1 (2.5%)	1.000^a
Pringle operation			1.000^a
Yes	3 (6.7%)	4 (10.0%)
No	42 (93.3%)	36 (90.0%)
Total hemorrhage (ml)			0.698^b
Mean ± SD	319.09 ± 422.44	362.50 ± 436.75
Median, (Range)	165 (50–1550)	187.5 (55–1525)
Hemorrhage during transection (ml)			0.438^b
Mean ± SD	124.09 ± 205.55	152.00 ± 248.30
Median, (Range)	85 (10–735)	105 (10–850)
Average hemorrhage per square centimeter (ml/cm^2)			0.141^c
Mean ± SD	3.28 ± 0.86	3.60 ± 1.12
Median, (Range)	2.8 (1.8–5.6)	3.2 (2.1–6.0)
Blood transfusion			0.843^a
Yes	5 (11.1%)	5 (12.5%)
No	40 (88.9%)	35 (87.5%)
RBCs transfused (units)			0.783^b
Mean ± SD	0.44 ± 1.27	0.60 ± 1.65
Median, (Range)	0 (0–4)	0 (0–6)
Total operation time (min)			0.323^b
Mean ± SD	157.72 ± 53.64	178.00 ± 61.92
Median, (Range)	145 (60–275)	170 (75–295)
Operation time of transection (min)			0.010^c
Mean ± SD	55.04 ± 16.12	64.02 ± 15.09
Median, (Range)	54 (22–84)	52 (25–92)
Device usage time (min)			0.778^b
Mean ± SD	17.09 ± 11.67	17.60 ± 12.29
Median, (Range)	11 (5–40)	16 (5–50)
Average transection speed (cm^2/min)			<0.001^c
Mean ± SD	4.81 ± 1.20	3.64 ± 1.08
Median, (Range)	4.4 (3.0–5.8)	3.8 (2.8–5.2)
Width of coagulation tissue (cm)			<0.001^c
Mean ± SD	1.42 ± 0.23	1.81 ± 0.20
Median, (Range)	1.2 (0.8–1.8)	1.6 (1.4–2.2)
Needle path bleeding			0.019^a
Yes	6 (13.3%)	14 (35.0%)
No	39 (86.7%)	26 (65.0%)
Carbonization of electrode needle			<0.001^a
Yes	10 (22.2%)	25 (62.5%)
No	35 (77.8%)	15 (37.5%)

Note. ^athe proportion of the groups is compared using χ² test; ^bdata obeying skewed distribution. Wilcoxon rank sum test is used for comparison between groups; ^cdata obeying normal distribution with consistent population variance. Student’s t-test is used for comparison between groups.

Skewness data is represented by median and range within parentheses.

Table 3. Lab examinations of patients after surgery.

Variables	New-RF group (n = 45)	Habib-4X group (n = 40)	p-Value
TBIL (umol/l)
1 day after surgery	14.3 (8.2–30.4)	17.4 (5.2–55.3)	0.378^b
3 days after surgery	20.7 (9.3–33.3)	28.9 (9.4–49.6)	0.260^b
7 days after surgery	15.8 (11.0–30.8)	15.4 (4.7–40.5)	0.944^b
PT(s)
1 day after surgery	14.5 (13.0–20.1)	15.4 (12.2–21.3)	0.573^b
3 days after surgery	13.4 (11.9–16.7)	14.9 (11.6–18.7)	0.324^b
7 days after surgery	12.6 (11.4–13.4)	13.6 (12.3–15.6)	0.056^b
ALT(IU/l)
1 day after surgery	251 (125–1010)	364 (5–983)	0.360^b
3 days after surgery	104 (59–252)	130 (2–382)	0.778^b
7 days after surgery	64 (27–141)	50 (5–100)	0.888^b
AST(IU/l)
1 day after surgery	276.5 (127–535)	359 (161–497)	0.360^b
3 days after surgery	42.5 (24–95)	51 (20–143)	0.698^b
7 days after surgery	34.5 (13–51)	30 (18–47)	0.944^b

Note. ^bdata obeying skewed distribution. Wilcoxon rank sum test is used for comparison between groups. Skewness data is represented by median and range within parentheses.

TBIL: total bilirubin; PT: prothrombin time; ALT: alanine aminotransferase; AST: aspartate aminotransferase.

Table 4. Complications of patients after surgery.

Variables	New-RF group (n = 45)	Habib-4X group (n = 40)	p-Value
Complications	5 (11.1%)	8 (20.0%)	0.256^a
Biliary fistula	1 (2.2%)	2 (5.0%)	0.917^a
Abdominal infection	1 (2.2%)	3 (7.5%)	0.526^a
Pleural effusion	3 (6.7%)	2 (5.0%)	1.000^a
Liver failure	0	1 (2.5%)	0.953^a
ICU time (days)			0.604^b
Mean ± SD	0.16 ± 0.56	0.18 ± 0.50
Median, (Range)	0 (0–3)	0.5 (0–2)
Total hospitalization time (days)			0.178^c
Mean ± SD	14.61 ± 2.52	15.40 ± 2.84
Median, (Range)	16 (10–18)	17 (11–20)
30-day mortality	0	1 (2.5%)	0.953^a

Note. ^athe proportion of the groups is compared using χ² test; ^bdata obeying skewed distribution. Wilcoxon rank sum test is used for comparison between groups; ^cdata obeying normal distribution with consistent population variance. Student’s t-test is used for comparison between groups.

Skewness data is represented by median and range within parentheses.