Clinical Trials Study
Copyright ©The Author(s) 2023.
World J Gastroenterol. Feb 7, 2023; 29(5): 890-903
Published online Feb 7, 2023. doi: 10.3748/wjg.v29.i5.890
Table 1 Baseline characteristics of patients with intermediate-stage hepatocellular carcinoma

N-acetylcysteine + dexamethasone
Placebo
P value
Sex
    Male44 (88%)45 (90%)0.75
Age (mean ± SD)60.8 ± 10.5260.46 ± 11.270.88
Underlying disease
    Diabetic mellitus17 (34%)16 (32%)0.83
    Hypertension22 (14%)28 (56%)0.23
    Dyslipidemia14 (28%)18 (36%)0.40
    CKD1 (2%)2 (4%)0.56
    HIV1 (2%)1 (2%)1.00
Tumor characteristic
Size
    Median (range)5.5 (1.4-19)7.95 (1.4-17.2)0.39
    > 3 cm40 (80%)42 (84%)0.65
Number
    Median (range)2 (1-10)2 (1-10)0.21
    123 (46%)17 (34%)0.56
    ≥ 227 (54%)33(66%)
Etiology
    Hepatitis B23 (46%)28 (56%)0.31
    Hepatitis C15 (30%)12 (24%)0.50
    Alcoholic22 (44%)20 (40%)0.67
    Non-alcoholic steatohepatitis3 (6%)4 (8%)0.70
Staging
    BCLC-A6 (12%)3 (6%)0.23
    BCLC-B44 (88%)47 (94%)
Child-Pugh Score
    A (5-6)40 (80%)43 (86%)0.42
    B (7-8)10 (20%)7 (14%)
ALBI score (mean ± SD)-2.61 ± 0.58-2.54 ± 0.530.54
Alpha fetoprotein (ng/mL)
    < 2018 (36%)19 (38%)0.50
    20-20014 (28%)9 (18%)
    201-100010 (20%)9 (18%)
    > 10008 (16%)13 (26%)
Episode of TACE
    116 (32%)18 (36%)0.67
    2-534 (68%)32 (64%)
Embolization agents
    Mitomycin (mg)
    5-101 (2%)3 (6%)0.07
    10.1-1520 (40%)10 (20%)
    15.1-2029 (58%)37 (74%)
    Lipiodol (mL)
    < 51 (2%)1 (2%)0.47
    5-1013 (26%)8 (16%)
    > 1036 (72%)41 (82%)
Level of embolization
    Left hepatic artery17 (34%)14 (28%)0.51
    Right hepatic artery46 (92%)44 (88%)0.50
    Middle hepatic artery5 (10%)3 (6%)0.46
    ≥ 2 major branches18 (36%)8 (16%)0.02
Table 2 Comparison between patients based on the occurrence of post-embolization syndrome and liver decompensation after conventional transarterial chemoembolization

PES after cTACE
P value
Liver decompensation after TACE
P value
Yes (n = 43)
No (n = 57)
Yes (n = 7)
No (n = 93)
Male40 (93%)49 (86%)0.267 (100%)82 (88.2%)0.34
Age (mean ± SD)60.72 ± 11.1160.56 ± 10.740.2663.57 ± 7.9160.41 ± 11.040.35
Child-Pugh score5.35 ± 0.695.61 ± 0.90.095.86 ± 0.95.47 ± 0.820.24
    A (5-6)40 (93%)43 (75.4%)0.025 (71.4%)78 (83.9%)0.4
    B (7-8)3 (7%)14 (24.6%)0.022 (28.6%)15 (16.1%)0.4
ALBI (median; IQR)-2.72 (-3.05, -2.29)-2.65 (-2.93, -2.2)0.47-1.95 (-2.74, -1.77)-2.69 (-3.04, -2.29)0.09
MELD (mean ± SD)11.67 ± 3.5412.05 ± 3.780.6112.71 ± 3.8611.83 ± 3.660.54
Staging
    BCLC-A3 (7%)6 (10.5%)0.541 (14.3%)8 (8.6%)0.61
    BCLC-B40 (93%)51 (89.5%)0.546 (85.7%)85 (91.4%)0.61
Tumor characteristics
AFP ≥ 200 ng/mL17 (39.5%)27 (47.4%)0.443 (42.9%)28 (30.1%)0.48
Median (range)9.6 (4,13.2)5 (3.2,10)0.055.7 (3.2,15)7 (3.2,13)0.8
Large tumor ≥ 5 cm29 (67.4%)27 (47.4%)0.0454 (57.1%)52 (55.9%)0.95
Number
    118 (41.9%)22 (38.6%)0.744 (57.1%)36 (38.7%)0.34
    ≥ 225 (58.1%)35 (61.4%)3 (42.9%)57 (61.3%)
Size plus number
    Up to 732 (74.4%)37 (64.9%)0.314 (57.1%)65 (69.9%)0.48
    Up to 1221 (48.8%)15 (26.3%)0.023 (42.9%)33 (35.5%)0.7
cTACE episode
    115 (34.9%)19 (33.3%)0.874 (57.1%)30 (32.3%)0.18
    ≥ 2 (2-5)28 (65.1%)38 (66.7%)3 (42.9%)63 (67.7%)
Embolization agent
Mitomycin (mg)
    < 102 (4.7%)2 (3.5%)0.440 (0%)4 (4.3%)0.51
    10-1510 (23.3%)20 (35.1%)1 (14.3%)29 (31.2%)
    15.1-2031 (72.1%)35 (61.4%)6 (85.7%)60 (64.5%)
Lipiodol (mL)
    < 51 (2.3%)1 (1.8%)0.320 (0%)2 (2.2%)0.82
    5-106 (14%)15 (26.3%)1 (14.3%)20 (21.5%)
    > 1036 (83.7%)41 (71.9%)6 (85.7%)71 (76.3%)
Level of embolization
    Left hepatic artery10 (23.3%)18 (31.6%)0.363 (42.9%)28 (30.1%)0.32
    Right hepatic artery38 (88.4%)44 (77.2%)0.157 (100%)83 (89.2%)0.37
    Middle hepatic artery1 (2.3%)7 (12.3%)0.070 (0%)8 (8.6%)0.43
    1 vessel37 (86%)34 (59.6%)0.0043 (42.9%)67 (72%)0.25
    ≥ 2 vessels6 (14%)23 (40.4%)0.0074 (57.1%)26(28%)0.02
Baseline laboratory (median; IQR)
    Hct (%)36.8 (32.3, 40.3)35 (32.6, 38.9)0.3339.8 (36.6, 40.6)35.2 (32.2, 39)0.04
    WBC (× 109/L)5.83 (4.50, 7.18)5.48 (4.13, 6.97)0.185.49 (4.14, 6.08)5.58 (4.29, 7.07)0.57
    Platelet (× 109/L)186 (125, 241)144 (103, 204)0.09105 (65, 226)171 (117, 230)0.39
    PTT (s)12.9 (12.3, 13.8)13.5 (12.7, 14.7)0.0213 (12.1, 13.2)13.1 (12.4, 14.2)0.34
    AST (U/L)51 (35, 102)47 (37, 79)0.78163 (102, 169)49 (36, 77)0.003
    ALT (U/L)35 (20, 80)33 (21, 51)0.29106 (80, 139)31 (20, 51)< 0.001
    ALP (U/L)124 (104, 290)120 (93, 153)0.211290 (121, 386)120 (94, 169)0.111
    Albumin (g/dL)4 (3.6, 4.2)3.9 (3.5, 4.2)0.5693.7 (3.2, 4.1)3.9 (3.6, 4.2)0.360
    Total bilirubin (mg/dL)0.59 (0.39, 1)0.69 (0.51, 1.3)0.1631.59 (0.82, 2.11)0.59 (0.42, 1.01)0.005
    Direct bilirubin (mg/dL)0.35 (0.24, 0.65)0.39 (0.26, 0.78)0.4150.91 (0.49, 1.76)0.35 (0.24, 0.65)0.004
Presence of PES, n (%)---7 (100%)36 (38.7%)0.002
    Fever40 (93.0%)5 (8.8%)< 0.0017 (100%)38 (40.9%)0.002
    Vomit25 (58.1%)2 (3.5%)< 0.0013 (42.9%)24 (25.8%)0.327
    Pain5 (11.6%)0 (0.0%)0.0080 (0.0%)5 (5.37%)0.529
    Anorexia21 (48.8%)2 (3.5%)< 0.0014 (57.1%)17 (18.3%)0.015
Table 3 Univariate and multivariate analyses of patients with post-embolization syndrome and liver decompensation after conventional transarterial chemoembolization
ParameterPES after cTACE
Liver decompensation after cTACE
Crude OR
95%CI
P value
aOR
95%CI
P value
Crude OR
95%CI
P value
aOR
95%CI
P value
NAC + DEXA0.020-0.06< 0.010.040.01-0.2< 0.0100-11.0000-11.00
Size + number up to 121.091-1.190.041.080.92-1.270.330.990.84-1.160.88---
AST rise > 20 folds in 48 h1.511.09-2.090.011.350.72-2.520.351.70.95-3.030.071.30.56-3.020.54
ALBI change > 0.57.581.96-29.360.0033.030.39-23.670.29122.525.6-26810.00242.771.01-18100.049
Total bilirubin rising > 1.5 folds3.831.8-8.14< 0.011.430.42-4.870.572.791.23-6.310.011.460.52-4.10.48
South west oncology grading > 410-10.99 - - -1.431.04-1.960.030.940.51-1.760.86