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Page 4 of 16 Chen et al. Hepatoma Res 2018;4:72 I http://dx.doi.org/10.20517/2394-5079.2018.103

Table 1. Randomised controlled trials on hepatocellular carcinoma surveillance
Sample Surveil- Stage at
Author, year Study size Continent lance Etiology (%) diagnosis Mortality Survival Treatment
period (S vs. modality (%) (%) (%)
NS)
a,
[12]
Chen et al. , 1989-1995 3712 vs. Asia AFP HBV # I *: 29.6 vs. 6 HCC mortality 1-year: NA
2003 1869 (China) 6-mthly Cirrhosis: NA II: 50.6 vs. 53 per 100,000: 23.7 vs.
vs. none III: 19.8 vs. 41 1,138 vs. 1,114 9.7
(P = 0.86) 3-year: 7
vs. 4
5-year: 4
vs. 4.1
a
Zhang et al. [11] , 1993-1995 9373 vs. Asia US + AFP HBV I : 60.5 vs. 0 HCC mortality 1-year: Resection:
2004 9443 (China) vs. none Cirrhosis: NA II: 13.9 vs. per 100,000: 65.9 vs. 46.5 vs. 7.5
37.3 83.2 vs. 131.5 31.2 TACE or PEI:
III: 25.6 vs. RR 0.63 (95% 3-year: 32.6 vs. 41.8
62.7 CI: 0.41 to 52.6 vs. Conservative
(P < 0.010) 0.98); 7.2 treatment:
(P < 0.010) 5-year: 20.9 vs. 50.7
46.4 vs. 0
[13]
Trinchet et al. , 2000-2006 640 (3 Europe US 3 Histo-proven cir- Within Milan Overall mortal- 2-year: LTx: 18.9 vs. 4.3
2011 months) (France, monthly rhosis: all criteria : b ity (%): 95.8 vs. Resection: 5.7
vs. 638 (6 Belgium) vs. Alcohol: 39.4 vs. 79.2 vs. 71.4 11.3 vs. 12.1 93.5 vs. 9.7
months) 6-monthly 39 (P = 0.4) (P = 0.38) 5-year: Ablation: 37.7
HCV: 44.7 vs. 43.6 84.9 vs. vs. 44.3
HBV: 12.8 vs. 12.2 85.8 Supportive
Hemochromatosis: care 9.4 vs. 17.1
0.8 vs. 2.3 (P = 0.1)
Others: 2.3 vs. 2.6
c
Wang et al. [14] , 2006-2010 387 (4 Asia US HepB: 30 vs. 25.2 BCLC stage : NA 1-year: Curative Rx:
2013 months) (Taiwan, 4-monthly HepC: 63 vs. 67.2 0: 37.5 vs. 6.7 95.8 vs. 13 vs. 3
vs. 357 China) vs. Cirrhosis: 87.5 vs. A: 54.2 vs. 80 Others: 45.8
(12 12-month- 100 66.6 2-year: vs. 80
months) ly (P = 0.27) Others: 8.3 78.8 vs. (P = 0.049)
vs. 26.7 64
(P = 0.017) 5-year:
57.4 vs. 56
(P =
0.399)
Taylor et al. [16] , Markov 1000 vs. NA 6-monthly Cirrhosis: all (simu- NA HCC mortality NA NA
2017 model 1000 US vs. lated) 69 vs. 82 (NNS
none 77)
Harm (addi-
tional imag-
ing/biopsy)
150 (NNH 7)
# HBV: patients with positive serum Hepatitis B surface antigen; *including cases diagnosed with HCC within the first two months of
a
enrolment; clinical classification of the China Liver Cancer Study group; stage I (early stage, subclinical disease) included patients with
no symptoms (and a tumour usually < 5 cm in diameter) at first diagnosis. Stage III (advanced stage), included patients with severe liver
b
dysfunction. The remaining cases between stage I and III were classed as stage II (middle stage); Milan criteria: one tumor ≤ 50 mm in
c
diameter, or 2-3 tumors ≤ 30 mm in diameter without vascular extension or metastasis (based on computed tomography scan); BCLC
staging - stage 0: tumor < 2 cm, performance status (PS) 0 and the Child-Pugh A; stage A: single tumor < 5 cm, or up to 3 tumors all
< 3 cm, PS 0 and Child-Pugh A or B; stage B: multinodular HCC, PS 0 and Child-Pugh A or B; stage C: portal, lymph node or organ
invasion, or PS 1 or 2, Child-Pugh A or B; stage D: PS > 2 or Child-Pugh C. AFP: alpha-fetoprotein; BCLC: Barcelona Clinic Liver Cancer
staging; HBV: hepatitis B virus; HCC: hepatocellular carcinoma; HCV: hepatitic C virus; TACE: transarterial chemoembolization; PEI:
percutaneous ethanol injection; NA: not available; NNH: number needed to harm; NNS: number needed to screen; LTx: liver transplant;
OR: odds ratio; S: surveillance group; NS: no surveillance group; Tx: treatment; US: ultrasound

small focal lesions, however no survival difference was observed between the 2 randomized groups. A com-
munity-based study in Taiwan compared 4-monthly to 12-monthly ultrasound surveillance for viral hepati-
tis B/C patients with platelet level more than 150,000/mL. More frequent surveillance detected smaller HCCs
that were amenable for curative treatment modalities. However there was no significant difference in overall
[14]
survival [Table 1].

[15]
Poustchi et al. attempted to conduct a RCT on HCC surveillance for cirrhotic patients. After risk and
benefits of surveillance were discussed, 99.5% of the patients declined randomization, demonstrating the dif-