Abstract
This study aimed to compare ultrasonography (US) and non-contrast magnetic resonance imaging (MRI) in the surveillance of hepatic malignancy. We conducted a randomized, non-blinded, single-center trial at a single center in South Korea. Eligible individuals were aged 20-70 years with liver cirrhosis, Child-Pugh class A, and no history of liver cancer or other recent malignancy. Participants were randomized 1:1 to receive up to ten semiannual surveillance using US or non-contrast MRI with serum alpha-fetoprotein testing. The primary endpoints were the detection rates of Barcelona Clinic Liver Cancer [BCLC] stage 0 or A tumors, stage distribution at initial diagnosis, and false-positive referral rates. From June 2015 to November 2017, 416 patients were screened, and 414 were enrolled and assigned to the US (n=207) or MRI (n=207) group. In total, 23 participants in US group and 25 in MRI group were diagnosed with liver cancer by November 2022. The detection rates of BCLC stage 0 or A tumors were not different between the US and MRI groups (8% [95% confidence interval (CI), 5 - 13%] versus 12% [8 - 17%]). BCLC stage 0 tumors were more prevalent in the MRI group than in the US group (8% versus 3%). The MRI group had earlier BCLC stage (P=0.014) and lower false-positive referral rate (0.7% [95% CI, 0.4 - 1.2%] versus 3.1% [2.3 - 4.1%], P <0.001) compared to the US group. Non-contrast MRI is a better alternative to US for the surveillance of cirrhotic patients offering earlier stage at initial diagnosis and lower false-positive referral rate. ClincalTrials.gov, NCT02514434.
Published Version
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