Noncontrast Magnetic Resonance Imaging vs Ultrasonography for Hepatocellular Carcinoma Surveillance: A Randomized, Single-Center Trial.

Methods

We conducted a randomized, nonblinded trial at a single center in South Korea.

我们在韩国的一个中心进行了这项随机、非盲的试验。

Eligible individuals were aged 20 to 70 years with liver cirrhosis, Child-Pugh class A, and no history of liver cancer or other recent malignancy.

符合条件的个体年龄在20至70岁之间，患有肝硬化，Child-Pugh A级，且无肝癌或其他近期恶性肿瘤病史。

Participants were randomized 1:1 to receive up to 10 semiannual surveillance using US or noncontrast MRI with serum alpha-fetoprotein testing.

参与者按1:1的比例随机接受最多10次半年一次的使用超声或非对比增强MRI以及血清甲胎蛋白检测的监测。

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.

主要终点是检测到的巴塞罗那临床肝癌（BCLC）0期或A期肿瘤的检出率、初始诊断时的分期分布以及假阳性转诊率。

Results

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.

从2015年6月到2017年11月，共筛查了416名患者，414名被纳入研究并分配到超声（n = 207）组或MRI（n = 207）组。

In total, 23 participants in the US group and 25 in the MRI group were diagnosed with liver cancer by November 2022.

截至2022年11月，美国组共有23名参与者和MRI组共有25名参与者被诊断出肝癌。

The detection rates of BCLC stage 0 or A tumors were not different between the US and MRI groups (7% [95% confidence interval(CI), 4%-11%] vs 12% [8%-17%]).

BCLC 0期或A期肿瘤的检出率在超声组和MRI组之间没有差异（7% [95%置信区间（CI），4%-11%] 对比 12% [8%-17%]）。

BCLC stage 0 tumors were more frequently detected in the MRI group than in the US group (8% vs 2%).

BCLC 0期肿瘤在MRI组中的检出频率高于超声组（8%对比2%）

The MRI group had earlier BCLC stage (P = .014) and lower false-positive referral rate (0.7% [95% CI, 0.4%-1.2%] vs 3.1% [2.3%-4.1%], P < .001) compared with the US group.

MRI组的BCLC分期更早（P = .014），假阳性转诊率更低（0.7% [95% 置信区间, 0.4%-1.2%] 对比 3.1% [2.3%-4.1%], P < .001），相较于超声组。

Conclusions

Noncontrast 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.

非对比增强MRI是监测肝硬化患者的更好选择，因为它在初次诊断时能提供更早期的分期，并且假阳性转诊率较低。

(ClincalTrials.gov, Number: NCT02514434.).

（ClincalTrials.gov，编号：NCT02514434）。