Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for Hepatocellular Carcinoma in Patients With Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 211
- 试验地点
- 6
- 主要终点
- sensitivity for detecting HCC
研究概览
简要总结
The investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in single arm patients.
详细描述
Hepatocellular carcinoma (HCC) is one of the major complications in patients with chronic liver disease. The prognosis of HCC relies on the extent of disease at the time of diagnosis. Hence to detect cancer at an earlier stage, a regular surveillance test is important for the subjects with a high risk of developing cancer. Current guidelines recommend a regular surveillance using ultrasonography (US) at a 6 month-interval. Ultrasonography is a non-invasive and safe procedure, yet it is limited by the skills of the operator and it is often difficult to differentiate cancer from regenerating nodules especially in atrophied cirrhotic liver. According to a recent meta-analysis, the overall sensitivity and specificity of detecting liver cancer using ultrasonography were both over 90%, however the sensitivity was decreased to 60% in detecting early lesions in which surgery or liver transplantation is indicated. Of note, addition of alpha feto protein(AFP) to ultrasonography also failed to increase the sensitivity in detecting small cancers. Taken together, there is a need to develop a new surveillance test with an improved sensitivity and specificity.
Recently, a retrospective study reported that CT or MRI showed a better sensitivity than ultrasonography in detecting early liver cancer. However, performing CT as a surveillance test is limited by frequent exposure to radiation and contrast-dye agent. Although MRI does not have the risk of radiation-exposure, it is limited by the high cost and limited availability. On the contrast, non-contrast MRI offers a cost that is comparable to US and an absence of exposure to radiation or contrast-dye agent, which suggests non-contrast MRI as a good alternative surveillance tool for early detection of HCC. Therefore, in this prospective trial, the investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject older than 40 years of age at the enrollment
- •Fulfill below conditions A and B
- •A. The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
- •Histologically by liver biopsy;
- •Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
- •Evidence of portal hypertension, including any of followings;
- •The identification of splenomegaly on ultrasonography, CT, or MRI examinations with typical features of cirrhosis
- •The identification of esophageal or gastric varices on endoscopic examination
- •B. Risk Index larger than 2.33; Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100,000/mm3) + 0.74 (if the presence of HCV is positive).
排除标准
- •Presence of liver cancer or other intrahepatic malignancy
- •Has a history of malignancy within previous 5 years
- •Is pregnant or breast-feeding
结局指标
主要结局
sensitivity for detecting HCC
时间窗: 3 years
sensitivity for detecting HCC
次要结局
- false referral rate for HCC(3 years)
- survival of the patients who developed HCC on follow-up period(years)
研究者
JOON-IL CHOI
Associate professor
Seoul St. Mary's Hospital