Compensated Liver Cirrhosis Clinical Trial
Official title:
Usefulness of Non-contrast MagnetIc Resonance imAging Versus Non-Contrast Ultrasonography for surveiLlancE of HepatoCellular Carcinoma [MIRACLE-HCC]
The investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma through this prospective, randomized trial.
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 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 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. 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, randomized
trial, the investigators will investigate the usefulness of ultrasonography versus
non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03778775 -
Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)
|