Iron Overload Clinical Trial
Official title:
Influence of Iron Depletion by Phlebotomy on the Risk of Hepatocellular Carcinoma Occurrence in Patients With Compensated Alcoholic Cirrhosis. Prospective, Multicentre, Randomized Trial
The main objective of the study is to assess in patients with compensated alcoholic cirrhosis and hepatic iron overload (HIO), as assessed by MRI, the effect of phlebotomy in order to lower and maintain serum ferritin below 50 µg / l on the risk of hepatocellular carcinoma (HCC) occurrence. The effect of bloodletting will be jointly evaluated on 1) episodes of hepatic decompensation, 2) non HCC liver-related mortality 3) changes in HIO during follow-up.
Purpose
The role of iron in liver carcinogenesis is supported by human, animal and cellular models
through direct and indirect mechanisms. The accumulation of iron promotes liver cell
proliferation and is responsible for direct structural damage or mutations of DNA caused by
free iron itself or reactive oxygen species generated by its accumulation in the liver.
The influence of hepatic iron overload (HIO) on the risk of hepatocellular carcinoma (HCC)
is well established in patients with genetic hemochromatosis or HCC developed on
non-cirrhotic liver. However, the influence of HIO on the risk of occurrence of HCC in other
chronic liver disease (including alcoholic and viral C) has been controversial. Recently, a
prospective study including a large population of patients with cirrhosis (n = 301)
classified according to the aetiology of liver disease (alcohol, n = 162 or hepatitis C
virus (HCV)infection, n = 139) has shown the association between HIO and the occurrence of
HCC in patients with alcoholic cirrhosis. Thus, the assessment of liver iron in routine
clinical practice could allow the identification of patients at higher risk of developing
HCC and in whom preventive measures such as iron depletion by phlebotomy could be
undertaken. Based on the model of genetic hemochromatosis in which its effectiveness on
survival improvement and even regression of hepatic injury has been shown, its effectiveness
on the prognosis and prevention of HCC occurrence in patients with alcoholic cirrhosis must
now be studied in prospective multicentre randomized trials.
The main objective of the study is to assess in patients with compensated alcoholic
cirrhosis and HIO, as assessed by MRI, the effect of phlebotomy in order to lower and
maintain serum ferritin below 50 µg / l on the risk of HCC occurrence. The effect of
bloodletting will be jointly evaluated on 1) episodes of hepatic decompensation, 2) non HCC
liver-related mortality 3) changes in HIO during follow-up.
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification:
Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose:
Prevention
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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