Clinical Trial: National Cohort of Uncomplicated Alcoholic Cirrhosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: CIRRAL: Hepatocellular Carcinoma in Patients With Uncomplicated Alcoholic Cirrhosis: Incidence and Predictive Factors. A Multicentric Prospective Cohort

Brief Summary: Hepatocellular carcinoma (HCC) is a major public health problem, whose incidence is increasing in developed countries and is the leading cause of death in patients with cirrhosis. The diagnosis and the early management are key issues that could improve the prognosis. In France, alcoholic cirrhosis is the leading cause of HCC, while the aetiology of underlying chronic liver disease is mainly hepatitis C (HCV) in Southern Europe and Japan, and hepatitis B (HBV) in Asia and Africa. In the next years, due to the improved results of anti-viral therapies, this trend should be reinforced with a decreasing proportion of HCC related to viral cirrhosis and an increasing proportion of HCC related to alcoholic cirrhosis. However, natural history of alcoholic cirrhosis remains poorly understood, most studies being retrospective and including a small number of patients. This project is filed by the consortium CIRRAL including French Academic hospitals centers currently involved and referees in the field of alcoholic liver disease and HCC (8 at the moment, and more in the next months). It is a national multicenter prospective study that will include 1200 patients with alcoholic cirrhosis histologically proven over 3 years. The main goal of this cohort is to describe the natural history of a large number of patients with alcoholic cirrhosis prospectively followed, and to identify predictors of the occurrence of HCC.

Detailed Summary:

Patients will be selected for the study if they met all the inclusion criteria, without any of the non-inclusion criteria, ie compensated Child Pugh A alcoholic cirrhosis without viral chronic hepatitis B or C, and without any detectable HCC. They will be offered, during a consultation as part of their usual care, to participate in the study. An information note will be issued. Patients agreeing to participate should date and sign informed consent. Usual biological tests and liver ultrasonography will be performed if not done within 90 days prior to inclusion. During this visit, 20 ml of blood will be collected for freezing and storage of serum and plasma, and constitution of a DNA library.

From the reviews conducted at baseline, patients with at least one exclusion criteria (ie decompensation of cirrhosis, Child Pugh score ≥ 7, co-infection with HBV or HCV, or liver focal lesion suggestive of HCC will be excluded (and their serum samples achieved for the BioBank will be destroyed):

Monitoring: According to current guidelines, patients will have periodical surveillance with liver ultrasonography and medical consultation at least every 6 months, blood tests at least every year, periodic assessment of esophageal and gastric varices (every 1 to 3 years) and prevention of their rupture if any. An additional blood sampling of 20 ml will be taken at baseline and every year in order to perform serum, plasma, and DNA libraries; Data will be standardized and centralized in a single database.

Statistical Analysis: Methods for censored data with competitive risks. Number of subjects to include: The planned number is 1200 subjects included in 3 years. Assuming a minimal annual incidence of HCC about 2% in patients with alcoholic cirrhosis, and a proportion of lost to follow-up of
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: HCC Occurrence [ Time Frame: 3 years ]

cumulative incidence within 3 years


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: 3 years ]
    overall mortality - whatever the cause of death
  • Liver-related mortality [ Time Frame: 3 years ]
    cumulative incidence of liver-related deaths
  • Alcohol- and cirrhosis-related event free survival [ Time Frame: 3 years ]
    event free survival where events are ascitis, digestive hemorrhage, icterus, encephalopathy, non-liver events related to alcohol, bacterial infection and death free of those events


Original Secondary Outcome:

  • Mortality [ Time Frame: 3 years ]
    overall mortality - whatever the cause of death
  • Liver-related mortality [ Time Frame: 3 years ]
    cumulative incidence of liver-related deaths


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: October 1, 2010
Date Started: October 2010
Date Completion: October 2017
Last Updated: November 18, 2016
Last Verified: November 2016