Value on Survival of Liver Volume After an Acute Decompensation of an Alcoholic Cirrhosis

Terminated

• Conditions: Alcoholic Liver Disease; Alcoholic Cirrhosis

• Registration Number: NCT03508388
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). Our hypothesis is that patients with a "small" liver have a lower survival compared to patients having a "normal" sized liver.

Detailed Description

In this observational, prospective and multicentre clinical trial, investigator seek to determine the prognostic value of liver volume during an acute decompensation. Investigator plan to enroll admitted adult patients with acute decompensation of an alcoholic cirrhosis (abstinent or not), followed for one year or until death or liver transplantation. Liver volume will be evaluated using CT-scan or MRI reconstructions.

Study Timeline

• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-04-23
• Study Start: 2018-04-25
• Study First Posted: 2018-04-25
• Status Verified: 2020-01
• Primary Completion: 2020-11-11
• Study Completion: 2020-11-11
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Adult patients
• Patient suffering from alcoholic cirrhosis (withdrawn or not)
• Patient admitted in emergency for an alcoholic cirrhosis decompensation only
• Prescription for a cutting imaging (CT scan or MRI) during hospitalisation
• Alcohol consumption of more than 3 units per day for men and 2 units for women in average, over at least the last 5 years before the cirrhosis diagnosis
• Patient suffering from decompensated cirrhosis defined by at least one of the following criteria : Model For End-Stage Liver Disease (MELD) score above or equal to 15, ascites needing iterative punctures, symptomatic bacterial ou fungal infections, acute digestive bleeding due to portal hypertension, hepatic encephalopathy defined by a West Haven score above or equal to 2

Exclusion Criteria

• Nodule with typical criteria of hepatocellular carcinoma
• B or C viral infections actives
• Presence of transjugular intrahepatic portosystemic shunt (TIPS)
• Presence of an occlusive thrombosis of the porta or one of the principal branches
• Presence of a thrombosis of the sus-hepatic vein
• Active extra-hepatic malignant tumor
• Decompensated cardio-vascular disease
• Patient unwilling to participate to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality or liver transplantation	1 year

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France