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

NCT ID: NCT03508388

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-25
• Study Completion Date: 2020-11-11

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.

Conditions

Alcoholic Cirrhosis; Alcoholic Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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• Patient suffering from alcoholic cirrhosis (withdrawn or not)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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Nīmes

UNKNOWN

Sponsor Role: collaborator

Narbonne Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose URSIC BEDOYA, MD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

Montpellier University Hospital

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL18_0022

Identifier Type: -

Identifier Source: org_study_id