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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Unknown status

CT.gov ID

NCT03508388

Collaborator

University Hospital, Nīmes (Other), Narbonne Hospital (Other)

150

Enrollment

Location

37.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Cirrhosis Alcoholic Liver Disease

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prognostic Value of Liver Volume on Acute Decompensation of Alcoholic Cirrhosis, a Prospective Multicenter Observational Study

Actual Study Start Date :

Apr 25, 2018

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Outcome Measures

Primary Outcome Measures

All cause mortality or liver transplantation [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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Patient suffering from alcoholic cirrhosis (withdrawn or not)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