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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03508388

Acronym

PROLIV

Enrollment

142

Registered

2018-04-25

Start date

2018-04-25

Completion date

2020-11-11

Last updated

2022-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Cirrhosis, Alcoholic Liver Disease

Keywords

Liver volume, Alcoholic cirrhosis, Liver transplantation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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* Adult patients * Patient suffering from alcoholic cirrhosis (withdrawn or not) * Patient admitted in emergency for an alcoholic cirrhosis decompensation only * Prescription for a cutting imaging (CT scan or MRI) during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

Design outcomes

Primary

Measure	Time frame
All cause mortality or liver transplantation	1 year

Countries

France

Outcome results