Clinical trial NCT03508388: Value on Survival of Liver Volume After an Acute Decompensation of an Alcoholic Cirrhosis
Official title: Prognostic Value of Liver Volume on Acute Decompensation of Alcoholic Cirrhosis, a Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alcoholic Cirrhosis
Alcoholic Liver Disease
Keywords: Liver volume
Alcoholic cirrhosis
Liver transplantation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University Hospital, Nīmes
name: Narbonne Hospital
First posted: 2018-04-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients suffering from alcoholic cirrhosis, withdrawn or not, hospitalised for an acute decompensation

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.

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* Patient suffering from alcoholic cirrhosis (withdrawn or not)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

Primary outcomes:
measure: All cause mortality or liver transplantation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: UH Montpellier
name: Jose URSIC BEDOYA, MD
role: PRINCIPAL_INVESTIGATOR
References: