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

Alcoholic Liver Disease Clinical Trial

— PROLIV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03508388
• Other study ID #: RECHMPL18_0022
• Status: Terminated
• Start date: April 25, 2018
• Est. completion date: November 11, 2020

Study information

• Verified date: January 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Patient suffering from alcoholic cirrhosis (withdrawn or not)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

Related Conditions & MeSH terms

• Alcoholic Cirrhosis
• Alcoholic Liver Disease
• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic
• Liver Diseases
• Liver Diseases, Alcoholic

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Narbonne Hospital, University Hospital, Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality or liver transplantation		1 year