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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03508388
Other study ID # RECHMPL18_0022
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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Eligibility Inclusion Criteria: - Adult patients - Patient suffering from alcoholic cirrhosis (withdrawn or not) - Patient admitted in emergency for an alcoholic cirrhosis decompensation only - Prescription for a cutting imaging (CT scan or MRI) during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

Study Design


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
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