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

NCT ID: NCT03508388

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-25

Study Completion Date

2020-11-11

Brief Summary

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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

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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.

Conditions

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Alcoholic Cirrhosis Alcoholic Liver Disease

Keywords

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Liver volume Alcoholic cirrhosis Liver transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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* Patient suffering from alcoholic cirrhosis (withdrawn or not)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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Nīmes

UNKNOWN

Sponsor Role collaborator

Narbonne Hospital

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose URSIC BEDOYA, MD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

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Montpellier University Hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0022

Identifier Type: -

Identifier Source: org_study_id