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

December 14, 2022 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients suffering from alcoholic cirrhosis, withdrawn or not, hospitalised for an acute decompensation

Description

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  • Patient suffering from alcoholic cirrhosis (withdrawn or not)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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality or liver transplantation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Narbonne Hospital
University Hospital, Nîmes

Investigators

  • Principal Investigator: Jose URSIC BEDOYA, MD, UH Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Actual)

November 11, 2020

Study Completion (Actual)

November 11, 2020

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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