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

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ClinicalTrials.gov Identifier: NCT03508388
Recruitment Status : Unknown
Verified January 2020 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : April 25, 2018
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
University Hospital, Nīmes
Narbonne Hospital
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.

Condition or disease
Alcoholic Cirrhosis Alcoholic Liver Disease

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 Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Liver Volume on Acute Decompensation of Alcoholic Cirrhosis, a Prospective Multicenter Observational Study
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. All cause mortality or liver transplantation [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients suffering from alcoholic cirrhosis, withdrawn or not, hospitalised for an acute decompensation
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508388


Contacts
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Contact: Jose URSIC BEDOYA, MD 0467337390 j-ursicbedoya@chu-montpellier.fr

Locations
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France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Contact: José URSIC BEDOYA, M.D.    +33-467337390    j-ursicbedoya@chu-montpellier.fr   
Contact: José URSIC BEDOYA, MD         
Principal Investigator: Magdalena MESZAROS, MD         
Principal Investigator: Ludovic CAILLO, MD         
Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Nīmes
Narbonne Hospital
Investigators
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Principal Investigator: Jose URSIC BEDOYA, MD UH Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03508388    
Other Study ID Numbers: RECHMPL18_0022
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Liver volume
Alcoholic cirrhosis
Liver transplantation
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Liver Diseases, Alcoholic
Liver Cirrhosis, Alcoholic
Fibrosis
Pathologic Processes
 Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders