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

NCT03508388 | Terminated

• 1 other identifier: RECHMPL18_0022
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Cirrhosis; Alcoholic Liver Disease

Keywords

Liver volume; Alcoholic cirrhosis; Liver transplantation

Outcome Measures

Primary Outcomes (1)

• All cause mortality or liver transplantation

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients suffering from alcoholic cirrhosis, withdrawn or not, hospitalised for an acute decompensation

You may qualify if:

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• Patient suffering from alcoholic cirrhosis (withdrawn or not)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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University Hospital, Nīmes: collaborator
• Narbonne Hospital: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic; Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Jose URSIC BEDOYA, MD

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: April 25, 2018
• Study Start: April 25, 2018
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: December 19, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)