Value on Survival of Liver Volume After an Acute Decompen... | NCT03508388

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

NCT03508388

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Dec 19, 2022Actual

Enrollment

142Actual

Phase

Not provided

Conditions

Alcoholic Cirrhosis
Alcoholic Liver Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inclusion number not sufficient

Expanded Access Info

Start Date

Apr 25, 2018Actual

Primary Completion Date

Nov 11, 2020Actual

Completion Date

Nov 11, 2020Actual

First Submitted Date

Apr 23, 2018

First Submission Date that Met QC Criteria

Apr 23, 2018

First Posted Date

Apr 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2022

Last Update Posted Date

Dec 19, 2022Actual

Name	Class
University Hospital, Nīmes	UNKNOWN
Narbonne Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Measure	Description	Time Frame
All cause mortality or liver transplantation		1 year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Jose URSIC BEDOYA, MD	UH Montpellier	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Montpellier University Hospital		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008104	Liver Cirrhosis, Alcoholic
D008108	Liver Diseases, Alcoholic

Ancestor Terms

ID	Term
D008103	Liver Cirrhosis
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided