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Advanced Chronic Liver Disease Screening by Transient Elstography in Patients Hospitalised in a Psychiatric Unit (HEPSY)

Primary Purpose

Psychiatric Disorder, Psychiatric Hospitalization, Advanced Chronic Liver Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychiatric Disorder focused on measuring psychiatric disorders, advanced liver disease, alcoholic liver diseases, viral hepatitis, transient elastography (Fibroscan ®)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria adults ≥18 years having a psychiatric condition and hospitalized in a psychiatry unit of CHU Montpellier , France patients who lack capacity of consent if legal representative consents involuntary psychiatric hospitalization, if consent is given Exclusion criteria lack of written consent Unable to understand nature and objective of the methodology Pregnant or breast feeding woman Not affiliated with a French social security

Sites / Locations

  • Montpellier University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychiatric patient

Arm Description

All patients having psychiatric disorders and hospitalised in a Psychiatry Unit of CHU Montpellier will have an non invasive evaluation of liver fibrosis after giving their consent

Outcomes

Primary Outcome Measures

acceptability of non invasive assessement of liver fibrosis by Fibroscan in psychiatric patients
Number of patient who have agreed to do fibroscan screening among patient to whom it was offered.

Secondary Outcome Measures

Prevalence of advanced liver disease in psychiatric patients
Number of patient who are diagnosed with advanced liver disease among patient to whom it was offered.
prevalence of excessive alcohol or drug consumption in psychiatric patients
Number of patient with excessive alcohol/drug consumption
prevalence of passed or active drug consumption (intraveinous, inhaled or sniffed) in psychiatric patients
Number of patient with excessive alcohol/drug consumption
prevalence of viral hepatitis in psychiatric patients
Number of patient diagnosed with viral hepatitis B, D, C
correlation between advanced chronic liver diseases and risk factors for liver diseases in psychiatric patients
Number of patients with advanced chronic liver disease among those having risk factors for chronic liver disease
assessment of referral to medical care when advanced fibrosis was diagnosed, regardless of its etiology
Number of patients that have actually came to their medical appoint after advanced fibrosis diagnosis
reason for refusal of non invasive evaluation of chronic liver disease
rate of reasons of refusal according to reason of hospitalization, sector, duration of hospitalization, time spend in study explaination, patient reflection time

Full Information

First Posted
October 28, 2022
Last Updated
October 28, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05602870
Brief Title
Advanced Chronic Liver Disease Screening by Transient Elstography in Patients Hospitalised in a Psychiatric Unit
Acronym
HEPSY
Official Title
Acceptability of Advanced Chronic Liver Disease Screening by Transient Elstography (Fibroscan ®) in Patients Hospitalised in Psychiatric Unit: a Single Center Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders. There are still many barriers to screening and linkage to care for patients having somatic illness. Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs. The aim of this study is to asses acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in a psychiatric unit.
Detailed Description
Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders. There are still many barriers to screening and linkage to care for patients having somatic illness. Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs. Transient elastography is a useful tool validated for early diagnosis advanced chronic liver disease.It is non-invasive, fast, and gives immediate results. The aim of this study is to assess acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in psychiatric unit. Moreover, we will estimate de prevalence of advanced chronic liver diseases according to specific causes in psychiatry unit We hypothesize that the fact of offering psichiatric patents a non-invasive analysis of hepatic fibrosis will improve the detection of serious liver diseases and linkage to care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder, Psychiatric Hospitalization, Advanced Chronic Liver Disease, Liver Fibrosis
Keywords
psychiatric disorders, advanced liver disease, alcoholic liver diseases, viral hepatitis, transient elastography (Fibroscan ®)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychiatric patient
Arm Type
Experimental
Arm Description
All patients having psychiatric disorders and hospitalised in a Psychiatry Unit of CHU Montpellier will have an non invasive evaluation of liver fibrosis after giving their consent
Intervention Type
Diagnostic Test
Intervention Name(s)
non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)
Intervention Description
A Fibroscan will be performed and the result will be given to the patient. A follow-up will be organized in the event of a diagnosis of severe fibrosis. If the serologies for hepatitis B and C cannont be recovered, patient will be able to benfit from a rapid diagnostic orientation test (TROD) (minimally invasive capillary venous sampling at the fingertip) for these 2 serologies.
Primary Outcome Measure Information:
Title
acceptability of non invasive assessement of liver fibrosis by Fibroscan in psychiatric patients
Description
Number of patient who have agreed to do fibroscan screening among patient to whom it was offered.
Time Frame
At Inclusion
Secondary Outcome Measure Information:
Title
Prevalence of advanced liver disease in psychiatric patients
Description
Number of patient who are diagnosed with advanced liver disease among patient to whom it was offered.
Time Frame
At inclusion
Title
prevalence of excessive alcohol or drug consumption in psychiatric patients
Description
Number of patient with excessive alcohol/drug consumption
Time Frame
At inclusion
Title
prevalence of passed or active drug consumption (intraveinous, inhaled or sniffed) in psychiatric patients
Description
Number of patient with excessive alcohol/drug consumption
Time Frame
At Inclusion
Title
prevalence of viral hepatitis in psychiatric patients
Description
Number of patient diagnosed with viral hepatitis B, D, C
Time Frame
At Inclusion
Title
correlation between advanced chronic liver diseases and risk factors for liver diseases in psychiatric patients
Description
Number of patients with advanced chronic liver disease among those having risk factors for chronic liver disease
Time Frame
1 to 3 month after inclusion
Title
assessment of referral to medical care when advanced fibrosis was diagnosed, regardless of its etiology
Description
Number of patients that have actually came to their medical appoint after advanced fibrosis diagnosis
Time Frame
1 to 3 month after inclusion
Title
reason for refusal of non invasive evaluation of chronic liver disease
Description
rate of reasons of refusal according to reason of hospitalization, sector, duration of hospitalization, time spend in study explaination, patient reflection time
Time Frame
At Inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria adults ≥18 years having a psychiatric condition and hospitalized in a psychiatry unit of CHU Montpellier , France patients who lack capacity of consent if legal representative consents involuntary psychiatric hospitalization, if consent is given Exclusion criteria lack of written consent Unable to understand nature and objective of the methodology Pregnant or breast feeding woman Not affiliated with a French social security
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helene DONNADIEU, MD
Phone
+334 67 33 70 20
Email
h-donnadieu_rigole@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena MESZAROS, MD
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene DONNADIEU, MD

12. IPD Sharing Statement

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Advanced Chronic Liver Disease Screening by Transient Elstography in Patients Hospitalised in a Psychiatric Unit

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