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

Liver Fibrosis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05602870
• Other study ID #: RECHMPL22_0114
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2022
• Source: University Hospital, Montpellier
• Contact: Helene DONNADIEU, MD
• Phone: +334 67 33 70 20
• Email: h-donnadieu_rigole[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Chronic Liver Disease
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Psychiatric Hospitalization

Intervention

Diagnostic Test:
• non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)
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.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Inclusion
Secondary	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.	At inclusion
Secondary	prevalence of excessive alcohol or drug consumption in psychiatric patients	Number of patient with excessive alcohol/drug consumption	At inclusion
Secondary	prevalence of passed or active drug consumption (intraveinous, inhaled or sniffed) in psychiatric patients	Number of patient with excessive alcohol/drug consumption	At Inclusion
Secondary	prevalence of viral hepatitis in psychiatric patients	Number of patient diagnosed with viral hepatitis B, D, C	At Inclusion
Secondary	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	1 to 3 month after inclusion
Secondary	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	1 to 3 month after inclusion
Secondary	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	At Inclusion