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

NCT05602870 | Completed DMC

• 1 other identifier: RECHMPL22_0114
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorder; Psychiatric Hospitalization; Advanced Chronic Liver Disease; Liver Fibrosis

Keywords

psychiatric disorders; advanced liver disease; alcoholic liver diseases; viral hepatitis; transient elastography (Fibroscan ®)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Prevalence of advanced liver disease in psychiatric patients

  At inclusion

• prevalence of excessive alcohol or drug consumption in psychiatric patients

  At inclusion

• prevalence of passed or active drug consumption (intraveinous, inhaled or sniffed) in psychiatric patients

  At Inclusion

• prevalence of viral hepatitis in psychiatric patients

  At Inclusion

• correlation between advanced chronic liver diseases and risk factors for liver diseases in psychiatric patients

  1 to 3 month after inclusion

Study Arms (1)

Psychiatric patient

EXPERIMENTAL

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

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

Interventions

non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®) DIAGNOSTIC_TEST

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.

Psychiatric patient

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, France

Location

MeSH Terms

Conditions

Mental Disorders; Liver Cirrhosis; Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: March 7, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

FR (1)