The Liver Care Trial

Zealand University Hospital

Status: Enrolling

Conditions: Alcoholism; Fibrosis, Liver; Alcoholic Liver Disease; Alcohol Abuse; Alcohol Use Disorder; Alcohol-Related Disorders

Treatments: Diagnostic Test: Transient Elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT05855031

SJ-995

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.

Enrollment: 408 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde
• Informed written consent

Exclusion criteria

• Not speaking Danish or English
• Severe liver disease (known by the participant)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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408 participants in 2 patient groups

Intervention

Experimental group

Description:

An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.

Treatment:

Diagnostic Test: Transient Elastography

Control

No Intervention group

Description:

An invitation to screening by blood sampling with Fib-4