Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial

Zealand University Hospital

Status: Completed

Conditions: Liver Diseases

Treatments: Diagnostic Test: Fibroscan; Diagnostic Test: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT05244720

SJ-934

Details and patient eligibility

About

This pilot study aims to evaluate the feasibility of a non-blinded randomized controlled trial with a parallel group design of an invitation to an evaluation of liver disease (intervention) compared to standard care with no invitation, among individuals in alcohol abuse treatment.

Full description

Alcohol-related liver disease (ALD) is responsible for about 80% of all liver disease in Denmark. The prognosis for ALD is good, if detected early and abstinence is obtained. Unfortunately ALD is often diagnosed at a late state and the 1-year survival is only 30%.

Currently there is no available systematic screening for fibrosis/cirrhosis among patients with longterm abuse of alcohol and thereby high risk for developing ALD.

Transient elastography (TE) is a non-invasive, risk free and quick method of detecting fibrosis. TE is validated for diagnosing fibrosis and ruling out cirrhosis.

40 patients will be enrolled in the study with a 1:1 randomization. Baseline data is collected and informed concent is obtained at the local alcohol abuse treatment center, Novavi Køge. The fibroscan and blood samples are done at Zealand University Hospital, Køge. Follow-up is done after 6 months, by a project nurse, blinded to the intervention.

If the study proves to be feasible, our aim is to extend the study in order to investigate wether the interventions described above, could help decrease alcohol consumption/maintain abstinence for patients in alcohol treatment. Moreover the prevalence of fibrosis and cirrhosis found by fibroscan is examined.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must be enrolled at alcohol treatment center Novavi Koege, Denmark
• Maximum 6 months of treatment at Novavi Koege

Exclusion criteria

• known severe liver disease
• life expectancy less than 6 months
• unable to give informed written consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

Baseline questionnaire filled out at recruitment. Invited to an examination of the liver, by fibroscan and blood samples, shortly after recruitment. Follow-up by phone after 6 months.

Treatment:

Diagnostic Test: Fibroscan

Diagnostic Test: Blood samples

Control

Other group

Description:

Baseline questionnaire filled out at recruitment. Follow-up by phone after 6 months. Invited to an optional examination of the liver, by fibroscan and blood samples, after 6 months.

Treatment:

Diagnostic Test: Fibroscan

Diagnostic Test: Blood samples