Skip to main content
OpenTrials
Completed

NCT Number: NCT05244720

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Zealand University Hospital

Køge, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FibroScan

Diagnostic Test

A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.

Other names: Transient elastography

Blood samples

Diagnostic Test

Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.

Primary outcomes

  1. Recruitment

    Time frame: 6 months

    >50% of those invited to participate gives written consent.

  2. Retention

    Time frame: 6 months

    >50% of those recruited and randomized to an examination, will attend for an examination at the hospital

  3. Completion

    Time frame: 6 months after randomization

    >50% of randomized patients complete follow-up

Secondary outcomes

  1. Reduction in Number of heavy drinking days

    Time frame: 10 months

    Reduction in Number of heavy drinking days, data collected at follow-up after 6 months, compared to baseline data.

  2. Abstinence or reduction in alcohol consumption

    Time frame: 10 months

    Abstinence from alcohol in the three months prior to the 6-months follow-up phone call.

  3. Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment

    Time frame: 6 months

    Results from fibroscan, with a mean value of >8 indicating fibrosis and a mean value of >15 indicating cirrhosis.

  4. Reduction in AUDIT score

    Time frame: 10 months

    AUDIT score is reported at baseline, and again at the 6 months follow up phone call.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.