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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244720
• Other study ID #: SJ-934
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2022
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Liver Diseases

Intervention

Diagnostic Test:
• Fibroscan
A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.
• Blood samples
Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.

Locations

Country	Name	City	State
Denmark	Department of Medicine, Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	>50% of those invited to participate gives written consent.	6 months
Primary	Retention	>50% of those recruited and randomized to an examination, will attend for an examination at the hospital	6 months
Primary	Completion	>50% of randomized patients complete follow-up	6 months after randomization
Secondary	Reduction in Number of heavy drinking days	Reduction in Number of heavy drinking days, data collected at follow-up after 6 months, compared to baseline data.	10 months
Secondary	Abstinence or reduction in alcohol consumption	Abstinence from alcohol in the three months prior to the 6-months follow-up phone call.	10 months
Secondary	Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment	Results from fibroscan, with a mean value of >8 indicating fibrosis and a mean value of >15 indicating cirrhosis.	6 months
Secondary	Reduction in AUDIT score	AUDIT score is reported at baseline, and again at the 6 months follow up phone call.	10 months