Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05244720
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2022-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
Sponsor:
Zealand University Hospital
Organization:
Study Overview
Official Title:
Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: