Determining the optimum strategy for the detection of advanced liver disease in primary care interface

Not Applicable

• Conditions: Diseases of the liver; Digestive System

• Registration Number: ISRCTN31148824
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-21
• Last Update Posted: 9 September 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Individuals aged 18-80 years attending for an ‘annual review of care’, ‘chronic disease review’ or ‘health check’ with one or more of the following risk factors for liver disease:
1. Obesity (BMI > 30),
2. Type 2 diabetes
3. Potentially harmful alcohol consumption (AUDIT score > 8)

We have included an upper cut-off for the age of 80 for inclusion in this study. This is because liver disease generally has a slow progression to liver-related complications even with compensated cirrhosis, and as a result, asymptomatic individuals > 80 years are unlikely to benefit from early detection of liver disease.

Exclusion Criteria

1. Life limiting disease on high risk or palliative care register
2. Known liver disease under secondary care follow up
3. Refusal or inability (lack of capacity) to provide informed consent
4. Unable to understand or speak English

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients identified with advanced liver fibrosis/cirrhosis using each of the pathways based on an overall clinical evaluation by a panel of hepatologists measured using study records at a single time point

Secondary Outcome Measures

Name	Time	Method
1. Usefulness of non-invasive testing/triage strategies to identify patients who have liver-related events (death, hepatic decompensation, transplantation) during longitudinal follow-up at 2, 5 and 10 years measured using electronic care records/NHS Digital<br>2. Performance of FIB-4, ELF, PRO-C3 and other novel blood-based biomarkers alone or in combination measured using overall clinical assessment or LSM to identify advanced fibrosis/cirrhosis at a single timepoint<br>3. Performance of the biomarkers to correctly exclude advanced fibrosis/cirrhosis as defined by overall clinical assessment or LSM at a single timepoint<br>4. Development of the optimum pathway (clinically and cost-effective and implementable)