About this trial
Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver disease is now the 3rd leading cause of premature death in the United Kingdom. The majority of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes, injecting drug use) and therefore reversible if caught at a precirrhosis stage. However, current liver function blood tests are poor inadequate, and subsequently a large burden of liver disease is currently missed.
A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed which identify liver disease accurately at earlier stages of scarring. The identification of liver disease in the community, where previous studies have discovered a large burden of previously unidentified but significant liver disease, is therefore a feasible place to develop new liver disease investigation pathways using these noninvasive markers.
In collaboration with the Department of Health, Nottingham University Hospitals have commenced a pilot community liver disease pathway in two General Practices in Nottingham in February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2 diabetes)are invited to take part in the pathway. Patients undergo a simple blood test (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan values are reviewed by a consultant liver specialist in a community liver clinic. Preliminary findings show that the pathway accurately identifies patients with early liver scarring and previously unidentified significant liver disease. The participating General Practitioners have also noted a striking number of patients finally engaging in important lifestyle changes following pathway implementation. A second phase of the pilot pathway, in 2 Inner City General Practices with a total practice population of c.14,000 patients commenced in June 2013.
We have subsequently designed this cohort study, where pilot participants will be consented for follow up over a long period. We will assess future liver-related and cardiovascular events (including death), and perform qualitative patient interviews to assess the reasons for and persistence of lifestyle changes after liver disease investigation. We hypothesize that stratification of liver disease in the community will unearth a significant amount of previously undetected but significant chronic liver disease. Moreover, we will evaluate whether stratification of liver disease using these tests predicts future liver and cardiovascular disease and death, and whether stratification has an impact on patient's future lifestyle choices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hazardous alcohol use (>14 units/week for women, >21 units/week for men)
Type 2 Diabetes
Obesity
Persistently elevated ALT with normal liver serology
Disqualifiers
Active malignancy at study enrolment
Inability to provide informed consent for study enrolment
Known presence of histologically proven liver disease prior to pilot pathway participation
Trial population
A Primary Care database search (Systmone, TPP)will be performed to identify patients eligible for study (see inclusion criteria) in the discrete patient populations.
Trial design
Cohort
Prospective
Treatments tested in this trial
Fibrosis Biomarkers
DeviceLiver disease stratification with liver stiffness scan (Transient Elastography) Analysis of diagnostic performance of serum fibrosis markers (as listed above) Whole blood samples obtained for DNA analysis
Treatment groups
Trial outcomes
Primary outcomes
Liver and cardiovascular-related mortality
Death recorded as resulting from cardiovascular or liver-related causes
Secondary outcomes
Liver Cirrhosis
Incidence of compensated and decompensated cirrhosis diagnosis during the study period.
Cardiovascular Disease
Incidence of cardiovascular disease events(defined as symptomatic coronary or cerebrovascular disease)during the study period.
All-cause mortality
Recording of any death during the study period
Sponsors and contacts
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