The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients aged 18 years or over (male or female) with primary risk factor for liver disease:

‣ Hazardous alcohol use (\>14 units/week for women, \>21 units/week for men)

⁃ Type 2 Diabetes

⁃ Obesity

⁃ Persistently elevated ALT with normal liver serology

Locations
Other Locations
United Kingdom
NIHR Nottingham Digestive Diseases Biomedical Research Unit
RECRUITING
Nottingham
Time Frame
Start Date: 2013-05
Estimated Completion Date: 2033-05
Participants
Target number of participants: 2000
Treatments
Patients
Patients identified with one of the below chronic liver disease risk factors and undergoing community liver disease stratification using fibrosis biomarkers:~* Hazardous alcohol use (\>14 units per week in females, \>21 units per week in males, alcohol AUDIT score \>=8 or read code relevant to alcohol abuse on GP system)~* Type 2 Diabetes~* Obesity~* Persistently raised serum ALT level, negative liver serology, and absence of above 2 risk factors
Related Therapeutic Areas
Sponsors
Leads: University of Nottingham

This content was sourced from clinicaltrials.gov