The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Liver and cardiovascular-related mortality
研究概览
简要总结
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.
详细描述
Objectives:
- To establish a community based cohort with risk factors for liver disease and stratification for liver disease severity using non-invasive biomarkers.
- To establish the incidence of liver and cardiovascular morbidity and mortality in a community cohort.
- To explore the quantitative and qualitative indicators to potential alterations in patient lifestyle following stratification of liver disease to inform future intervention development.
- To evaluate novel blood markers of liver fibrosis and cirrhosis on a large cohort of primary care patients
Study Configuration:
Longitudinal Cohort Study with long-term follow up
Setting:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Persistently elevated ALT with normal liver serology
排除标准
- •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
结局指标
主要结局
Liver and cardiovascular-related mortality
时间窗: 20 years
Death recorded as resulting from cardiovascular or liver-related causes
次要结局
- Liver Cirrhosis(20 years)
- Cardiovascular Disease(20 years)
- All-cause mortality(20 years)
