A Care Path for the Detection of Advanced NAFLD-fibrosis: the Nijmegen-Leiden-Amsterdam 2-tiered Care Path Study - the NLA2 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 655
- 试验地点
- 3
- 主要终点
- Diagnostic accuracy of the three different care paths to detect advanced fibrosis.
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is a liver disease, caused by storage of fat in the liver. The most-important risk-factors are being overweight, and disorders in sugar and cholesterol handling of the body. On average does around 30% of the population worldwide have any signs of fatty liver. Most people will not get severe complaints as a result of their fatty liver. But in some of them, the fat storage will lead to hepatitis. This causes damage to the liver which can eventually lead to scarring of the liver, and in some patients to cirrhosis. This possibly can cause liver failure, liver cancer, an several complaints which reduce the quality of life. There are several tests which can help in detecting scarring of the liver. However, the scientific world still does not know well enough which test works best and if they perhaps might work better if they are used together. In this study these questions will be investigated in order to design a care path which does several tests consecutively. The goal is that this will make it possible to easily detect a severely diseased liver and that this will eventually help to detect patients earlier so they can be treated earlier and complications of the disease might be reduced. Moreover, is the goal that this study will lead to a decrease in unnecessary referrals to a hepatologist, resulting in a reduction in invasive diagnostic interventions. Hospital specialists who think that their patient might be at risk for advanced liver disease, can refer a patient to this study. Participants will go to the hospital for one study visit where several tests will be done which are designed to detect liver scarring. Depending on the results, a participant will be referred to a hepatologist for more extensive diagnostics or referred back to the referring specialist with advice for management of the disease.
详细描述
Background of the study:
Non-alcoholic fatty liver disease (NAFLD) is a disease of alarmingly increasing prevalence. Progression along the NAFLD spectrum often goes unnoticed since it is often asymptomatic. Awareness among health care workers and implementation of care paths to detect progressing NAFLD stages are limited. Without clear guidance papers or robust care pathways for risk stratification, the current diagnostic approach for NAFLD is highly variable, leading to both underdiagnosis of advanced stages of disease, andunnecessary referrals for mild stages of disease. This calls for a comprehensive care path consisting of non-invasive alternatives to detect those patients with severe cases of NAFLD. Particularly the use of a sequential, two-tiered care path algorithm is promising as it has the ability to detect underlying advanced cases of fibrosis, and has previously been shown to be cost-effective. This was shown by dr. Ankur Srivastava, who designed a pathway consisting of FIB4-score and ELF-test that led to a reduction of unnecessary referrals to the hepatologist by 80%, whilst improving the detection of advanced fibrosis and cirrhosis 5- and 3-fold,respectively (8). In this study the investigation of several two-tiered sequential care path algorithms, comprised of the FIB4-score, VCTE and the ELF-test, for the detection of advanced stages of NAFLD-fibrosis is proposed: the Nijmegen-Leiden-AmsterdamNAFLD-NASH 2-tiered care path study: NLA2-study.
Objective of the study:
The aim of the study is to improve case finding of advanced cases of NAFLD (≥F3 fibrosis), whilst simultaneously reducing unnecessary referrals for mild cases (<F3 fibrosis). Additionally, the aim is to increase awareness of NAFLD, and NAFLD-related complications, and to assess the cost-effectiveness of the different proposed care paths compared to current regular care.
Study design:
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
- •Age ≥ 18 years;
- •Suspected by treating physician to suffer from a severe stage of NAFLD-fibrosis.
排除标准
- •Previous diagnosis of advanced (≥F3) liver fibrosis;
- •Any other known chronic liver disease (alcoholic steatohepatitis, hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1-antitrypsin deficiency);
- •Drugs that may cause drug-induced hepatic steatosis, (table provided elsewhere)
- •Present excessive alcohol use, defined as > 2 units/day for women and > 3 units/day for men;
- •A psychiatric, addictive or any other disorder that compromises the subject's ability to understand the study content and to give written informed consent for the participation in the study.
结局指标
主要结局
Diagnostic accuracy of the three different care paths to detect advanced fibrosis.
时间窗: The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later
The diagnostic accuracy of the three different sequential care path algorithms to detect underlying advanced (≥F3) liver fibrosis, assessed using sensitivity, specificity, predictive values and area under the receiver characteristics (AUROC) curve
Diagnostic performance of the three different care paths to increase correct and decrease incorrect referrals.
时间窗: The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later
The diagnostic performance of the three different sequential care path algorithms, defined as the increase in correct and the decrease in unnecessary referrals when using these care paths to detect underlying advanced (≥F3) NAFLD-fibrosis compared to regular care.
次要结局
- Cost effectiveness of the different diagnostic modalities/care path algorithms(The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later.)
- Number of patients coded for NAFLD before and after the study(through study completion, an average of 1 year)
- The diagnostic accuracy of the FIB4-score for detecting advanced fibrosis(The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later.)
- The diagnostic accuracy of the ELF-test for detecting advanced fibrosis(The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later.)
- The diagnostic accuracy of VCTE for detecting advanced fibrosis(The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later.)
- Diagnostic performance of the FIB4-score to increase correct and decrease incorrect referrals.(The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later.)
- Diagnostic performance of VCTE to increase correct and decrease incorrect referrals.(The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later.)
- Diagnostic performance of the ELF-test to increase correct and decrease incorrect referrals.(The time frame is based on the time between the study visit and the subsequent read-outs of the EHR, up to 24 months later.)
研究者
Onno Holleboom, MD, PhD
Vascular internist and endocrinologist, Assistant professor, Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)