Metabolic Syndrome, NAFLD, NASH - Nonalcoholic Steatohepatitis
Conditions
Brief summary
A multi-centre randomised controlled trial to determine the implementation and health care cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic fatty liver disease (NAFLD) across several European countries.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is a condition associated with obesity, insulin resistance and heart disease. Research has shown that fatty liver (steatosis) can lead to a spectrum of diseases including low grade inflammation (steatohepatitis or non-alcoholic steatohepatitis (NASH)), cirrhosis or liver failure. The current method used to diagnose liver dysfunction and failure is with percutaneous liver biopsy. This is painful and is not without risk, as the liver is a highly vascular organ. Even with ultrasound guidance, it carries a 1:1000 risk of serious adverse events (e.g. bleeding, infection, bowel perforation). As a result of these factors, liver biopsy is not used in all patients with suspected NAFLD/ NASH unless moderate to severe liver disease is presented or other liver disease need to be excluded. Various diagnostic pathways have arisen, but in the absence of a clearly non-invasive discriminatory test that can stratify normal liver, simple steatosis, steatohepatitis and cirrhosis, there is no standardised pathway. LiverMultiScan has been tested against liver biopsy and has been shown to be the first imaging test that can identify early liver disease and predict clinical outcomes accurately. LiverMultiScan has recently been CE-Marked and FDA-cleared, so is available for clinical use, but as a new test, it is not yet widely established in clinical practice. This study will utilise LiverMultiScan and see if it can be the basis of a viable diagnostic pathway in EU healthcare systems by adopting it in different EU countries, and determining the economic costs and benefits.
Interventions
DIAGNOSTIC_TESTLiverMultiScan
LiverMultiScan is an imaging technique which is able to identify early liver disease.
Sponsors
University of Coimbra
University Hospital Ulm
Leiden University Medical Center
Liverpool University Hospitals NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
King's College Hospital NHS Trust
NHS Greater Glasgow and Clyde
Glasgow Royal Infirmary
Ninewells Hospital
Royal Infirmary of Edinburgh
St George's University Hospitals NHS Foundation Trust
Perspectum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged 18-75 years, due to undergo evaluation for suspected non-alcoholic fatty liver disease * Presence of: * elevated liver function tests (ALT, AST or GGT ≥ 1.5 x upper limit of normal and ≤ 5 x upper limit of normal) OR * imaging suggestive of Fatty liver disease. OR Presence of ≥ 3 of the following criteria: 1. insulin resistance or type 2 diabetes mellitus 2. obesity (BMI \> 30 or waist-to-hip ratio \> 1.00 for men / \> 0.85 for women) 3. hypertension (≥ 130/85 mmHg) 4. elevated triglycerides (≥ 1.7 mmol/l) 5. low HDL-cholesterol (\< 1.05 mmol/l for men / \< 1.25 mmol/l for women) * Participant is willing and able to give informed consent for participation in the study.
Exclusion criteria
* The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia). * Patients with proven liver disease other than NAFLD. * Liver transplantation * Patients that present with clinical signs of chronic liver failure (variceal bleeding, ascites, overt encephalopathy) * Pregnancy * Alcohol over-use/ abuse as determined by local guidelines * Patient with known malignant liver tumours and those with any malignancy with life expectancy \< 36 months * Heart failure NYHA stages II-IV * Severe mental illness * Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can prove a cost-effective method in different EU territories. | 1 year | Proportion of patients with suspected NAFLD incurring liver related hospital consultations and/or liver biopsies, from the date of randomisation to the end of the study follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Certainty of diagnosis | 1 year | Certainty of diagnosis is defined as binary (yes/no vs. unlikely/probable) at baseline and all follow-up visits to the end of the study. |
| Frequency of diagnosis | 1 year | Frequency of diagnosis is defined as binary (yes/probable vs. no/unlikely) at baseline and all follow-up visits to the end of the study. |
| Time to diagnosis | 1 year | Time from randomisation to diagnosis by the physician, as recorded at final follow-up visit. |
| Patient satisfaction: questionnaire | 1 year | Patient feedback from patient satisfaction questionnaire, at baseline, and all follow-up visits to the end of the study. |
| Cost effectiveness of LiverMultiScan | 1 year | Cost of LiverMultiScan based on randomised comparison. |
| Personnel skills required for diagnosis | 1 year | Percentage of total consultations performed by a specialist, at each specialist medical category, from date of randomisation to end of study. |
| Measure resource use | 1 year | Rates of liver related outpatient investigations/consultations/hospital admissions per 400 patients during the study. |
Countries
Germany, Netherlands, Portugal, United Kingdom
Outcome results
None listed