Primary objective: 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.Secondary Objectives:- To investigate patient satisfaction…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome *proportion of patients with suspected NAFLD incurring liver
related hospital consultations and/or liver biopsies
Secondary outcome
- Patient feedback from qualitative research using a questionnaire
- Clinical outcome measures will be metrics reported by the scan * liver iron,
liver fat, cardiovasculaire status and the Liver Inflammation Fibrosis score
(cT1 value) * compared to histology and /or non invasive test results in
patients in the control arm
- Certainty of diagnosis is defined as a binary (yes/no vs. unlikely/probable)
and frequency as (yes/probable vs. no/unlikely)
- Time from randomisation to diagnosis by the physician.
- Rates of consultations, investigations, admissions
- Cost-effectiveness of LiverMultiScan based on randomised comparison
- Personnel required to perform procedures and tasks
Background summary
Non-alcoholic fatty liver disease (NAFLD) is a spectrum of disease from fatty
liver to non-alcoholic steatohepatitis, fibrosis, and cirrhosis. At the last
advanced end of the spectrum, non-alcoholic fatty liver (NAFL) is an excess of
fat in the liver (steatosis) present in 20-30% of the general population and is
largely asymptomatic. In around 5-6% of patients with NAFL only the condition
progresses to non-alcoholic steatohepatitis (NASH), fibrosis, or cirrhosis. In
this small group there is a risk of death from liver failure or hepatocellular
carcinoma, or needing a liver transplant. The number of hospital admissions for
liver damage at the more severe end of the NAFLD spectrum, fibrosis and
cirrhosis, are increasing every year.
Study objective
Primary objective:
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.
Secondary Objectives:
- To investigate patient satisfaction with LiverMultiScan instead of existing
care (with other liver investigations)
- To confirm the correlations between LiverMultiScan and liver biopsy results
using AUC, PPV and NPV
- To investigate certainty and frequency of diagnosis at points of time in the
patient pathway.
- To investigate which pathway was quicker to get to the diagnosis as recorded
at final follow-up visit? (including all corrections and additional
investigations).
- To measure what healthcare was used in the two diagnostic pathways and
subsequent follow-up
- To investigate skills/specialisation required
Study design
This will be a multicentre phase 4 randomised controlled trial to determine the
implementation and health care cost of LiverMultiScan versus routine methodical
assessment of NAFLD (control arm) in different EU territories. Randomisation is
essential in that it will minimise clinician biases over referral practises.
Each patient referred to be evaluated for suspected fatty liver disease will be
randomised to either a current management arm, as per local guidelines and
choices, or to a second arm, where patient assessment begins with a
LiverMultiScan requested by the hepatologist in charge of the NAFLD programme
at each centre. Patients will attend for one dedicated study visit after which
they will be followed up for a minimum of 12 months, either when they attend
for routine clinic appointments, or by telephone, post, email, and/or personal
visit. Additional permission will be asked to donate blood for biobanking. For
the final assessment liver function test and NAS score have to be checked by GP
or appropriate clinician.
Study burden and risks
There are no anticipated risks associated with this study. The patients will
not recieve any direct benefit from participation. There is no gurantee or
promise that patients will recieve any benefits from this study.
Oxford Centre For Innovation, new Rd 1
Oxford OX1 1BY
GB
Oxford Centre For Innovation, new Rd 1
Oxford OX1 1BY
GB
Listed location countries
Age
Inclusion criteria
* Male and female patients aged 18-75, due to undergo evaluation for suspected
non-alcoholic fatty liver disease
* Participant is willing and able to give informed consent for participation in
the study.
* Within standard of care presence of:
- elevated liver function tests (ALT, AST or GGT * 1.5 x upper limit of normal
and ALT, AST * 5 x upper limit of normal) up to 1 year prior to patient
recruitment
OR
- imaging suggestive of Fatty liver disease up to 3 years prior to patient
recruitment OR
Presence of * 3 of the following criteria at screening::
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)
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60844.058.17 |