Diagnostic and Prognostic Performance of ELF results (DAPPER)
Research type
Research Study
Full title
A prospective cohort study of diagnostic and prognostic biomarkers of alcohol related liver disease
IRAS ID
245793
Contact name
William Rosenberg
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
The Enhanced Liver Fibrosis (ELF) test is a non-invasive assessment of liver fibrosis, currently recommended by the UK National Institute for Health and Care Excellence in the evaluation of patients with non-alcoholic fatty liver disease. We will perform the ELF test on patients admitted to hospital with Alcohol Related Liver Disease (ARLD) at the time of liver biopsy to determine the diagnostic performance of ELF in the assessment of liver fibrosis and the prognostic performance of ELF in the setting of acute presentations of ARLD. Consecutive patients undergoing liver biopsy for ARLD will have blood samples taken on the day of biopsy, at 30 days or at discharge, at 90 days after biopsy and at 1 year after biopsy. A nested cohort of 10 patients with alcoholic hepatitis will have their residual blood samples used to complete regular ELF tests during their inpatient stay. Data relating to alcohol consumption will be recorded for 90 days and patient records will be electronically linked for long-term follow up.
ELF test scores will be measured using the Siemens Advia Centaur platform. Liver biopsies will be assessed by a single liver pathologist. Long-term outcome data will be gathered through NHS digital. Statistical tests will be used to determine the diagnostic and prognostic performance of ELF for fibrosis assessment. The performance of ELF will be compared with histological scores of liver fibrosis and biochemical and haematological indices of liver fibrosis including AST to platelet ratio index.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0396
Date of REC Opinion
18 Jun 2018
REC opinion
Favourable Opinion