This prospective study aims to determine the presence of liver fibrosis in patients with alcohol overconsumption, investigate diagnostic and prognostic markers for diagnosing early fibrogenic disease by non-invasive and minimally invasive methods. The cohort consists of 450 patients with ongoing or prior chronic, excessive alcohol use. The non-invasive methods to be used are:
- Real-time quantitative shear wave elastography (a multi-dimensional method, which generate an atlas of the liver stiffness, so that the measurements can be made in the largest and stiffest area)
- Transient elastography (one-dimensional method)
- Protein Fingerprinting (blood samples analyzed for fibrosis markers)
- The Enhanced Liver Fibrosis test (an algorithm of three direct markers of fibrosis)
- M30 and M65 cytokine-18 based markers of apoptosis and necrosis
Liver biopsies are taken to ensure the correct diagnosis has been made.
This project is part of the GALAXY consortium (Gut-and-liver-axis in alcoholic liver fibrosis), which is exploring the role of the gut microbiome in alcoholic liver fibrosis to improve understanding, diagnosis, prevention and treatment of chronic liver disease. Additionally, the following projects are also a part of the GALAXY consortium: OP_80 and OP_239.
Data and biological material
The project includes data from baseline inclusion, one follow up visit 12 months or more from baseline and clinical outcome data from patient files. Data is up loaded to OPEN Projects. There are data from blood analysis, histology, questionnaires and imaging diagnostics. Data is linked to register data from The Receipt Register, The Register of Cause of Death and The Danish Cancer Registry. Besides blood and liver samples for standard analyses, blood, liver tissue, saliva, feces and urine samples are collected for biobanking.
Publications associated with the project
Transient and 2-Dimensional Shear-Wave Elastography Provide Comparable Assessment of Alcoholic Liver Fibrosis and Cirrhosis. / Thiele M, Detlefsen S, Sevelsted Møller L, Madsen BS, Fuglsang Hansen J, Fialla AD, Trebicka J, Krag A. Gastroenterology. 2016 Jan; 150(1): 123-33.
Reliability Criteria for Liver Stiffness Measurements with Real-Time 2D Shear Wave Elastography in Different Clinical Scenarios of Chronic Liver Disease. / Thiele M, Madsen BS, Procopet B, Hansen JF, Møller LMS, Detlefsen S, Berzigotti A, Krag A. Ultraschall in Med. 2016.
Feasibility of transient elastography versus real-time two-dimensional shear wave elastography in difficult-to-scan patients. / Staugaard B, Christensen PB, Mössner B, Hansen JF, Madsen BS, Søholm J, Krag A, Thiele M. Scandinavian Journal of Gastroenterology, 2016, Jun 16:1-
Accuracy of the Enhanced Liver Fibrosis Test vs Fibrotest, Elastography and Indirect Markers in Detection of Advanced Fibrosis in Patients with Alcoholic Liver Disease. Thiele M, Madsen BS, Hansen JF, Detlefsen S, Antonsen S, Krag A. Gastroenterology. 2018 Jan 6. pii: S0016-5085(18)30016-7. doi: 10.1053/j.gastro.2018.01.005.
Controlled attenuation parameter and alcoholic hepatic steatosis: Diagnostic accuracy and role of alcohol detoxification.Thiele M, Rausch V, Fluhr G, Kjærgaard M, Piecha F, Mueller J, Straub BK, Lup?or-Platon M, De-Ledinghen V, Seitz HK, Detlefsen S, Madsen B, Krag A, Mueller S.J Hepatol. 2018 Jan 16. pii: S0168-8278(18)30016-3. doi: 10.1016/j.jhep.2017.12.029.
Transient elastography for screening of liver fibrosis: costeffectiveness analysis from six prospective cohorts in Europe and Asia. Serra-Burriel, M., Graupera, I., Torán, P., Thiele, M., Roulot, D., Wong, V.W-S., Guha, I.N., Fabrellas, N., Arslanow, A., Expósito, C., Hernández, R., Wong, G.L-H., Harman, D., Murad, S.D., Krag, A., Pera, G., Angeli, P., Galle, P., Guruprasad, A., Caballeria, L., Castera, L., Ginès, P., Lammert, F., on behalf of the investigators of the LiverScreen Consortium, Journal of Hepatology (2019), doi: https://doi.org/10.1016/j.jhep.2019.08.019
Cost?Effectiveness of Noninvasive Screening for Alcohol?Related Liver Fibrosis. Asphaug, L., Thiele, M., Krag, A. and Melberg, H.O. (2020), Hepatology, 71: 2093-2104. doi:10.1002/hep.30979
Spleen stiffness to liver stiffness ratio significantly differs between ALD and HCV and predicts disease-specific complications. Elshaarawy O, Mueller J, Guha IN, et al. JHEP Rep. 2019;1(2):99-106. Published 2019 Jun 21. doi:10.1016/j.jhepr.2019.05.003
Prediction of liver fibrosis severity in alcoholic liver disease by human microfibrillar-associated protein 4. Madsen BS, Thiele M, Detlefsen S, et al. Liver Int. 2020;40(7):1701-1712. doi:10.1111/liv.14491