CARPA

Duración

02/06/2023 - 31/10/2025

Coordinador

Hospital Universitario Virgen del Rocío and ISGlobal, Spain

Financiadores

Echosens, Novo Nordisk and Siemens

Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as non-alcoholic fatty liver disease)¹ is the most widespread liver disease globally, with an estimated prevalence of 32% among adults.² The prevalence of MASLD in Europe is estimated at 27%.³ Its prevalence in Spain is estimated at 26% among people between 15 and 85 years of age.⁴ Left unmanaged, MASLD can progress to metabolic dysfunction-associated steatohepatitis (MASH, formerly called non-alcoholic steatohepatitis)¹, which happens in an estimated 20% of cases⁵, and can lead to liver fibrosis, cirrhosis, and hepatocellular carcinoma.⁶

MASLD, a public health threat⁷, is considered the hepatic manifestation of metabolic syndrome (MetS) as it is associated with MetS components like overweight, obesity, insulin resistance, and altered blood lipid levels.^8–10 Even though several Spanish population-based studies showed that age and MetS are the most relevant factors associated with advanced fibrosis^11,12, and that about 5% of the general population have significant undetected fibrosis or established cirrhosis¹³, diagnosis of MASLD within healthcare settings is very low.¹⁴ This has led to calls for simple evaluation tools that can be easily implemented in primary care settings to ensure the early diagnosis and management of MASLD.¹⁵ 

The Clinical Care Pathway Assessment (CARPA) study aims to assess the implementation of a novel clinical pathway (Figure 1) in 10 primary care and correspondent tertiary/specialist (hepatology/endocrinology) centres across Spain, to increase detection and treatment of MASLD. The aim is to screen over 7000 people at risk of MASLD-fibrosis across all centres.

Figure 1. Clinical pathway

Abbreviations: ELF, Enhanced Liver Fibrosis; FIB-4, Fibrosis-4; MASLD, metabolic dysfunction-associated steatotic liver disease; MetS, metabolic syndrome; TE, transient elastography (FibroScan); T2D, type 2 diabetes.

The participating centres are:

• Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Galicia
• Hospital General Universitario de Valencia, Valencia, Comunidad Valenciana
• Hospital Universitario de Canarias, Santa Cruz de Tenerife, Canarias
• Hospital Universitario La Paz, Madrid, Comunidad de Madrid
• Hospital Universitario Miguel Servet, Zaragoza, Aragón
• Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Comunidad de Madrid
• Hospital Universitario Puerta del Mar, Cádiz, Andalucía
• Hospital Universitario Son Espases, Palma de Mallorca, Islas Baleares
• Hospital Universitario Vall d’Hebrón, Barcelona, Cataluña
• Hospital Universitario Virgen del Rocío, Sevilla, Andalucía

References

1. Rinella, M. E. et al. A multi-society Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol 78, 1966–1986 (2023).

2. Riazi, K. et al. The prevalence and incidence of NAFLD worldwide: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol 7, 851–861 (2022).

3. Cholongitas, E. et al. Epidemiology of nonalcoholic fatty liver disease in Europe: a systematic review and meta-analysis. Ann Gastroenterol 34, 404–414 (2021).

4. Aller, R. et al. Consensus document. Management of non-alcoholic fatty liver disease (NAFLD). Clinical practice guideline. Gastroenterol Hepatol 41, 328–349 (2018).

5. Estes, C., Razavi, H., Loomba, R., Younossi, Z. & Sanyal, A. J. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology 67, 123–133 (2018).

6. Lazarus, J. V et al. Advancing the global public health agenda for NAFLD: a consensus statement. Nat Rev Gastroenterol Hepatol 19, 60–78 (2022).

7. Tan, D. J. H. et al. Clinical characteristics, surveillance, treatment allocation, and outcomes of non-alcoholic fatty liver disease-related hepatocellular carcinoma: a systematic review and meta-analysis. Lancet Oncol 23, 521–530 (2022).

8. Ye, Q. et al. Global prevalence, incidence, and outcomes of non-obese or lean non-alcoholic fatty liver disease: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol 5, 739–752 (2020).

9. Huang, D. Q. et al. Metabolic dysfunction-associated steatotic liver disease in adults. Nat Rev Dis Primers 11, 14 (2025).

10. Malhotra, P., Gill, R. K., Saksena, S. & Alrefai, W. A. Disturbances in Cholesterol Homeostasis and Non-alcoholic Fatty Liver Diseases. Front Med (Lausanne) 7, 467 (2020).

11. Caballería, L. et al. High Prevalence of Liver Fibrosis Among European Adults With Unknown Liver Disease: A Population-Based Study. Clin Gastroenterol Hepatol 16, 1138-1145.e5 (2018).

12. Llop, E. et al. High liver stiffness values by transient elastography related to metabolic syndrome and harmful alcohol use in a large Spanish cohort. United European Gastroenterol J 9, 892–902 (2021).

13. Ginès, P. et al. Population screening for liver fibrosis: Toward early diagnosis and intervention for chronic liver diseases. Hepatology 75, 219–228 (2022).

14. Angulo, P. et al. Liver Fibrosis, but No Other Histologic Features, Is Associated With Long-term Outcomes of Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology 149, 389–97.e10 (2015).

15. Sanyal, A. J. Putting non-alcoholic fatty liver disease on the radar for primary care physicians: how well are we doing? BMC Med 16, 148 (2018).