New blood test could do away with invasive liver biopsy in NAFLD patients

Non-alcoholic fatty liver disease (NAFLD) is the most common pediatric liver disorder that affects about 1 in 10 children. It can lead to cirrhosis, liver failure, and liver cancer. Yet, the natural history NAFLD is poorly understood and there are currently no approved treatments or drugs in clinical trials for children.

Now, a team of European researchers have developed a new blood test that could do away with the need for liver biopsy in the management of paediatric NAFLD. The blood test would soon be implemented in clinical practice within five years. Currently, if a doctor is concerned a child has scarring or inflammation of the liver they may recommend a liver biopsy.

The results were presented by the researchers at the 52nd Annual Meeting of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) held in Glasgow, Scotland.

The study analyzed 67 children (mean age 10.6 years) with NAFLD diagnosed by liver biopsy, including two-thirds with non-alcoholic steatohepatitis (NASH). Children with NASH were older (8.6 vs 11.4 years), but no other baseline anthropometric or biochemistry measurement differentiated steatosis from NASH.

They found that different types of fats in the blood were associated with features of fatty liver on liver biopsy and correlated with the presence of fibrosis and NASH.

They studied 67 children (mean age 10.6 years) with NAFLD diagnosed by liver biopsy, including two-thirds with non-alcoholic steatohepatitis (NASH). Children with NASH were older (8.6 vs 11.4 years), but no other baseline anthropometric or biochemistry measurement differentiated steatosis from NASH.

Liver biopsy is currently the most accurate test for NAFLD and the only method routinely used in practice for assessing the presence of scarring or inflammation. However, the biopsy is invasive, resource intensive, costly, prone to sampling error and carries a small risk of significant complications. Therefore, the availability of an accurate and non-invasive marker to replace the need for liver biopsy, both in routine practice and in a clinical trial setting, is a major breakthrough for children, parents and healthcare professionals.

The study by Jake Mann, Wellcome Trust Clinical Research Fellow at the Institute of Metabolic Science, University of Cambridge, and colleagues is the first major finding to be reported from the European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNALFD registry), an international collaboration of 11 specialist and non-specialist centres in six European countries. When fully operational, the registry will have enrolled up to 2,000 children, including 500 with biopsy-proven pediatric NAFLD, and follow-up will continue for up to 30 years.

"It is early days but the results of the research are promising and could help shift the way we understand and manage paediatric NAFLD: saving resources, time, and stress for children and their parents," Dr Mann said in a news release.

"The EU-PNAFLD registry will facilitate recruitment into interventional clinical trials as well as imaging, biomarker, and translational studies, plus allow greater understanding of the long-term natural history of NAFLD. The ultimate aim is to understand the condition sufficiently to intervene and slow disease progression so we can reduce the number of patients requiring liver transplantation later in life," Dr Mann said in the release.

"It is great to hear that the registry, supported through CLDF research funds, is already yielding such fantastic insights to improve the diagnosis and care of children affected by NAFLD," Alison Taylor, Chief Executive of the Children's Liver Disease Foundation (CLDF), commented in the release. "In particular, it is wonderful to see such progression in the development of non-invasive tests which will positively impact children, young people and their families at a time that is incredibly stressful. We know that further significant developments in care will come via the EU-PNALFD registry and we are proud to be supporting the initiative."