Methods to improve the noninvasive diagnosis and assessment of disease severity in children with suspected nonalcoholic fatty liver disease (NAFLD): Study design
| Autor: | Nadia Ovchinsky, Bryan Rudolph, Howard D. Strickler, Adriana Perez, Mark C. Liszewski, Shankar Viswanathan, Michelle Ewart, Debora Kogan-Liberman, Xiaonan Xue, Qiang Liu, Nicole L. Bjorklund, Terry L. Levin |
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| Rok vydání: | 2018 |
| Předmět: |
Male
Pediatric Obesity medicine.medical_specialty Adolescent Biopsy Overweight Severity of Illness Index Asymptomatic Article 03 medical and health sciences Liver disease 0302 clinical medicine Non-alcoholic Fatty Liver Disease Internal medicine Nonalcoholic fatty liver disease medicine Humans Pharmacology (medical) Child Ultrasonography medicine.diagnostic_test business.industry Alanine Transaminase General Medicine Gold standard (test) medicine.disease Work-up Cross-Sectional Studies Liver Child Preschool 030220 oncology & carcinogenesis Liver biopsy Elasticity Imaging Techniques Female 030211 gastroenterology & hepatology medicine.symptom business Biomarkers |
| Zdroj: | Contemporary Clinical Trials. 75:51-58 |
| ISSN: | 1551-7144 |
| DOI: | 10.1016/j.cct.2018.10.012 |
| Popis: | Background Nonalcoholic fatty liver disease (NAFLD) is strongly associated with obesity and is the most common liver disease in the developed world. In children with suspected NAFLD, present guidelines suggest consideration of alternative diagnoses via extensive blood testing, though the yield of this work up is unknown. Furthermore, the gold standard diagnostic test for NAFLD remains liver biopsy, making the development of non-invasive tests critically important. Objectives Our objectives are: 1) to determine the accuracy of elastography and multiple serum biomarkers – each assessed individually and as algorithms (including those previously tested in adults) – for the diagnosis of nonalcoholic steatohepatitis (NASH) and early fibrosis in children and (2) to examine the utility of extensive testing for rare alternative diagnoses in overweight or obese children with elevated alanine aminotransferase (ALT) suspected to have NAFLD. Design This is an ongoing, cross-sectional study in children 2–18 years of age with up to 2 years of prospective follow up. Eligible patients are asymptomatic, overweight or obese, and have an ALT ≥35 U/L upon enrollment. Two forms of elastography are obtained serially along with anthropometric data and routine laboratory tests. Elastography and serum biomarkers are also performed immediately prior to any clinically-indicated biopsy. Methods Between April 2015 and April 2018, 193 children have been enrolled in this ongoing study and 71 have undergone liver biopsy. Here we carefully report the rationale, methodology, and preliminary data for this study. |
| Databáze: | OpenAIRE |
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