儿童和青少年非酒精性脂肪性肝病的临床流行病学。LiverKids：研究方案。
Clinical epidemiology of non-alcoholic fatty liver disease in children and adolescents. The LiverKids: Study protocol.
机构信息
Unitat de Suport a la Recerca Metropolitana Nord (USR Metro-Nord), Institut Universitari d'Investigació en Atenció Primària Jordi Gol i Gurina (IDIAP Jordi Gol), Mataró, Barcelona, Spain.
Grup de Recerca en Malalties Hepàtiques a l'Atenció Primària (GRemHAp), IDIAP Jordi Gol, USR Metro-Nord, Mataró, Barcelona, Spain.
出版信息
PLoS One. 2023 Oct 13;18(10):e0286586. doi: 10.1371/journal.pone.0286586. eCollection 2023.
BACKGROUND
Non-alcoholic fatty liver disease (NAFLD) is rapidly increasing alongside overweight and obesity, not only in adults but also in children and adolescents. It is unknown what impact the development of NAFLD in childhood may have in later life. The importance of early detection and treatment lies in its potential for progression to cirrhosis, liver cancer and liver-related death, as well as its associated extrahepatic comorbidities. Vibration-Controlled Transient Elastography (VCTE) with Controlled Attenuation Parameter (CAP) is an effective, non-invasive and safe diagnostic method to estimate the degree of fibrosis and steatosis in the liver, but little is known about its applicability in the paediatric population.
AIMS
- To assess the prevalence of significant liver fibrosis (Liver Stiffness Measurement (LSM) ≥6.5 kPa) using VCTE, and that of non-alcoholic fatty liver disease (≥225 dB/m) using CAP in children and adolescents. 2) To determine the optimal cut-off points of the CAP to achieve maximum concordance with the Magnetic Resonance Imaging (MRI) findings in the diagnosis of mild, moderate and severe NAFLD in children and adolescents.
METHODS
Cross-sectional population-based study which will include 2,866 subjects aged between 9 and 16 years. Participants will undergo: anamnesis, physical examination, blood extraction, VCTE, MRI and questionnaires on socio-demographic data, personal and family medical history and lifestyle assessment.
APPLICABILITY AND RELEVANCE
The study aims to establish the foundations for the use of VCTE in children and adolescents in order to achieve early diagnosis of NAFLD. Moreover, it will serve to understand in further detail the disease and to identify the risk groups of children and adolescents who may be at risk of developing it. Ultimately, this will help determine to which subgroups of the population we need to target resources for prevention and early detection of this entity, as well as possible intervention for its treatment.
TRIAL REGISTRATION
The LiverKids study is registered on Clinicaltrials.gov (NCT05526274).
背景
非酒精性脂肪性肝病（NAFLD）随着超重和肥胖的增加而迅速增加，不仅在成年人中，而且在儿童和青少年中也是如此。目前尚不清楚儿童期 NAFLD 的发展可能会对以后的生活产生什么影响。早期发现和治疗的重要性在于其向肝硬化、肝癌和与肝脏相关的死亡进展的潜力，以及其相关的肝外合并症。振动控制瞬态弹性成像（VCTE）与受控衰减参数（CAP）是一种有效的、非侵入性和安全的诊断方法，可用于评估肝脏纤维化和脂肪变性的程度，但对于其在儿科人群中的适用性知之甚少。
目的
1）使用 VCTE 评估儿童和青少年中显著肝纤维化（肝脏硬度测量（LSM）≥6.5kPa）的患病率，以及使用 CAP 评估非酒精性脂肪性肝病（≥225dB/m）的患病率。2）确定 CAP 的最佳截断值，以在儿童和青少年中实现与磁共振成像（MRI）诊断轻度、中度和重度 NAFLD 的最大一致性。
方法
一项基于人群的横断面研究，将包括 2866 名 9 至 16 岁的受试者。参与者将接受以下检查：病史、体格检查、血液提取、VCTE、MRI 和关于社会人口统计学数据、个人和家族病史以及生活方式评估的问卷调查。
适用性和相关性
本研究旨在为儿童和青少年使用 VCTE 奠定基础，以实现 NAFLD 的早期诊断。此外，它将有助于更详细地了解该疾病，并确定可能患有该疾病的儿童和青少年的风险群体。最终，这将有助于确定我们需要针对该人群的哪些亚组进行资源分配，以预防和早期发现该实体，并对其治疗进行可能的干预。
试验注册
LiverKids 研究在 Clinicaltrials.gov 上注册（NCT05526274）。
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