The Accuracy of MAFLD Fibrosis Score in Detecting Fibrotic NASH in MAFLD Egyptian Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Accuracy of MFS in detecting Fibrotic NASH
研究概览
简要总结
Metabolic-associated fatty liver disease (MAFLD), is a metabolic stress-induced liver injury characterized by diffuse hepatocyte macrovesicular fatty infiltration.
The incidence of MAFLD is increasing yearly, and its incidence rate is as high as 20% to 30% on a global scale, which seriously affects people's health. Non-alcoholic steatohepatitis (NASH), a chronic hepatitis that can progress to advanced fibrosis, decompensated cirrhosis, and hepatocellular carcinoma, affects one-fifth of NAFLD patients. Depending on the histological severity of fibrosis, patients with NASH can be further classified as early NASH (F0-F1 fibrosis), fibrotic NASH (≥F2 fibrosis), or NASH-cirrhosis (F4 fibrosis).
Identifying subjects with fibrotic NASH is essential as they are at risk of complications, and disease progression and may benefit from potential pharmacological therapy.
Assessment of fibrotic NASH ranges from noninvasive scores to percutaneous liver biopsy, but liver biopsy is invasive and limited by cost, sampling variability, and intrareader/interreader variability.
Noninvasive modalities to risk stratify fibrotic NASH include serum biomarkers, imaging, and algorithms combining both. The FibroScan-AST (FAST) composite score is based on the liver stiffness measure (LSM), controlled attenuation potential (CAP), and AST. At the cut-off of a FAST score ≥0.67, biopsy-proven fibrotic NASH (NAFLD with a histological NAFLD activity score [NAS] ≥4 and fibrosis ≥2) can be ruled in with 90% specificity.
A new predictive model was recently developed based on eight variables (age, BMI, HbA1c, history of type 2 diabetes, International normalized ratio (INR), AST, Gamma Glutamyl transferase (GGT), and platelet count). A composite score MAFLD Fibrosis Score (MFS) was calculated as: MFS = 0.078 × Age (year)-0.007363 × Platelet count (109/L) + 0.0146 × AST (U/L) + 0.007618 × GGT (U/L) + 6.673 × INR + 0.09833 × BMI (kg/m2) + 1.425 × type 2 diabetes (yes = 1, no = 0).
So, in this study, the investigators will try to evaluate the accuracy of the new emerging predictor MAFLD Fibrosis Score (MFS) vs AST- to-platelet ratio index (APRI) score, fibrosis-4 index (FIB-4) score, and NAFLD fibrosis score in the assessment of the fibrotic NASH in Egyptian NAFLD patients.
详细描述
This study will be a cross-sectional study and will be carried out on 380 MAFLD patients attending to Tanta tropical medicine outpatient clinic, faculty of medicine. The start of the research will be in March 2024 to August 2024 or until collecting the cases.
Sample size The study will be carried on 382 patients according to the prevalence in Egypt 47.5% with confidence level 95% and margin of error 5 All the patients will be subjected to;
History taking:
Full history taking including:
- Personal history (name, age, sex, occupation, residence and marital state).
- Anthropometric measures: weight, length, BMI, Waist circumference.
- Complaint.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients older than 18 years.
- •NAFLD Patients assessed by ultrasound, fibroscan.
排除标准
- •Patients aged < 18 years
- •pregnant women.
- •Excess alcohol intake (more than 30 g in men and 20 g in women).
- •Viral hepatitis.
- •Autoimmune hepatitis
- •secondary fatty liver (e.g., the use of systemic steroids or methotrexate).
- •history of malignancy in the past 2 years.
- •Unwilling to participate in our study.
结局指标
主要结局
Accuracy of MFS in detecting Fibrotic NASH
时间窗: till August 2024
evaluation of accuracy of MAFLD Fibrosis Score (MFS) in the assessment of the fibrotic NASH in Egyptian patients.
次要结局
未报告次要终点
研究者
Rania Mamdouh Elkafoury
Principle Investigator
Tanta University