The correlation between anthropometry, metabolic profile, laboratory profile, non invasive tests and Fibroscan in MASLD- Metabolic Dysfunction Associated Steatotic Liver Disease: A real world experience
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1)To compare and correlate Non Invasive test and score – FIB 4/APRI/AST/ALT ratio /NFS with Fibroscan values – CAP /LSM
研究概览
简要总结
A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. A systemic review and meta‑analysis by Shalimar et al. showed that pooled prevalence was 38.6% in adults and pooled prevalence was 35.4% in children. De Silva S, et al, performed a retrospective study on patients with histologically confirmed NAFLD, showed that blood test-based non-invasive scores are less accurate in South Asian patients, irrespective of metabolic parameters. (population- younger, had lower body mass index) however Transient elastography was equally and highly accurate in both ethnicities. Mathew et al. - retrospective observational analytical study of patients who had a liver biopsy with a diagnosis of NAFLD, in south India- NFS of >0.676 had a sensitivity of 68% and specificity of 100%, and an FIB-4 index of >2.67 had a sensitivity of 67% and specificity of 95.6 % in diagnosing Advance fibrosis. Ornelas et al. -The total accuracy of the Fibroscan was found to be 66% (21 “good†correlation, 11 “poor†correlation). The accuracy of non-alcoholic steatohepatitis (NASH) was 91% compared to 52% for non-NASH liver diseases. Spearman rank correlation between Fibroscan and liver biopsy in NASH patients was found to be both positive and significant (Spearman’s correlation 0.699, P 0.017).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- ••Willingness to give consent and follow up •Fulfilling the criteria for MASLD •Patients with followup records available, with atleast one visit during the study period.
排除标准
- ••Cirrhosis patients •Decompensated chronic Liver disease •Pregnancy •Chronic viral hepatitis Infections •Hypotension/ shock •History of CAM intake •History of Hepatotoxic drug used in the last 3 months •Alcohol Used disorder.
结局指标
主要结局
1)To compare and correlate Non Invasive test and score – FIB 4/APRI/AST/ALT ratio /NFS with Fibroscan values – CAP /LSM
时间窗: 8 months
2)To compare and correlate anthropometry measurements with Fibroscan values – CAP /LSM
时间窗: 8 months
3)To compare the non Invasive tests- FIB 4/APRI/AST/ALT ratio /NFS and Fibroscan, pre and post treatment (after 6 months of standrard therapy).
时间窗: 8 months
次要结局
未报告次要终点
研究者
Dr Mhasisielie Zumu
Madras Medical Mission Hospital
