Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan
研究概览
简要总结
This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.
详细描述
This is a prospective longitudinal study that will evaluate the utility of change in liver stiffness (LSM) and spleen stiffness measurements after a test meal in patients whom the diagnosis cannot be reliably ruled in or ruled out based on two measurement of LSM by TE per standard of care. This includes patients in whom there is discordance between clinical impression and LSM and/or LSM are in the grey zone (LSM between 10 and 15 kPa). Liver biopsy/HVPG which is performed as standard of care will be used as gold standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
All the above, the patient, provider and investigator and outcome assessor will not know the result of the biopsy to know if the participant does or does not have cirrhosis at the time of the study
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85
- •History of chronic liver disease who have had a liver stiffness measurement performed that is discordant with clinical impression (clinically the patient appears to have cirrhosis but LSM <10) or clinically there is no evidence of cirrhosis but LSM>15) or LSM are in the grey zone (LSM between 10 and 15 kPa)
排除标准
- •Any signs of decompensated cirrhosis (e.g., jaundice, ascites, variceal hemorrhage, or hepatic encephalopathy)
- •Hepatocellular carcinoma
- •Patients with chronic Hep C who have undergone antiviral therapy
- •Ongoing alcohol abuse
- •Acute hepatitis
- •Pregnancy
研究组 & 干预措施
Chronic liver disease
patient who will undergo liver biopsy will undergo liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
干预措施: Fibroscan and Acoustic Radiation Force Impulse (Device)
Chronic liver disease
patient who will undergo liver biopsy will undergo liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
干预措施: Fibroscan (Device)
Chronic liver disease
patient who will undergo liver biopsy will undergo liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
干预措施: Acoustic Radiation Force Impulse (Device)
结局指标
主要结局
Change in liver and spleen stiffness from pre and post meal obtained by Fibroscan
时间窗: 30 minutes interval between the two measurements of liver stiffness from pre meal to post meal
Liver stiffness will be obtained by fibroscan in kPa, Liver stiffness will be obtained pre and post meal, the delta change of liver stiffness will be computed in an AUROC to see the Sensitivity, specificity, positive predictive value and negative predictive value of the delta change and diagnosing or excluding cirrhosis
次要结局
- Change in liver and spleen stiffness from pre and post meal obtained by ARFI(30 minutes interval between the two measurements of liver and spleen stiffness from pre meal to post meal)