Diagnostic Accuracy of Spleen and Liver Stiffness Measurement by EUS-elastography, to Predict Portal Hypertension in Patients With Cirrhosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- evaluate the accuracy of LSM and SSM by EUS-elastography (EUS-E) to assess PH in patients with liver cirrhosis and determinate if EUS-E can be used as a surrogate marker for PH. It also aims to find the optimal liver and spleen EUS-E values in predicting
研究概览
简要总结
Patients with cirrhosis have structural and functional alterations of the liver. The progressive deposition of hepatic fibrosis is related to the subsequent development of portal hypertension (PH), and PH is associated with mayor complications including ascites, hepatic encephalopathy and development of gastroesophageal varices with a high risk of bleeding. Variceal bleeding is a medical emergency associated with a 6-week mortality rate of approximately 10-20%. Liver biopsy is the gold standard for the assessment of hepatic fibrosis, whereas the measurement of hepatic vein pressure gradient (HVPG) is the standard to evaluate PH and upper endoscopy (UE) is the method of choice to detect the presence and grade of gastroesophageal varices. The last two also estimates the risk of variceal bleeding. Unfortunately, clinical investigation of PH implies HVPG measurement or endoscopy for esophageal varices (EV) screening and grading. The first one is an invasive technique, mainly restricted to tertiary centers, that requires personal training, increased health care costs and patient discomfort. The UE, even though has demonstrated utility to predict HVPG (HVPG value ≥ 10 mmHg predicts the presence of EV and a value ≥ 12 mmHg is predictive for variceal bleeding), has been criticized of being subjective. Because of this, alternative test including elastographic techniques, have been develop to assess the severity of PH, the presence of EVs and the risk of variceal bleeding. Elastography is a technique used to measure tissue elasticity and stiffness in real time, by the application of slight compression using a transducer to the targeted tissue. The principle is that tissue compression produces deformation (strain) and that the strain is smaller in harder tissue as compared to softer tissue. Consequently, by measuring the tissue strain induced by compression, it is possible to estimate the tissue hardness. Fibroscan® (FS) (Echosens, París, Francia) uses the principle of one-dimension transient elastography (TE) for the assessment of tissue stiffness. It was used initially for liver stiffness measurement (LSM) and proved to be reliable for the diagnosis of liver cirrhosis and avoid liver biopsy in 90% of cases. Also LSM by TE accurately correlates with the severity of PH and the presence of esophageal varices.
详细描述
More recently, the use of Fibroscan for the spleen stiffness measurement (SSM) has become particularly attractive to assess. Previous studies have demonstrated that liver cirrhosis and PH generates some modifications in the spleen such as an increment in size, splenic blood flow, tissue hyperplasia, and fibrosis that determine an increase in the spleen's density and tissue stiffness that may be quantified by elastography. The SSM was found to be a valuable tool for assessing the degree of PH, the presence and severity of EVs and the risk of variceal bleeding among patients with cirrhosis. Moreover, spleen stiffness as compared with liver stiffness better represents the dynamic changes occurring in the advanced stages of cirrhosis and shows higher diagnostic performance in detecting esophageal varices.
Elastography can also be applied by endoscopic ultrasound (EUS-E). The EUS elastography allowed qualitative and quantitative evaluation. Qualitative elastography evaluates tissue elasticity by measuring the degree of deformation using a scale in the B-mode image of 1 to 255. This scale is represented by a color map (red- green-blue), wherein hard tissue is shown in dark blue, tissue with intermediate hardness in green, medium soft tissue in yellow, and soft tissue in red. There are two options for quantitative elastography and both are based on the qualitative EUS elastography data, the hue histogram and strain ratio. The hue histogram represents the overall elasticity within a manually selected area witch is the region of interest (ROI). The global hardness is being represent by a hue scale from 0 to 250, where 0 represents the hardest and 255 is the softest. The strain ratio (SR) analyzes the elastographic picture of the target lesion in relation to the surrounding tissues. Two different areas (A and B) are selected. Area A includes as much of the target lesion as possible without including the surrounding tissues. Area B is selected within a soft (red) reference area outside the target lesion, preferably the gut wall. The strain ratio is calculated as the quotient of B/A.
EUS is also a technique that has proved to be useful to evaluate cirrhotic patients in many aspects. It allows visualization of a greater part of the portal and portosystemic collateral circulation. It can be used to detect esophageal and gastric varices witch correlate with the presence and severity of liver disease and portal hypertension. It can be use to measure varices size. Large varices (≥ 5 mm) may be risk factors for variceal hemorrhage. It can visualize paramural collaterals and large vessels such as splenic, portal and azygos veins. Previous studies have found a significant increase in azygos vein diameter and blood-flow velocity in patients with varices when compared with control subjects. The evaluation of the azygos vein using EUS can ad useful information about the porto-systemic collateral circulation and could help to determine the treatment efficacy. It has been found a decrease in the azygos vein flow following terlipressin and somatostatin administration, band ligation or sclerotherapy in patients with portal hypertension. EUS can predict variceal recurrence after endoscopic therapy. Finally, cirrhosis causes dilation thoracic duct and thickening of gastric mucosa and submucosa that can be determinate by EUS.
MATERIAL AND METHODS
Study design: This is a prospective, observational, non-randomized and simple blind study, performed in a Tertiary Academic Center.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 - 80 years old.
- •Who agree to participate in the study.
- •Compensated liver cirrhotic patients (alcohol, virus, autoimmune, NASH, primary sclerosing cholangitis and primary biliary cirrhosis).
排除标准
- •Moderate or severe perihepatic or perisplenic ascites. The presence of ascites limits the stiffness measurement.
- •Acute and acute on chronic hepatitis. It aims to decrease the influence of inflammation in the elastography evaluation.
- •Multiple focal liver lesions.
- •Cholestatic liver disease and biliary obstruction.
- •Failure to carry out liver TE by Fibroscan. Patients with an interquartile range (IQR) >30% of the median value and a success rate <60% will be excluded from the analysis but included in the intention to treat.
- •Portal vein thrombosis.
- •Esophageal, gastric, liver, spleen or pancreatic tumors that may impede to perform a correct EUS-E
- •Cirrhotic patients with a recent episode of gastrointestinal bleeding or infection that may affect the hemodynamic flow.
- •Splenectomy or history of partial splenic embolization.
- •Pregnancy.
- •Patient' s refusal to participate in this study.
结局指标
主要结局
evaluate the accuracy of LSM and SSM by EUS-elastography (EUS-E) to assess PH in patients with liver cirrhosis and determinate if EUS-E can be used as a surrogate marker for PH. It also aims to find the optimal liver and spleen EUS-E values in predicting
时间窗: 4 month
The diagnostic performance of LSM and SSM by EUS elastography will be assessed using sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV), accuracy, likelihood ratio (LR), Odds ratios (OR) with a 95% confidence intervals (CI) and receiver-operating characteristic (ROC) curves.
次要结局
- correlation between LSM and SSM by EUS-E and hemodynamic changes in the porto-systemic collateral circulation measure by an increase in azygos vein diameter and blood-flow velocity.(4 month)
- correlation between LSM, using transient elastography (Fibroscan) and EUS-E.(4 month)