Clinical, Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with early detection of portal hypertension in patient with chronic liver diseases
研究概览
简要总结
Portal hypertension is a significant cause of morbidity and mortality in children with chronic liver disease and portal vein obstruction. It results in severe complications such as ascites, hepatic encephalopathy and gastrointestinal variceal bleeding. (Sutton et. al., 2018).
Esophageal varices is an important manifestation of portal hypertension that develops over time in children with chronic liver disease. The risk of esophageal varices hemorrhage increases depending on the underlying disease as well as the duration of the disease and the mortality rate as high as 5% - 20 % during patient follow up. Invasive procedures such as gastroscopy are performed repeatedly to detect the presence and progression of esophageal varices. Many non-invasive methods have been investigated to their efficacy in determining the presence of esophageal varices and the risk of complications in the presence of portal hypertension. (Taşkın et.al., 2023).
Early diagnosis of portal hypertension is often difficult as it can be asymptomatic. During this stage, the patient may feel nothing except for mild fatigue or abdominal discomfort and therefore, patients mostly go undiagnosed (Hartl et.al., 2021). (Selicean et.al., 2021). However, it is worth noting that some of the results from medical investigation may be abnormal during this stage. These include abnormal liver function, abnormal routine blood examination (thrombocytopenia), and changes in the stiffness of the liver which can be found during ultrasound despite the patient being asymptomatic. ( Mohanty et al., 2021).
Though the gold standard to diagnose portal hypertension is hepatic venous pressure gradient (HVPG) and a value more than 10 mmHg defines clinically significant portal hypertension (CSPH) ( Man Zhang et.al., 2022). Since HVPG measurement is scarcely available and invasive, several non-invasive tests are used as surrogate markers of CSPH. Amongst them, elastography techniques measuring liver stiffness (LS) and spleen stiffness (SS) are the extensively studied ones which can be done by elastography machines that can be attached to conventional ultrasound (USG) machines . Amongst them, 2D-shear wave elastography (2D-SWE) is the most recent one, and it assesses stiffness and related parameters by tracking shear waves propagated through a media. (Sattanathan et.al., 2023).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 1- Age: < 18 years 2- Manifestations of hepatic disease like jaundice, hepatic encephalopathy, organomegally.
- •3- Children previously diagnosed with chronic liver disease
排除标准
- •1- Age: > 18 years. 2- Non compliant child during technique of elastography. 3- Patient with ascites. 4- Patient with portosystemic shunt surgery
研究组 & 干预措施
patient group
patients which previosly diagnosed with chronic liver diseases or presented with manifestations of chronic liver diseases
干预措施: upper gastrointestinal endoscopy (Diagnostic Test)
patient group
patients which previosly diagnosed with chronic liver diseases or presented with manifestations of chronic liver diseases
干预措施: 1- Complete blood count 2- Coagulation profile (Diagnostic Test)
control group
children in the same age and sex of the patient group and presented to Sohag Universty Hospital due to any complaint rather than hepatic and gastrointestinal disease.
干预措施: 1- Complete blood count 2- Coagulation profile (Diagnostic Test)
结局指标
主要结局
Number of participants with early detection of portal hypertension in patient with chronic liver diseases
时间窗: 1 year
we aim to early of portal hypertension in patient with chronic liver diseases before occurance of complications as esophageal bleeding
次要结局
未报告次要终点
研究者
Sara Mohamed Abuelfadl
specialist of pediatrics at sohag teaching hospital
Sohag University
