Clinical,Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases

Study Overview
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Brief Summary
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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).

Official Title
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Clinical, Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases

Conditions
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Portal Hypertension

Intervention / Treatment
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* Diagnostic Test: upper gastrointestinal endoscopy
* Diagnostic Test: 1- Complete blood count 2- Coagulation profile


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1- Age: < 18 years 2- Manifestations of hepatic disease like jaundice, hepatic encephalopathy, organomegally. 3- Children previously diagnosed with chronic liver disease Exclusion Criteria: 1- Age: > 18 years. 2- Non compliant child during technique of elastography. 3- Patient with ascites. 4- Patient with portosystemic shunt surgery

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patient group<br>patients which previosly diagnosed with chronic liver diseases or presented with manifestations of chronic liver diseases | Diagnostic Test: upper gastrointestinal endoscopy<br>* Upper gastrointestinal endoscopy to asses present of esophageal varices and will be done to all patient group<br>Diagnostic Test: 1- Complete blood count 2- Coagulation profile<br>* cmplete blood count to detect thrombocytopenia, liver function test to detect if they are elevated,and any impaired coagulation profile<br>|
| Active Comparator: control group<br>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. | Diagnostic Test: 1- Complete blood count 2- Coagulation profile<br>* cmplete blood count to detect thrombocytopenia, liver function test to detect if they are elevated,and any impaired coagulation profile<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with early detection of portal hypertension in patient with chronic liver diseases | we aim to early of portal hypertension in patient with chronic liver diseases before occurance of complications as esophageal bleeding | 1 year |