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UnknownNCT06097715

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Sohag University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTupper gastrointestinal endoscopyUpper gastrointestinal endoscopy to asses present of esophageal varices and will be done to all patient group
DIAGNOSTIC_TEST1- Complete blood count 2- Coagulation profilecmplete blood count to detect thrombocytopenia, liver function test to detect if they are elevated,and any impaired coagulation profile

Timeline

Start date
2023-11-01
Primary completion
2024-10-01
Completion
2024-10-01
First posted
2023-10-24
Last updated
2023-10-24

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06097715. Inclusion in this directory is not an endorsement.