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

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06097715
• Other study ID #: Soh-Med-23-10-02MD
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Sohag University
• Contact: Sarah M Abo El Fadl, spcialist
• Phone: 01061264464
• Email: sara_abuelfadl_post[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Diseases
• Portal Hypertension

Intervention

Diagnostic Test:
• upper gastrointestinal endoscopy
Upper gastrointestinal endoscopy to asses present of esophageal varices and will be done to all patient group
• 1- Complete blood count 2- Coagulation profile
cmplete blood count to detect thrombocytopenia, liver function test to detect if they are elevated,and any impaired coagulation profile

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Hartl L, Jachs M, Desbalmes C, Schaufler D, Simbrunner B, Paternostro R, Schwabl P, Bauer DJM, Semmler G, Scheiner B, Bucsics T, Eigenbauer E, Marculescu R, Szekeres T, Peck-Radosavljevic M, Kastl S, Trauner M, Mandorfer M, Reiberger T. The differential activation of cardiovascular hormones across distinct stages of portal hypertension predicts clinical outcomes. Hepatol Int. 2021 Oct;15(5):1160-1173. doi: 10.1007/s12072-021-10203-9. Epub 2021 May 21. — View Citation

Selicean S, Wang C, Guixe-Muntet S, Stefanescu H, Kawada N, Gracia-Sancho J. Regression of portal hypertension: underlying mechanisms and therapeutic strategies. Hepatol Int. 2021 Feb;15(1):36-50. doi: 10.1007/s12072-021-10135-4. Epub 2021 Feb 5. — View Citation

Sutton H, Dhawan A, Grammatikopoulos T. Non-invasive Markers of Portal Hypertension: Appraisal of Adult Experience and Potential Utilisation in Children. J Pediatr Gastroenterol Nutr. 2018 Apr;66(4):559-569. doi: 10.1097/MPG.0000000000001882. — View Citation

Zhang M, Jin H, Cao J, Ren R, Jia M, Yang Y, Li X, Chen M, Li S, Huang L, Ling W. Application of Ultrasound Elastography in Assessing Portal Hypertension. Diagnostics (Basel). 2022 Sep 29;12(10):2373. doi: 10.3390/diagnostics12102373. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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