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

NCT ID: NCT06097715

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-10-31

Brief 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

Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient group

patients which previosly diagnosed with chronic liver diseases or presented with manifestations of chronic liver diseases

Group Type: ACTIVE_COMPARATOR

upper gastrointestinal endoscopy

Intervention Type: DIAGNOSTIC_TEST

Upper gastrointestinal endoscopy to asses present of esophageal varices and will be done to all patient group

1- Complete blood count 2- Coagulation profile

Intervention Type: DIAGNOSTIC_TEST

cmplete blood count to detect thrombocytopenia, liver function test to detect if they are elevated,and any impaired coagulation profile

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.

Group Type: ACTIVE_COMPARATOR

1- Complete blood count 2- Coagulation profile

Intervention Type: DIAGNOSTIC_TEST

cmplete blood count to detect thrombocytopenia, liver function test to detect if they are elevated,and any impaired coagulation profile

Interventions

upper gastrointestinal endoscopy

Upper gastrointestinal endoscopy to asses present of esophageal varices and will be done to all patient group

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mohamed Abuelfadl

specialist of pediatrics at sohag teaching hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

Sarah M Abo El Fadl, spcialist

Role: CONTACT

sara_abuelfadl_post@med.sohag.edu.eg

01061264464

Mohamed M Fawaz, professor

Role: CONTACT

01202595072

Facility Contacts

Magdy M Amin, professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 29287004 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36292062 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34021479 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33544313 (View on PubMed)

Other Identifiers

Soh-Med-23-10-02MD

Identifier Type: -

Identifier Source: org_study_id