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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06097715
Collaborator
(none)
30
1
2
11
2.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: upper gastrointestinal endoscopy
  • Diagnostic Test: 1- Complete blood count 2- Coagulation profile
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical, Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: patient group

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

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

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

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with early detection of portal hypertension in patient with chronic liver diseases [1 year]

    we aim to early of portal hypertension in patient with chronic liver diseases before occurance of complications as esophageal bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sara Mohamed Abuelfadl, specialist of pediatrics at sohag teaching hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT06097715
Other Study ID Numbers:
  • Soh-Med-23-10-02MD
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023