Noninvasive Methods For Prediction of Esophageal Varices in Children

• Conditions: Esophageal Varices
• Interventions: Diagnostic Test: Detailed abdominal ultrasound

• Registration Number: NCT05781828
• Lead Sponsor: Assiut University

Brief Summary

The aim of this study is to use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots.

Detailed Description

Portal hypertension is the underlying pathophysiological process that leads to the formation of portosystemic collaterals and heralds the onset of a severe complication: variceal hemorrhage. It is estimated that approximately 50% of pediatric patients with chronic liver disease and 90% of those with extrahepatic portal vein obstruction (EHPVO) will experience gastrointestinal bleeding.

Esophagogastroduodenoscopy (EGD) is considered the primary modality for detection and surveillance of esophageal varices (EV) and to determine the risk of bleeding. Varices were graded into four grades I, II, III, and IV according to the Modified Paquet classification. however, invasiveness of the technique and a significant risk associated with sedation on long-term neurological outcomes have limited its use.

Many studies have sought to determine clinical, laboratory, or other noninvasive methods that could predict the presence of EV. Preliminary data suggests that laboratory tests such as platelet count, albumin and ultrasonographic parameters such as presence of splenomegaly, spleen size z score and platelet count to spleen size ratio and the clinical prediction rule (CPR; calculated from platelet count, spleen size z-score, and albumin concentration) may be useful as first-line tools for identification of adults and pediatric patients at risk of variceal development and thus reduce the number of unnecessary EGDs.

Study Timeline

• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-12
• Study Start: 2023-03-15
• Study First Posted: 2023-03-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-15
• Last Update Posted: 2023-07-18
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients aged < 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.

Exclusion Criteria

• patient who underwent prior variceal treatment (any type) or variceal bleeding prophylaxis (including nonselective β-blocker use, endoscopic variceal ligation or sclerotherapy, surgical portosystemic shunt or transjugular intrahepatic portosystemic shunt insertion), liver transplantation, and malignancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laboratory investigation	Detailed abdominal ultrasound	Complete blood count, liver function tests, prothrombin time(PT), prothrombin concentration(PC), international normalized ratio (INR), renal chemistry and electrolytes

Primary Outcome Measures

Name	Time	Method
noninvasive methods for prediction of esophageal varices in children compared to esophagogastroduodenoscopy results	baseline	use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt