Non-invasive Predictors of Esophageal Varices and Their Correlation to Upper Endoscopic Findings

NCT07464522 | Not Yet Recruiting DMC

• 1 other identifier: Non-invasive predictors of O.V
• Study Type: observational
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study:

• To evaluate the diagnostic accuracy of non-invasive markers in predicting the presence and grading of esophageal varices in children with portal hypertension.
• To correlate these non-invasive markers with the severity of portal hypertension and the grade of esophageal varices to identify patients at high risk of bleeding.
• To propose a defined protocol for screening esophageal varices in those children.

Conditions

Esophageal Varices; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Area Under the Receiver Operating Characteristic (AUROC) Curve of non-invasive markers for predicting esophageal varices in children with portal hypertension

  The AUROC will be used as the aggregate reported value to represent the diagnostic performance of the following markers: platelet count, spleen size z-score, platelet-to-spleen ratio, AST-to-Platelet Ratio Index (APRI), FIB-4 score, and King score. Using the AUROC combines sensitivity and specificity across all possible cut-off values into a single statistical measure of diagnostic accuracy for predicting the presence and grade of esophageal varices. Esophagogastroduodenoscopy (EGD) will serve as the reference (gold standard) method for detecting and grading esophageal varices.

  Baseline

Secondary Outcomes (1)

• Correlation between non-invasive markers and endoscopic grade of esophageal varices in children with portal hypertension

  Baseline

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Portal hypertension in children will be defined using non-invasive clinical, laboratory, and Doppler-ultrasound criteria, in the context of clinical presentation, without invasive pressure measurements. Patients with portal hypertension will be classified as: patients with hepatic causes and patients with extrahepatic causes All patients included in this study will be subjected to: * 1\. Full Clinical History * 2\. Detailed Clinical Examination * 3\. Laboratory Investigations * 4\. Abdominal Ultrasound * 5\. Doppler Ultrasound * 6.Non-invasive predictive scores for esophageal varices The following parameters will be assessed: * Platelet count (PLT) * Spleen size z-score * Platelet count to spleen size ratio: * CPR (Calculated Platelet Ratio) * APRI (AST to Platelet Ratio Index) * FIB-4 * King score * MELD and PELD scores will be analyzed as secondary variables and not as primary predictors of esophageal varices -7. Esophagogastroduodenoscopy (EGD)

You may qualify if:

• Patients aged less than 18 years diagnosed with portal hypertension either due to hepatic or extrahepatic causes

You may not qualify if:

• Active variceal bleeding at presentation (hemodynamic instability affects platelet/spleen parameters).
• Previous history of variceal bleeding or endoscopic intervention (band ligation/sclerotherapy).
• Prior surgical portosystemic shunts or Transjugular Intrahepatic Portosystemic Shunt (TIPS).
• Current use of vasoactive drugs for primary prophylaxis (e.g., Non-selective beta-blockers).
• Systemic infections or hematological disorders causing independent thrombocytopenia or splenomegaly (to avoid confounding the platelet/spleen ratio).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Esophageal and Gastric Varices; Hypertension, Portal

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases

Central Study Contacts

Mennat-Allah H Abdelraheem, MD

CONTACT

+201061811080; menna128hesham1712@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatrics

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 11, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): May 20, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share