Non-invasive Predictors of Esophageal Varices and Their Correlation to Upper Endoscopic Findings
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged less than 18 years diagnosed with portal hypertension either due to hepatic or extrahepatic causes
Disqualifiers
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).
Trial 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)
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
Correlation between non-invasive markers and endoscopic grade of esophageal varices in children with portal hypertension
The relationship between non-invasive markers (platelet count, spleen size z-score, platelet-to-spleen size ratio, CPR, APRI, FIB-4 score, and King score) and the endoscopic grade of esophageal varices (Grade I-III) will be analyzed using Spearman correlation analysis to determine the strength of association between marker values and variceal grade.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: