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Noninvasive Methods For Prediction of Esophageal Varices in Children

Noninvasive Methods For Prediction of Esophageal Varices in Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05781828
Enrollment
30
Registered
2023-03-23
Start date
2023-03-15
Completion date
2023-09-01
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Varices

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.

Interventions

DIAGNOSTIC_TESTDetailed abdominal ultrasound

size of the liver and architecture, size of the spleen, presence or absence of ascites

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
noninvasive methods for prediction of esophageal varices in children compared to esophagogastroduodenoscopy resultsbaselineuse 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026