An observational study in Esophageal Varices, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Assiut University · Observational
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.
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.
171 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.
This study's planned enrollment of 30 is below the median of 130 across 52 observational studies indexed under Esophageal and Gastric Varices.
Browse Esophageal and Gastric Varices studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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patients aged \< 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.
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Exclusion Criteria:
Complete blood count, liver function tests, prothrombin time(PT), prothrombin concentration(PC), international normalized ratio (INR), renal chemistry and electrolytes
Diagnostic Test: Detailed abdominal ultrasound
size of the liver and architecture, size of the spleen, presence or absence of ascites
noninvasive methods for prediction of esophageal varices in children compared to esophagogastroduodenoscopy results
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.
Time frame: baseline
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Esophageal and Gastric Varices →