Clinical trial NCT05781828: Noninvasive Methods For Prediction of Esophageal Varices in Children
Official title: Noninvasive Methods For Prediction of Esophageal Varices in Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Esophageal Varices
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged \< 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: noninvasive methods for prediction of esophageal varices in children compared to esophagogastroduodenoscopy results
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Emad El-Deen Mahmoud Hammad, Professor
role: STUDY_DIRECTOR
References: