Noninvasive Methods For Prediction of Esophageal Varices in Children
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2023
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJuly 18, 2023
July 1, 2023
5 months
March 12, 2023
July 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
baseline
Study Arms (1)
Laboratory investigation
Complete blood count, liver function tests, prothrombin time(PT), prothrombin concentration(PC), international normalized ratio (INR), renal chemistry and electrolytes
Interventions
size of the liver and architecture, size of the spleen, presence or absence of ascites
Eligibility Criteria
patients aged \< 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.
You may qualify if:
- patients aged \< 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71515, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emad El-Deen Mahmoud Hammad, Professor
Assiut University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Doctor
Study Record Dates
First Submitted
March 12, 2023
First Posted
March 23, 2023
Study Start
March 15, 2023
Primary Completion
August 1, 2023
Study Completion
September 1, 2023
Last Updated
July 18, 2023
Record last verified: 2023-07