Ultrasound Prediction of Esophageal Variceal Bleeding Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Variceal Bleeding, Ultrasonography, Esophageal Bleeding, Esophageal Varices. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Splenic Size and Portal Vein Diameter on Ultrasound in Predicting Esophageal Variceal Bleeding Risk
Overview
This prospective observational study aims to evaluate the accuracy of using routine abdominal ultrasound to predict the risk of esophageal variceal bleeding in adult patients with liver cirrhosis. Esophageal variceal bleeding is a serious complication of chronic liver disease. While upper gastrointestinal endoscopy is the current standard for diagnosing and grading these varices, it is an invasive procedure. In this study, researchers will use ultrasound to measure the patient's spleen size and portal vein diameter. These non-invasive measurements will then be compared to the results of a standard upper endoscopy performed within 48 to 72 hours. The goal is to determine if these simple ultrasound measurements can reliably predict the presence, grade, and bleeding risk of esophageal varices, which could potentially reduce the need for routine invasive endoscopic screenings in the future.
Detailed description
Background and Rationale:
Esophageal variceal bleeding is a life-threatening complication of portal hypertension in patients with chronic liver disease. While upper gastrointestinal endoscopy remains the gold standard for diagnosing and grading esophageal varices, it is an invasive procedure. Recent studies demonstrate that non-invasive parameters, specifically ultrasonographic measurements like portal vein diameter and splenic size, have emerged as independent predictors of variceal presence and bleeding risk. Despite these findings, there is limited data from Egyptian populations, particularly from Upper Egypt. This study aims to assess the diagnostic accuracy of these measurements and establish optimal cutoff values for non-invasive parameters in this population.
Study Design and Setting:
This is a prospective cross-sectional observational study conducted at the Department of Tropical Medicine and Gastroenterology and the Department of Diagnostic Radiology at AL-Rajhi University Hospital, Assiut University, Egypt. The study aims to recruit 165 adult patients with liver cirrhosis.
Study Procedures:
All enrolled participants will undergo the following assessments:
Clinical and Laboratory Assessment: Participants will undergo comprehensive history taking and physical examinations, alongside the calculation of Child-Pugh and Model for End-Stage Liver Disease (MELD) scores. Blood samples will be evaluated for complete blood count (focusing on platelets), liver and renal function tests, and prothrombin time/INR.
Abdominal Ultrasound: A high-resolution ultrasound using a 3.5-5 MHz convex transducer will be performed to measure the longest craniocaudal splenic diameter, splenic width and thickness, and portal vein diameter at the porta hepatis. Additional assessments include splenic vein diameter, ascites, liver echotexture, and the calculation of the platelet count/spleen diameter ratio.
Upper Gastrointestinal Endoscopy: Within 48-72 hours of the ultrasound, an endoscopy will be performed. Investigators will grade the varices (Grade I-III), assess for red color signs (indicating high bleeding risk), and document any gastric varices or portal hypertensive gastropathy.
Primary outcome measures
- Grade of esophageal varices [Time frame: Baseline (at the time of upper gastrointestinal endoscopy, performed within 48 to 72 hours of the ultrasound examination)]
Eligibility criteria
Inclusion criteria
- Adult patients (age ≥18 years) with chronic liver disease and clinical/laboratory/radiological evidence of liver cirrhosis
- Both compensated and decompensated cirrhosis (Child-Pugh classes A, B, and C)
- Patients scheduled for upper gastrointestinal endoscopy
- Patients who provide informed consent
Exclusion criteria
- Previous history of endoscopic variceal band ligation or sclerotherapy
- Prior surgical portosystemic shunt procedures or transjugular intrahepatic portosystemic shunt (TIPS)
- Hepatocellular carcinoma with portal vein thrombosis
- Previous splenectomy
- Patients receiving beta-blockers for variceal bleeding prophylaxis
- Poor quality ultrasound images due to obesity or ascites
- Refusal to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07571876 · Esophageal Variceal Bleeding