Ultrasound Prediction of Esophageal Variceal Bleeding Risk

NCT07571876 | Not Yet Recruiting

• 1 other identifier: Esophageal Variceal Bleeding
• Study Type: observational
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Variceal Bleeding; Ultrasonography; Esophageal Bleeding; Esophageal Varices; Liver Cirrhosis; Portal Hypertension; Chronic Liver Disease (CLD)

Keywords

portal vein diameter; splenic size; ultrasound; esophageal variceal bleeding risk

Outcome Measures

Primary Outcomes (1)

• Grade of esophageal varices

  Assessed during upper gastrointestinal endoscopy and classified according to the General Rules for Recording Endoscopic Findings: Grade I (small, straight varices), Grade II (enlarged, tortuous varices occupying \<1/3 of lumen), and Grade III (large, coil-shaped varices occupying \>1/3 of lumen).

  Baseline (at the time of upper gastrointestinal endoscopy, performed within 48 to 72 hours of the ultrasound examination)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (aged 18 years and older) with chronic liver disease and established liver cirrhosis (including both compensated and decompensated, Child-Pugh classes A, B, and C) who are scheduled for an upper gastrointestinal endoscopy at AL-Rajhi University Hospital, Assiut University, Egypt.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Esophageal and Gastric Varices; Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at the Public Health Department, Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: May 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05