Splenic Size and Portal Vein Diameter on Ultrasound in Predicting Esophageal Variceal Bleeding Risk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 165
- Primary Endpoint
- Grade of esophageal varices
Study Overview
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.
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Grade of esophageal varices
Time Frame: Baseline (at the time of upper gastrointestinal endoscopy, performed within 48 to 72 hours of the ultrasound examination)
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Mireille Maged Emile Hanna
Assistant Lecturer at the Public Health Department, Faculty of Medicine, Assiut University
Assiut University