Ultrasound Prediction of Esophageal Variceal Bleeding Risk
Splenic Size and Portal Vein Diameter on Ultrasound in Predicting Esophageal Variceal Bleeding Risk
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Grade of esophageal varices
大体时间: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).
|
Baseline (at the time of upper gastrointestinal endoscopy, performed within 48 to 72 hours of the ultrasound examination)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Esophageal Variceal Bleeding
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