Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Prevalence of gastric antral vascular ectasia (GAVE) among cirrhotic patients with diabetes mellitus (fasting blood sugar>126mg/dL, and/or HbA1c >6.5%), compared to cirrhotic patients without diabetes.
研究概览
简要总结
We will evaluate all out-patients and in-patients with cirrhosis, who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), for inclusion. Patients with cirrhosis, with age >18-years, who have characteristic findings of GAVE on endoscopy will be included in this study. Their clinical and biochemical features, and endoscopy findings will be compared with a gender and age-matched control group of cirrhosis without GAVE. This observational, case-control study will aim to define the predictors of GAVE in patients with cirrhosis.
详细描述
Primary Objective: To study whether GAVE is more prevalent among patients with cirrhosis who have diabetes mellitus, compared to cirrhotic patients without diabetes.
- Secondary objectives:
- Relationship of etiology of cirrhosis with occurrence of GAVE.
- Relationship of severity of cirrhosis (CTP score and MELD score), with GAVE.
- Features of metabolic syndrome among cirrhotic patients with GAVE.
- Variceal grade and previous endotherapy with occurrence of GAVE among patients with cirrhosis.
- Prevalence of proximal gastric vascular ectasias among cirrhotic patients with GAVE.
(b) Methodology:
- Study population:
All out-patients and in-patients who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), will be evaluated for inclusion. Diagnosis of cirrhosis will be based on a combination of imaging features, liver biopsy, elastography measurements, and signs of portal hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with cirrhosis, with age >18-years, who have characteristic findings of GAVE on endoscopy.
排除标准
- •Active upper GI bleeding preventing adequate mucosal evaluation.
- •Patients unable or unwilling to give informed consent.
- •Endoscopic treatment of GAVE in past one month.
结局指标
主要结局
Prevalence of gastric antral vascular ectasia (GAVE) among cirrhotic patients with diabetes mellitus (fasting blood sugar>126mg/dL, and/or HbA1c >6.5%), compared to cirrhotic patients without diabetes.
时间窗: 3 months
次要结局
- Comparison of Model for End-Stage Liver Disease (MELD) scores (on a scale of 6-40) of cirrhotic patients with GAVE and cirrhotic patients without GAVE.(3 months)
- Prevalence of proximal gastric vascular ectasias among cirrhotic patients with GAVE.(3 months)
- Comparison of the number of features of metabolic syndrome among cirrhotic patients with GAVE and cirrhotic patients without GAVE.(3 months)
- Comparison of Child Turcotte Pugh (CTP) scores (on a scale of 5-15) of cirrhotic patients with GAVE and cirrhotic patients without GAVE.(3 months)
- Grade of esophageal varices among cirrhotic patients with GAVE, compared to cirrhotic patients without GAVE.(3 months)