Viral Hepatitis and Gallstone Disease Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Association between ongoing hepatitis C virus infection and ultrasound or computed tomography-verified gallstone disease
研究概览
简要总结
The study aims to investigate possible associations between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease.
详细描述
Patients seeking care at emergency room at Sahlgrenska University Hospital, Gothenburg, Sweden undergoing ultrasound or computed tomography for suspected gallstone disease, will be asked if they wish to participate in the study. If they agree, a serum sample will be draw for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA. The proportion of patients with vs. without ultrasound or computed tomography-verified gallstone disease will be evaluated regarding possible ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute abdominal pain entailing an abdominal ultrasound or computed tomography for suspected gallstone disease at the emergency room at Sahlgrenska University Hospital, Gothenburg
- •Written informed consent
- •Ability to obtain 9 mL serum for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA
排除标准
- •Not willing to give written informed consent
- •Age below 18 years
结局指标
主要结局
Association between ongoing hepatitis C virus infection and ultrasound or computed tomography-verified gallstone disease
时间窗: 1 day
The proportion of patient with verified gallstone disease having detectable HCV Core antigen will be compared with the proportion among patients without verified gallstone disease.
Association between ongoing hepatitis B virus infection and ultrasound or computed tomography-verified gallstone disease
时间窗: 1 day
The proportion of patient with verified gallstone disease having detectable HBsAg will be compared with the proportion among patients without verified gallstone disease.
Association between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease
时间窗: 1 day
The proportion of patient with verified gallstone disease having detectable anti-HAV IgM, HBsAg, HCV Core antigen or HEV RNA will be compared with the proportion among patients without verified gallstone disease.
Association between ongoing hepatitis A virus infection and ultrasound or computed tomography-verified gallstone disease
时间窗: 1 day
The proportion of patient with verified gallstone disease having detectable anti-HAV IgM will be compared with the proportion among patients without verified gallstone disease.
Association between ongoing hepatitis E virus infection and ultrasound or computed tomography-verified gallstone disease
时间窗: 1 day
The proportion of patient with verified gallstone disease having detectable HEV RNA will be compared with the proportion among patients without verified gallstone disease.
次要结局
未报告次要终点
研究者
Martin Lagging, MD PhD
Principal Investigator
Göteborg University