A Multicenter Case-control Study of the Association Between the Presence of Gallstone Disease and Risk of Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,035
- 试验地点
- 4
- 主要终点
- The odds ratio of the association between the presence of gallstone disease and risk of inflammatory bowel disease
研究概览
简要总结
The purpose of this study was to evaluate the association between gallstone disease and the risk of inflammatory bowel disease.
详细描述
Crohn's disease and ulcerative colitis , collectively known as inflammatory bowel diseases , have increased substantially over the past few decades affecting nearly 6.8 million individuals worldwide. The etiology of IBD remains obscure, possibly involving a complex interaction between the genetic, environmental or microbial factors and the immune responses. Gallstone disease is one of the most common and costly gastroenterological disorders, with a prevalence of 10-20% in Europe and America. Considering that gallstones and IBD also share specific risk factors, such as obesity, inappropriate diet and metabolic hormone levels, and have the pathophysiologic linkage, such as changes in gut microbiota composition and bile acid profile, the investigators propose that the occurrence of gallstones may predict the subsequence risk of IBD. However, investigations concerning the association is lacking.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years old
- •IBD established by standard criteria, either Crohn's disease or ulcerative colitis
排除标准
- •Pregnant or nursing woman;
- •Prior abdominal surgery related to IBD, such as subtotal or total colectomy;
- •HIV infection or any congenital immunodeficiency at the time of inclusion;
- •Post organ transplant patients;
- •Patients suffering from cancer currently or in the past;
- •Patients suffering from significant cardiovascular disease;
- •Patients suffering from significant respiratory diseases;
- •Patients suffering from any other chronic severe diseases.
结局指标
主要结局
The odds ratio of the association between the presence of gallstone disease and risk of inflammatory bowel disease
时间窗: 10 years
The odds ratio is a ratio of two sets of odds: the odds in case group (gallstone diseases with IBD divided by non-gallstone disease with IBD) versus the odds in control group (gallstone diseases without IBD divided by non-gallstone disease without IBD). Finally, we can calculate the odds ratio by dividing the ratio of the case group by the ratio of the control group.
The prevalence of gallstone disease among patients with or without IBD
时间窗: 10 years
We assess the prevalence as the number of gallstone diseases divided by the number of IBD patients or non-IBD patients. Gallstone disease was diagnosed as presence of gallstones, cholecystectomy, choledocholithotomy and Endoscopic Retrograde Cholangio-Pancreatography (ERCP).
次要结局
未报告次要终点
研究者
Wenbo Meng
Director of Surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province