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临床试验/NCT01810081
NCT01810081Unknown不适用

Study of Relationship Between Gallstones and Concomitant Gastric Helicobacter Pylori Infection

Marmara University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
94
试验地点
1
主要终点
Gallstones and concomitant H.Pylori infection of the gastric mucosa

研究概览

简要总结

In this study, the presence of H.Pylori in the gallbladder mucosa of patients with symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori infection of the gastric mucosa was also investigated to study the relationship of gastric H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric mucosa may have a role in the formation of gallstones.

详细描述

Gallstone disease is one of the most common problems affecting the digestive tract where autopsy reports show a prevalence of 11-36% . The prevalence of gallstones is related to many factors including age, gender, and ethnic background. Women are three times more likely to develop gallstones than man and first-degree relatives have a two-fold increased prevalence . However, the etiology of gallstone formation beginning with the change in the composition of bile, leading to stones is not clear.

The association between Helicobacter pylori (H.Pylori) and gallstones has been investigated but not clearly demonstrated. H.Pylori is a gram negative and micro-aerophilic microorganism that can cause chronic gastritis, gastric and duodenal ulcers, gastric adenocarcinoma and lymphoma of gastric mucosa-related lymphoid tissue (MALToma) . Relationship of H.Pylori with diseases of organs other than the stomach and duodenum has also been investigated and reported . H.Pylori have been detected in the gallbladder mucosa of patients with gallstones .

In this study, the presence of H.Pylori in the gallbladder mucosa of patients with symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori infection of the gastric mucosa was also investigated to study the relationship of gastric H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric mucosa may have a role in the formation of gallstones.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute cholecystitis, cholangitis, biliary and hepatic tumors, Crohn's disease, and previous gastric surgery were not considered suitable for evaluation.

排除标准

  • Patients undergoing ERCP (endoscopic retrograde cholangio-pancreatography) and patients who have received H.Pylori eradication treatment in the last 6 month were also excluded from the study.

结局指标

主要结局

Gallstones and concomitant H.Pylori infection of the gastric mucosa

时间窗: 3 months

The relationship between gastric H.Pylori infection and comcomitant gallstones will be evaluated

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

M.Umit UGURLU

Assist.Prof.

Marmara University

研究点 (1)

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