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临床试验/NCT03981315
NCT03981315Unknown不适用

Gallbladder Bile Composition in Patients With Gallstones and Healthy Patients

Hospital Son Espases1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
62
试验地点
1
主要终点
Differences of bile composition between cases and controls

研究概览

简要总结

Determine differences between lithogenic and non-lithogenic bile composition.

详细描述

Gallstones constitute an entity known from antiquity, which have been found even in Egyptian mummies. In elder Greece, Tralliano discovered that gallstones are formed in the liver. Vesalio and Falopio described gallstones inside de gallbladder after a human body dissection and in 1882 Langenbuch performed the first cholecystectomy with good results, becoming the gold standard technique for cholelithiasis.

Nowadays, this pathology represents a public health problem in developed countries due to its high prevalence, which is getting higher, estimated between a 10 and a 15% of the population.

However, gallstones are asymptomatic in the 80% of the cases. In 5 years, a 10-20% of these patients will become symptomatic. The global risk of generating symptoms is about a 2% per year, meanwhile biliary tract complications in asymptomatic patients represent a 0'3% per year.

There are two main types of gallstones. The most common of them (70%) are cholesterol stones, composed of >50% of cholesterol. The other 30% are black pigment stones, with less than 20% of cholesterol in their composition.

The common ways on gallstone formation are: cholesterol supersaturation (due to a liver oversecretion); defects on gallbladder absorption, secretion and motility mechanisms; and higher percentage of deoxycholic acid in the biliary acids due to a slower intestinal movement. All of that leads to supersaturation and cholesterol nucleation.

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
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Under 16 years old
  • Hepatic or renal insufficiency
  • Impossibility to understand the aim of the study

结局指标

主要结局

Differences of bile composition between cases and controls

时间窗: Intra-operatively

Bilirrubine in mg/dL

次要结局

未报告次要终点

研究者

发起方
Hospital Son Espases
申办方类型
Other
责任方
Sponsor

研究点 (1)

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