NCT03981315

Bile Composition in Healthy and Gallstones Patients

Gallbladder Bile Composition in Patients With Gallstones and Healthy Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 62 (estimated)
• Sponsor: Hospital Son Espases · Academic / Other
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Determine differences between lithogenic and non-lithogenic bile composition.

Detailed description

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. Black pigment stones are formed of calcium bilirrubinate. The formation mechanism is not clearly defined, but there is an increment in not conjugated bilirubin levels, which is less soluble in water. These gallstones are more frequent in patients who show higher levels of this bilirubin, such as those with hemolysis, Gilbert syndrome or hereditary spherocytosis. They are also common in patients with Crohn disease (specially in those with ileal resection) and cystic fibrosis, in which exists an enterohepatic circulation alteration, driving to an increase on biliary salts and non-conjugated bilirubin levels. Our work hypothesis is that bile composition in patients with gallstones on the gallbladder is different from those who doesn't show lithiasis.

Conditions

• Cholelithiasis
• Gall Stone
• Gall Bladder Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bile test	Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
DIAGNOSTIC_TEST	Blood test	Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
DIAGNOSTIC_TEST	Gall stone study	Study of the extracted gall stones, analyzing their composition, type, etc.
DIAGNOSTIC_TEST	Microbiological bile test	Determination of the microbiological composition of the bile

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-10-01
• Completion: 2022-06-01
• First posted: 2019-06-10
• Last updated: 2019-06-10

Locations

1 site across 1 country: Spain