Bile Composition in Healthy and Gallstones Patients

• Conditions: Gall Stone; Cholelithiasis; Gall Bladder Disease
• Interventions: Diagnostic Test: Bile test; Diagnostic Test: Blood test; Diagnostic Test: Gall stone study; Diagnostic Test: Microbiological bile test

• Registration Number: NCT03981315
• Lead Sponsor: Hospital Son Espases

Brief 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.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-07
• Last Update Submitted: 2019-06-07
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10
• Study Start: 2019-10
• Primary Completion: 2021-10
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

1. Under 16 years old
2. Hepatic or renal insufficiency
3. Impossibility to understand the aim of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lithogenic bile in asymptomatic patient	Microbiological bile test	Patients who are performed a cholecystectomy for another reason (cancer, organ donation) and gall stones are found
Lithogenic bile in symptomatic patient	Microbiological bile test	Patients who are performed a cholecystectomy as a treatment of their gallbladder disease
Lithogenic bile in symptomatic patient	Blood test	Patients who are performed a cholecystectomy as a treatment of their gallbladder disease
Non-lithogenic bile	Blood test	Patients who are performed a cholecystectomy for another reason (cancer, organ donation) without gall stones
Lithogenic bile in symptomatic patient	Gall stone study	Patients who are performed a cholecystectomy as a treatment of their gallbladder disease
Lithogenic bile in asymptomatic patient	Blood test	Patients who are performed a cholecystectomy for another reason (cancer, organ donation) and gall stones are found
Non-lithogenic bile	Bile test	Patients who are performed a cholecystectomy for another reason (cancer, organ donation) without gall stones
Non-lithogenic bile	Microbiological bile test	Patients who are performed a cholecystectomy for another reason (cancer, organ donation) without gall stones
Lithogenic bile in symptomatic patient	Bile test	Patients who are performed a cholecystectomy as a treatment of their gallbladder disease
Lithogenic bile in asymptomatic patient	Bile test	Patients who are performed a cholecystectomy for another reason (cancer, organ donation) and gall stones are found
Lithogenic bile in asymptomatic patient	Gall stone study	Patients who are performed a cholecystectomy for another reason (cancer, organ donation) and gall stones are found

Primary Outcome Measures

Name	Time	Method
Differences of bile composition between cases and controls	Intra-operatively	Bilirrubine in mg/dL

Trial Locations

Locations (1)

Hospital Universitario Son Espases; 🇪🇸 Palma De Mallorca, Mallorca, Spain