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Bile Composition in Healthy and Gallstones Patients

Gallbladder Bile Composition in Patients With Gallstones and Healthy Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03981315
Enrollment
62
Registered
2019-06-10
Start date
2019-10-31
Completion date
2022-06-30
Last updated
2019-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis, Gall Bladder Disease, Gall Stone

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.

Interventions

DIAGNOSTIC_TESTBile test

Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)

DIAGNOSTIC_TESTBlood test

Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)

DIAGNOSTIC_TESTGall stone study

Study of the extracted gall stones, analyzing their composition, type, etc.

DIAGNOSTIC_TESTMicrobiological bile test

Determination of the microbiological composition of the bile

Sponsors

Hospital Son Espases
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

for the Study Group: 1. Patients included for an elective cholecystectomy. 2. Normal hepatic and renal function. 3. Able to understand the nature of the study. 4. Wish to participate in the study and sign the informed consent. Inclusion Criteria for the Control Group: 1. Patients included for an hepatectomy with gallbladder exeresis for surgery reasons, without lithiasis. 2. Patients included for peritoneal carcinomatosis surgery with gallbladder exeresis for surgery reasons, without lithiasis. 3. Organ donors. 4. Normal hepatic and renal function. 5. Able to understand the nature of the study. 6. Wish to participate in the study and sign the informed consent.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Differences of bile composition between cases and controlsIntra-operativelyBilirrubine in mg/dL

Countries

Spain

Contacts

Primary ContactAlejandro Gil Catalán
alejandro.gil@ssib.es695621497
Backup ContactFrancesc Xavier Molina Romero
xmolina@ssib.es695621497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026