Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
62 participants
OBSERVATIONAL
2019-10-31
2022-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Lithogenic bile in symptomatic patient
Patients who are performed a cholecystectomy as a treatment of their gallbladder disease
Bile test
Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Blood test
Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Gall stone study
Study of the extracted gall stones, analyzing their composition, type, etc.
Microbiological bile test
Determination of the microbiological composition of the bile
Lithogenic bile in asymptomatic patient
Patients who are performed a cholecystectomy for another reason (cancer, organ donation) and gall stones are found
Bile test
Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Blood test
Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Gall stone study
Study of the extracted gall stones, analyzing their composition, type, etc.
Microbiological bile test
Determination of the microbiological composition of the bile
Non-lithogenic bile
Patients who are performed a cholecystectomy for another reason (cancer, organ donation) without gall stones
Bile test
Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Blood test
Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Microbiological bile test
Determination of the microbiological composition of the bile
Interventions
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Bile test
Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Blood test
Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Gall stone study
Study of the extracted gall stones, analyzing their composition, type, etc.
Microbiological bile test
Determination of the microbiological composition of the bile
Eligibility Criteria
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Inclusion Criteria
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.
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
2. Hepatic or renal insufficiency
3. Impossibility to understand the aim of the study
16 Years
100 Years
ALL
No
Sponsors
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Hospital Son Espases
OTHER
Responsible Party
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Locations
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Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Gibney EJ. Asymptomatic gallstones. Br J Surg. 1990 Apr;77(4):368-72. doi: 10.1002/bjs.1800770405.
Heller F, Bouchier IA. Cholesterol and bile salt studies on the bile of patients with cholesterol gallstones. Gut. 1973 Feb;14(2):83-8. doi: 10.1136/gut.14.2.83.
Jayanthi V, Sarika S, Varghese J, Vaithiswaran V, Sharma M, Reddy MS, Srinivasan V, Reddy GM, Rela M, Kalkura S. Composition of gallbladder bile in healthy individuals and patients with gallstone disease from north and South India. Indian J Gastroenterol. 2016 Sep;35(5):347-353. doi: 10.1007/s12664-016-0685-5. Epub 2016 Sep 16.
Mackay C, Crook JN, Smith DC, McAllister RA. The composition of hepatic and gallbladder bile in patients with gallstones. Gut. 1972 Oct;13(10):759-62. doi: 10.1136/gut.13.10.759.
Reinhold JG, Ferguson LK, Hunsberger A. THE COMPOSITION OF HUMAN GALLBLADDER BILE AND ITS RELATIONSHIP TO CHOLELITHIASIS. J Clin Invest. 1937 May;16(3):367-82. doi: 10.1172/JCI100864. No abstract available.
Shaffer EA. Gallstone disease: Epidemiology of gallbladder stone disease. Best Pract Res Clin Gastroenterol. 2006;20(6):981-96. doi: 10.1016/j.bpg.2006.05.004.
Van Erpecum KJ. Pathogenesis of cholesterol and pigment gallstones: an update. Clin Res Hepatol Gastroenterol. 2011 Apr;35(4):281-7. doi: 10.1016/j.clinre.2011.01.009. Epub 2011 Feb 25.
Other Identifiers
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BILISGILMOL
Identifier Type: -
Identifier Source: org_study_id
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