Bile Composition in Healthy and Gallstones Patients

Cholelithiasis Clinical Trial

Official title:

Gallbladder Bile Composition in Patients With Gallstones and Healthy Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03981315
• Other study ID #: BILISGILMOL
• Status: Not yet recruiting
• Start date: October 2019
• Est. completion date: June 2022

Study information

• Verified date: June 2019
• Source: Hospital Son Espases
• Contact: Alejandro Gil Catalán
• Phone: 695621497
• Email: alejandro.gil[@]ssib.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Determine differences between lithogenic and non-lithogenic bile composition.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: June 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gall Bladder Disease
• Gall Stone
• Gallbladder Diseases
• Gallstones
• Urinary Bladder Diseases

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Mallorca

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Son Espases

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Gibney EJ. Asymptomatic gallstones. Br J Surg. 1990 Apr;77(4):368-72. Review. — View Citation

Heller F, Bouchier IA. Cholesterol and bile salt studies on the bile of patients with cholesterol gallstones. Gut. 1973 Feb;14(2):83-8. — View Citation

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. Epub 2016 Sep 16. — View Citation

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. — View Citation

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. — View Citation

Shaffer EA. Gallstone disease: Epidemiology of gallbladder stone disease. Best Pract Res Clin Gastroenterol. 2006;20(6):981-96. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences of bile composition between cases and controls	Bilirrubine in mg/dL	Intra-operatively