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Bile Composition in Healthy and Gallstones Patients

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ClinicalTrials.gov Identifier: NCT03981315
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Son Espases

Brief Summary:
Determine differences between lithogenic and non-lithogenic bile composition.

Condition or disease Intervention/treatment
Cholelithiasis Gall Stone Gall Bladder Disease Diagnostic Test: Bile test Diagnostic Test: Blood test Diagnostic Test: Gall stone study Diagnostic Test: Microbiological bile test

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 62 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Gallbladder Bile Composition in Patients With Gallstones and Healthy Patients
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Group/Cohort Intervention/treatment
Lithogenic bile in symptomatic patient
Patients who are performed a cholecystectomy as a treatment of their gallbladder disease
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

Lithogenic bile in asymptomatic patient
Patients who are performed a cholecystectomy for another reason (cancer, organ donation) and gall stones are found
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

Non-lithogenic bile
Patients who are performed a cholecystectomy for another reason (cancer, organ donation) without gall stones
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: Microbiological bile test
Determination of the microbiological composition of the bile




Primary Outcome Measures :
  1. Differences of bile composition between cases and controls [ Time Frame: Intra-operatively ]
    Bilirrubine in mg/dL


Biospecimen Retention:   Samples With DNA
Bile and blood


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
It includes patients who suffer from gallstones, which are operated for that reason (open or laparoscopic cholecystectomy), and patients who go through the same intervention for other reasons (cancer, organ donation)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981315


Contacts
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Contact: Alejandro Gil Catalán 695621497 alejandro.gil@ssib.es
Contact: Francesc Xavier Molina Romero 695621497 xmolina@ssib.es

Locations
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Spain
Hospital Universitario Son Espases
Palma De Mallorca, Mallorca, Spain, 07010
Contact: Alejandro Gil Catalán    695621497    alejandro.gil@ssib.es   
Sponsors and Collaborators
Hospital Son Espases
Publications:
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Responsible Party: Hospital Son Espases
ClinicalTrials.gov Identifier: NCT03981315    
Other Study ID Numbers: BILISGILMOL
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Gallbladder Diseases
Urinary Bladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Urologic Diseases