Condition or disease | Intervention/treatment |
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Cholelithiasis Gall Stone Gall Bladder Disease | Diagnostic Test: Bile test Diagnostic Test: Blood test Diagnostic Test: Gall stone study Diagnostic Test: Microbiological bile test |
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 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 |
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
|
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 |
Inclusion Criteria for the Study Group:
Inclusion Criteria for the Control Group:
Exclusion Criteria:
Contact: Alejandro Gil Catalán | 695621497 | alejandro.gil@ssib.es | |
Contact: Francesc Xavier Molina Romero | 695621497 | xmolina@ssib.es |
Spain | |
Hospital Universitario Son Espases | |
Palma De Mallorca, Mallorca, Spain, 07010 | |
Contact: Alejandro Gil Catalán 695621497 alejandro.gil@ssib.es |
Tracking Information | |||||||||
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First Submitted Date | June 4, 2019 | ||||||||
First Posted Date | June 10, 2019 | ||||||||
Last Update Posted Date | June 10, 2019 | ||||||||
Estimated Study Start Date | October 2019 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Differences of bile composition between cases and controls [ Time Frame: Intra-operatively ] Bilirrubine in mg/dL
|
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Bile Composition in Healthy and Gallstones Patients | ||||||||
Official Title | Gallbladder Bile Composition in Patients With Gallstones and Healthy Patients | ||||||||
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. |
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Study Type | Observational [Patient Registry] | ||||||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | 2 Years | ||||||||
Biospecimen | Retention: Samples With DNA Description:
Bile and blood
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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) | ||||||||
Condition |
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Intervention |
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
62 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | June 2022 | ||||||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria for the Study Group:
Inclusion Criteria for the Control Group:
Exclusion Criteria:
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Sex/Gender |
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Ages | 16 Years to 100 Years (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Spain | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03981315 | ||||||||
Other Study ID Numbers | BILISGILMOL | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Hospital Son Espases | ||||||||
Study Sponsor | Hospital Son Espases | ||||||||
Collaborators | Not Provided | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | Hospital Son Espases | ||||||||
Verification Date | June 2019 |