CholelithiasisNCT03981315
Bile Composition in Healthy and Gallstones Patients
An observational study of Cholelithiasis and Gall Stone, run by Hospital Son Espases at 1 site in Spain.
Trial summary
Determine differences between lithogenic and non-lithogenic bile composition. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Cholelithiasis, Gall Stone, Gall Bladder Disease
- What is being tested?
- Bile test, Blood test and Gall stone study
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2019to Jun 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- Patients included for an elective cholecystectomy.
- Normal hepatic and renal function.
- Able to understand the nature of the study.
- Wish to participate in the study and sign the informed consent.
- Patients included for an hepatectomy with gallbladder exeresis for surgery reasons, without lithiasis.
- Patients included for peritoneal carcinomatosis surgery with gallbladder exeresis for surgery reasons, without lithiasis.
Show all 10Show fewer
- Organ donors.
- Normal hepatic and renal function.
- Able to understand the nature of the study.
- Wish to participate in the study and sign the informed consent.
Who cannot join
- Under 16 years old
- Hepatic or renal insufficiency
- Impossibility to understand the aim of the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, 07010
Alejandro Gil Catalán, 695621497, alejandro.gil@ssib.es
About this study
Official title: Gallbladder Bile Composition in Patients With Gallstones and Healthy Patients
Determine differences between lithogenic and non-lithogenic bile composition.
Read the 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.
- Conditions
- Cholelithiasis, Gall Stone, Gall Bladder Disease
- Being tested
- Bile test, Blood test, Gall stone study, Microbiological bile test
- Medical subject headings
- Cholelithiasis, Gallstones, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bile testDiagnostic test
Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Blood testDiagnostic test
Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
Gall stone studyDiagnostic test
Study of the extracted gall stones, analyzing their composition, type, etc.
Microbiological bile testDiagnostic test
Determination of the microbiological composition of the bile
| Study group | Role | What they receive |
|---|---|---|
| Lithogenic bile in symptomatic patient | Patients who are performed a cholecystectomy as a treatment of their gallbladder disease Receives: Diagnostic Test: Bile test; Diagnostic Test: Blood test; Diagnostic Test: Gall stone study; Diagnostic Test: Microbiological bile test | |
| Lithogenic bile in asymptomatic patient | Patients who are performed a cholecystectomy for another reason (cancer, organ donation) and gall stones are found Receives: Diagnostic Test: Bile test; Diagnostic Test: Blood test; Diagnostic Test: Gall stone study; Diagnostic Test: Microbiological bile test | |
| Non-lithogenic bile | Patients who are performed a cholecystectomy for another reason (cancer, organ donation) without gall stones Receives: Diagnostic Test: Bile test; Diagnostic Test: Blood test; Diagnostic Test: Microbiological bile test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of bile composition between cases and controls
Bilirrubine in mg/dL
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Son Espases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981315
- Sponsor's protocol ID
- BILISGILMOL
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibney EJ. Asymptomatic gallstones. Br J Surg. 1990 Apr;77(4):368-72. doi: 10.1002/bjs.1800770405.
PubMed 2187558Heller 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.
PubMed 4696536Jayanthi 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.
PubMed 27633032Mackay 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.
PubMed 5087065Reinhold 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.
PubMed 16694485Shaffer 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.
PubMed 17127183Van 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.
PubMed 21353662
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallbladder Bile Composition in Patients With Gallstones and Healthy Patients
- ClinicalTrials.gov ID
- NCT03981315
- Acronym / sponsor ID
- BILISGILMOL
- Conditions
- Cholelithiasis, Gall Stone, Gall Bladder Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hospital Son EspasesUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lithogenic bile in symptomatic patient | – | Diagnostic Test: Bile test, Diagnostic Test: Blood test, Diagnostic Test: Gall stone study, Diagnostic Test: Microbiological bile testPatients who are performed a cholecystectomy as a treatment of their gallbladder disease |
| Lithogenic bile in asymptomatic patient | – | Diagnostic Test: Bile test, Diagnostic Test: Blood test, Diagnostic Test: Gall stone study, Diagnostic Test: Microbiological bile testPatients who are performed a cholecystectomy for another reason (cancer, organ donation) and gall stones are found |
| Non-lithogenic bile | – | Diagnostic Test: Bile test, Diagnostic Test: Blood test, Diagnostic Test: Microbiological bile testPatients who are performed a cholecystectomy for another reason (cancer, organ donation) without gall stones |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (10 listed)
- Patients included for an elective cholecystectomy.
- Normal hepatic and renal function.
- Able to understand the nature of the study.
- Wish to participate in the study and sign the informed consent.
- Patients included for an hepatectomy with gallbladder exeresis for surgery reasons, without lithiasis.
Key exclusion criteria (3 listed)
- Under 16 years old
- Hepatic or renal insufficiency
- Impossibility to understand the aim of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bile testAnalyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.) | Diagnostic test | Lithogenic bile in asymptomatic patient, Lithogenic bile in symptomatic patient, Non-lithogenic bile |
| Blood testAnalyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.) | Diagnostic test | Lithogenic bile in asymptomatic patient, Lithogenic bile in symptomatic patient, Non-lithogenic bile |
| Gall stone studyStudy of the extracted gall stones, analyzing their composition, type, etc. | Diagnostic test | Lithogenic bile in asymptomatic patient, Lithogenic bile in symptomatic patient |
| Microbiological bile testDetermination of the microbiological composition of the bile | Diagnostic test | Lithogenic bile in asymptomatic patient, Lithogenic bile in symptomatic patient, Non-lithogenic bile |
Primary outcome
Differences of bile composition between cases and controls
Time frame: Intra-operatively
Bilirrubine in mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Background: PubMed 2187558Gibney EJ. Asymptomatic gallstones. Br J Surg. 1990 Apr;77(4):368-72. doi: 10.1002/bjs.1800770405.
- Background: PubMed 4696536Heller 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.
- Background: PubMed 27633032Jayanthi 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.
- Background: PubMed 5087065Mackay 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.
- Background: PubMed 16694485Reinhold 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.
- Background: PubMed 17127183Shaffer 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.
- Background: PubMed 21353662Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis and Gall Stone, run by Hospital Son Espases at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Gil Catalán (695621497, alejandro.gil@ssib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of bile composition between cases and controls (time frame: Intra-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981315, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.