Bile Composition in Healthy and Gallstones Patients

NCT03981315 | Unknown

• 1 other identifier: BILISGILMOL
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Determine differences between lithogenic and non-lithogenic bile composition.

Conditions

Cholelithiasis; Gall Stone; Gall Bladder Disease

Outcome Measures

Primary Outcomes (1)

• Differences of bile composition between cases and controls

  Bilirrubine in mg/dL

  Intra-operatively

Study Arms (3)

Lithogenic bile in symptomatic patient

Patients who are performed a cholecystectomy as a treatment of their gallbladder disease

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

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

Diagnostic Test: Bile test; Diagnostic Test: Blood test; Diagnostic Test: Microbiological bile test

Interventions

Bile test DIAGNOSTIC_TEST

Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)

Lithogenic bile in asymptomatic patient; Lithogenic bile in symptomatic patient; Non-lithogenic bile

Blood test DIAGNOSTIC_TEST

Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)

Lithogenic bile in asymptomatic patient; Lithogenic bile in symptomatic patient; Non-lithogenic bile

Gall stone study DIAGNOSTIC_TEST

Study of the extracted gall stones, analyzing their composition, type, etc.

Lithogenic bile in asymptomatic patient; Lithogenic bile in symptomatic patient

Microbiological bile test DIAGNOSTIC_TEST

Determination of the microbiological composition of the bile

Lithogenic bile in asymptomatic patient; Lithogenic bile in symptomatic patient; Non-lithogenic bile

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Under 16 years old
• Hepatic or renal insufficiency
• Impossibility to understand the aim of the study

Sponsors & Collaborators

• Hospital Son Espases: lead

Study Sites (1)

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, 07010, Spain

Location

Related Publications (7)

• Gibney EJ. Asymptomatic gallstones. Br J Surg. 1990 Apr;77(4):368-72. doi: 10.1002/bjs.1800770405.

  PMID: 2187558 BACKGROUND

• 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.

  PMID: 4696536 BACKGROUND

• 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.

  PMID: 27633032 BACKGROUND

• 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.

  PMID: 5087065 BACKGROUND

• 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.

  PMID: 16694485 BACKGROUND

• 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.

  PMID: 17127183 BACKGROUND

• 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.

  PMID: 21353662 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bile and blood

MeSH Terms

Conditions

Cholelithiasis; Gallstones; Gallbladder Diseases

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Alejandro Gil Catalán

CONTACT

695621497; alejandro.gil@ssib.es

Francesc Xavier Molina Romero

CONTACT

695621497; xmolina@ssib.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: June 1, 2022
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)