Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]

Study Overview
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Brief Summary
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The performance of the microbiota is observed in all clinical and pathological stages of carcinogenesis, since its development, diagnosis and treatment, including prognosis and survival. However, it was found that there is a scarcity of studies on biliary microbiota and its relationship with hepatobiliopancreatic diseases. Therefore, further investigation is necessary, since reaching the biliary microbiota may suggest ways for studies of biomarkers, diagnoses, tests and therapies in hepatobiliopancreatic diseases. For this, bile samples will be collected in cases and controls patients to characterize the microbiota and its variations according to the disease.

Official Title
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Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]

Conditions
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Pancreatic Diseases, Microbiota, Early Detection of Cancer, Dysbiosis, Biliary Tract Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endoscopic retrograde cholangiopancreatography (ERCP) candidates (case group) Patients over 18 years old complete Patients previously scheduled for ERCP Cannulation of the bile duct, via the transpapillary route, with the aid of a papillotome with an end kept sterile until contact with the papilla Liver transplant living-donor (control group) Patients over 18 years old up to 55 years Previously selected patients with scheduled surgery BMI: 18 kg / m² to 28 kg / m² Blood typing identical to the recipient Absence of significant medical, psychiatric problems or previous abdominal surgery Normal laboratory tests: liver function tests, blood count, coagulogram, pregnancy test and serology for hepatitis B, C and HIV Normal imaging exams: CT of the abdomen and pelvis with liver volume (remaining volume - 30-40% of the total liver volume), MRI with cholangioresonance Exclusion Criteria: ERCP candidates (case group) Use of antibiotics during ERCP or in the last 2 months prior to the procedure Emergency ERCP Pregnancy Uncorrected coagulopathy Liver transplant living-donor (control group) Use of antibiotics in the last 2 months prior to the procedure Pregnancy Uncorrected coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who will undergo ERCP (case group)<br> | |
| Living liver transplantation donors (control group)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of the biliary microbiota | In this study, the investigator's objective will be to characterize the specific composition of the biliary microbiota in patients with hepatobiliopancreatic diseases in comparison with healthy people using 16S ribosomal RNA (rRNA) pyrosequencing methods. | 2 years |