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

University of Sao Paulo

Status: Unknown

Conditions: Early Detection of Cancer; Dysbiosis; Pancreatic Diseases; Biliary Tract Diseases; Microbiota

Study type: Observational

Funder types: Other

Identifiers

NCT04391426

29547920.9.0000.0068

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Patients who will undergo ERCP (case group)

Living liver transplantation donors (control group)