Clinical trial NCT04391426: Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
Official title: Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Diseases
Microbiota
Early Detection of Cancer
Dysbiosis
Biliary Tract Diseases
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care adult patients with hepatobiliopancreatic diseases compared to healthy people, that are living donors of liver transplant

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composition of the biliary microbiota
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo School of Medicine
Study officials:
References:
citation: Nascimento FSD, Suzuki MO, Taba JV, de Mattos VC, Pipek LZ, D'Albuquerque EMC, Iuamoto L, Meyer A, Andraus W, Pinho JRR, de Moura EGH, Setubal JC, Carneiro-D'Albuquerque LA. Analysis of biliary MICRObiota in hepatoBILIOpancreatic diseases compared to healthy people [MICROBILIO]: Study protocol. PLoS One. 2020 Nov 19;15(11):e0242553. doi: 10.1371/journal.pone.0242553. eCollection 2020.