Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
NCT ID: NCT04391426
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-06-03
2024-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients who will undergo ERCP (case group)
No interventions assigned to this group
Living liver transplantation donors (control group)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Alberto Meyer, MD PhD FACS
Principal Investigator
Locations
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University of Sao Paulo School of Medicine
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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29547920.9.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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