Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the Microbile Registry

Study Overview
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Brief Summary
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The study is a prospective evaluation of the microbial assessment in patients undergoing to ERC with naive papilla; the population includes all the indication to biliary drainage.

Official Title
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Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the Microbile Registry

Conditions
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Jaundice, Obstructive, Jaundice; Malignant, Choledocholithiasis, Biliary Stricture, Biliary Disease

Participation Criteria
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Eligibility Criteria
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Main inclusion criteria for patient enrollment were: ability to provide an informed consent; age >/=18 years; any benignant or malignant ERCP indication. All subjects were excluded from the study: Patients who have already undergone endoscopic sphincterotomy Patients unable to express informed consent Pregnant or breastfeeding women Patients with anatomical post-surgical alterations of the upper gastrointestinal (GI) tract

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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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial assessment in patients undergoing to ERC with naive papilla | Coltural assessment of the bile samples obtained pre- and post-sphincterotomy during ERC in naive papilla. | July 2022 to 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDR and sentinel germs detection | Determine the presence and the prevalence of MDR organisms and sentinel germs in bile. | July 2022 to 2023 | 
| differences in the microbial community before and after sphincterotomy. | Evaluation of differences in the microbial community before and after sphincterotomy. | July 2022 to 2023 | 
| Identify possible correlations between pre sphincterotomy positive biliary cultures, polymicrobial population and MDR organisms with several clinical features and with laboratory signs of acute cholangitis. | Identify possible correlations between pre sphincterotomy positive biliary cultures, polymicrobial population and MDR organisms with several clinical features and with laboratory signs of acute cholangitis. | July 2022 to 2023 | 
| Identify potential differences in the pre sphincterotomy biliary microbial community depending on type of jaundice (benign or malignant). | Identify potential differences in the pre sphincterotomy biliary microbial community depending on type of jaundice (benign or malignant). | July 2022 to 2023 | 
| Check the presence of a possible association between specific biliary bacterial strains and definite pancreaticobiliary disorders. | Check the presence of a possible association between specific biliary bacterial strains and definite pancreaticobiliary disorders. | July 2022 to 2023 |