Biliary Disease, Biliary Stricture, Choledocholithiasis, Jaundice; Malignant, Jaundice, Obstructive
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Azienda Unità Sanitaria Locale della Romagna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial assessment in patients undergoing to ERC with naive papilla | July 2022 to 2023 | Coltural assessment of the bile samples obtained pre- and post-sphincterotomy during ERC in naive papilla. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Check the presence of a possible association between specific biliary bacterial strains and definite pancreaticobiliary disorders. | July 2022 to 2023 | Check the presence of a possible association between specific biliary bacterial strains and definite pancreaticobiliary disorders. |
| MDR and sentinel germs detection | July 2022 to 2023 | Determine the presence and the prevalence of MDR organisms and sentinel germs in bile. |
| differences in the microbial community before and after sphincterotomy. | July 2022 to 2023 | Evaluation of differences in the microbial community before and after sphincterotomy. |
| 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 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 potential differences in the pre sphincterotomy biliary microbial community depending on type of jaundice (benign or malignant). | July 2022 to 2023 | Identify potential differences in the pre sphincterotomy biliary microbial community depending on type of jaundice (benign or malignant). |
Countries
Italy
Contacts
Primary ContactCarlo Fabbri, MD
Outcome results
None listed