An observational study in Jaundice, Obstructive, Jaundice; Malignant and Choledocholithiasis, sponsored by Azienda Unità Sanitaria Locale della Romagna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by Azienda Unità Sanitaria Locale della Romagna · Observational
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.
62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.
This study's planned enrollment of 200 is above the median of 125 across 20 observational studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →Azienda Unità Sanitaria Locale della Romagna is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Any benignant or malignant ERC indication in naive papilla
Main inclusion criteria for patient enrollment were: ability to provide an ; age >/=18 years; any benignant or malignant ERCP indication.
All subjects were excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: July 2022 to 2023
MDR and sentinel germs detection
Determine the presence and the prevalence of MDR organisms and sentinel germs in bile.
Time frame: July 2022 to 2023
differences in the microbial community before and after sphincterotomy.
Evaluation of differences in the microbial community before and after sphincterotomy.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: July 2022 to 2023
Started Jul 2022 (actual). Primary completion is estimated for Dec 2023, 17 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Unità Sanitaria Locale della Romagna