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

Azienda Unità Sanitaria Locale della Romagna1 site in 1 country200 target enrollmentJuly 1, 2022

ConditionsJaundice, Obstructive Jaundice; Malignant Choledocholithiasis Biliary Stricture Biliary Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Jaundice, Obstructive
Sponsor: Azienda Unità Sanitaria Locale della Romagna
Enrollment: 200
Locations: 1
Primary Endpoint: Microbial assessment in patients undergoing to ERC with naive papilla
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Azienda Unità Sanitaria Locale della Romagna

Responsible Party

Principal Investigator

Carlo Fabbri

Azienda Unità Sanitaria Locale della Romagna

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Microbial assessment in patients undergoing to ERC with naive papilla

Time Frame: July 2022 to 2023

Coltural assessment of the bile samples obtained pre- and post-sphincterotomy during ERC in naive papilla.

Secondary Outcomes

Check the presence of a possible association between specific biliary bacterial strains and definite pancreaticobiliary disorders.(July 2022 to 2023)
Identify potential differences in the pre sphincterotomy biliary microbial community depending on type of jaundice (benign or malignant).(July 2022 to 2023)
differences in the microbial community before and after sphincterotomy.(July 2022 to 2023)
MDR and sentinel germs detection(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.(July 2022 to 2023)