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

Recruiting

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

• Registration Number: NCT06115564
• Lead Sponsor: Azienda Unità Sanitaria Locale della Romagna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
differences in the microbial community before and after sphincterotomy.	July 2022 to 2023	Evaluation of differences in the microbial community before and after sphincterotomy.
MDR and sentinel germs detection	July 2022 to 2023	Determine the presence and the prevalence of MDR organisms and sentinel germs in bile.
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.

Trial Locations

Locations (1)

Ospedale Morgagni-Pierantoni; 🇮🇹 Forlì, Forlì-Cesena, Italy