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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Carlo Fabbri, MD; Phone Number: +39 3389353104; Email: carlo.fabbri@auslromagna.it

Study Locations

• Italy
  • Forlì-Cesena
    • Forlì, Forlì-Cesena, Italy
      • Recruiting
      • Ospedale Morgagni-Pierantoni
      • Contact: Carlo Fabbri, MD; Phone Number: + 39 3389353104; Email: carlo.fabbri@auslromagna.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any benignant or malignant ERC indication in naive papilla

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Unità Sanitaria Locale della Romagna
• Investigators: Principal Investigator: Carlo Fabbri, MD, Ausl Romagna

Publications and helpful links

General Publications

• Chandra S, Klair JS, Soota K, Livorsi DJ, Johlin FC. Endoscopic Retrograde Cholangio-Pancreatography-Obtained Bile Culture Can Guide Antibiotic Therapy in Acute Cholangitis. Dig Dis. 2019;37(2):155-160. doi: 10.1159/000493579. Epub 2018 Oct 3.
• Molinero N, Ruiz L, Milani C, Gutierrez-Diaz I, Sanchez B, Mangifesta M, Segura J, Cambero I, Campelo AB, Garcia-Bernardo CM, Cabrera A, Rodriguez JI, Gonzalez S, Rodriguez JM, Ventura M, Delgado S, Margolles A. The human gallbladder microbiome is related to the physiological state and the biliary metabolic profile. Microbiome. 2019 Jul 4;7(1):100. doi: 10.1186/s40168-019-0712-8.
• Ye F, Shen H, Li Z, Meng F, Li L, Yang J, Chen Y, Bo X, Zhang X, Ni M. Influence of the Biliary System on Biliary Bacteria Revealed by Bacterial Communities of the Human Biliary and Upper Digestive Tracts. PLoS One. 2016 Mar 1;11(3):e0150519. doi: 10.1371/journal.pone.0150519. eCollection 2016.
• Miura F, Okamoto K, Takada T, Strasberg SM, Asbun HJ, Pitt HA, Gomi H, Solomkin JS, Schlossberg D, Han HS, Kim MH, Hwang TL, Chen MF, Huang WS, Kiriyama S, Itoi T, Garden OJ, Liau KH, Horiguchi A, Liu KH, Su CH, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Endo I, Suzuki K, Yoon YS, de Santibanes E, Gimenez ME, Jonas E, Singh H, Honda G, Asai K, Mori Y, Wada K, Higuchi R, Watanabe M, Rikiyama T, Sata N, Kano N, Umezawa A, Mukai S, Tokumura H, Hata J, Kozaka K, Iwashita Y, Hibi T, Yokoe M, Kimura T, Kitano S, Inomata M, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: initial management of acute biliary infection and flowchart for acute cholangitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):31-40. doi: 10.1002/jhbp.509. Epub 2018 Jan 8.
• Nicoletti A, Ponziani FR, Nardella E, Ianiro G, Gasbarrini A, Zileri Dal Verme L. Biliary tract microbiota: a new kid on the block of liver diseases? Eur Rev Med Pharmacol Sci. 2020 Mar;24(5):2750-2775. doi: 10.26355/eurrev_202003_20548.
• Reiter FP, Obermeier W, Jung J, Denk G, Mahajan UM, De Toni EN, Schirra J, Mayerle J, Schulz C. Prevalence, Resistance Rates, and Risk Factors of Pathogens in Routine Bile Cultures Obtained during Endoscopic Retrograde Cholangiography. Dig Dis. 2021;39(1):42-51. doi: 10.1159/000509289. Epub 2020 Jun 10.
• Gomi H, Takada T, Hwang TL, Akazawa K, Mori R, Endo I, Miura F, Kiriyama S, Matsunaga N, Itoi T, Yokoe M, Chen MF, Jan YY, Ker CG, Wang HP, Wada K, Yamaue H, Miyazaki M, Yamamoto M. Updated comprehensive epidemiology, microbiology, and outcomes among patients with acute cholangitis. J Hepatobiliary Pancreat Sci. 2017 Jun;24(6):310-318. doi: 10.1002/jhbp.452. Epub 2017 May 26.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Estimated): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Skin Manifestations; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Hyperbilirubinemia; Choledocholithiasis; Jaundice; Gallbladder Diseases; Jaundice, Obstructive
• Other Study ID Numbers: 4549/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No