Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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).
- 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.
Eligibility Criteria
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:
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Patients who have already undergone endoscopic sphincterotomy
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Patients unable to express informed consent
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Pregnant or breastfeeding women
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Patients with anatomical post-surgical alterations of the upper gastrointestinal (GI) tract
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ospedale Morgagni-Pierantoni | Forlì | Forlì-Cesena | Italy |
Sponsors and Collaborators
- Azienda Unità Sanitaria Locale della Romagna
Investigators
- Principal Investigator: Carlo Fabbri, MD, AUSL Romagna
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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