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

Choledocholithiasis Clinical Trial

— Microbile  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115564
• Other study ID #: 4549/2022
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Azienda Unità Sanitaria Locale della Romagna
• Contact: Carlo Fabbri, MD
• Phone: +39 3389353104
• Email: carlo.fabbri[@]auslromagna.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Disease
• Biliary Stricture
• Choledocholithiasis
• Gallbladder Diseases
• Jaundice
• Jaundice, Obstructive
• Jaundice; Malignant

Locations

Country	Name	City	State
Italy	Ospedale Morgagni-Pierantoni	Forlì	Forlì-Cesena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale della Romagna

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MDR and sentinel germs detection	Determine the presence and the prevalence of MDR organisms and sentinel germs in bile.	July 2022 to 2023
Secondary	differences in the microbial community before and after sphincterotomy.	Evaluation of differences in the microbial community before and after sphincterotomy.	July 2022 to 2023
Secondary	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
Secondary	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
Secondary	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