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

NCT06115564 | Unknown

• 1 other identifier: 4549/2022
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaundice, Obstructive; Jaundice; Malignant; Choledocholithiasis; Biliary Stricture; Biliary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• MDR and sentinel germs detection

  July 2022 to 2023

• 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.

  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

• Check the presence of a possible association between specific biliary bacterial strains and definite pancreaticobiliary disorders.

  July 2022 to 2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any benignant or malignant ERC indication in naive papilla

You may qualify if:

• 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

Sponsors & Collaborators

• Azienda Unità Sanitaria Locale della Romagna: lead

Study Sites (1)

Ospedale Morgagni-Pierantoni

Forlì, Forlì-Cesena, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 32196626 BACKGROUND

• 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.

  PMID: 31272480 BACKGROUND

• 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.

  PMID: 28941329 BACKGROUND

• 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.

  PMID: 32521535 BACKGROUND

• 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.

  PMID: 30282078 BACKGROUND

• 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.

  PMID: 26930491 BACKGROUND

• 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.

  PMID: 28371094 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples of bile containing DNA of the microbial components.

MeSH Terms

Conditions

Jaundice, Obstructive; Jaundice; Choledocholithiasis; Gallbladder Diseases

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Study Officials

• Carlo Fabbri, MD

  AUSL Romagna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Fabbri, MD

CONTACT

+39 3389353104; carlo.fabbri@auslromagna.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-10

Locations

IT (1)