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

NCT ID: NCT06115564

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Jaundice, Obstructive Jaundice; Malignant Choledocholithiasis Biliary Stricture Biliary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Unità Sanitaria Locale della Romagna

OTHER

Sponsor Role lead

Responsible Party

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Carlo Fabbri

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Fabbri, MD

Role: PRINCIPAL_INVESTIGATOR

AUSL Romagna

Locations

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Ospedale Morgagni-Pierantoni

Forlì, Forlì-Cesena, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carlo Fabbri, MD

Role: CONTACT

+39 3389353104

Facility Contacts

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Carlo Fabbri, MD

Role: primary

+ 39 3389353104

References

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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.

Reference Type BACKGROUND
PMID: 32196626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31272480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28941329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32521535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30282078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26930491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28371094 (View on PubMed)

Other Identifiers

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4549/2022

Identifier Type: -

Identifier Source: org_study_id

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