Microbiology in Obstructive BIliary Disease

Clinical-Microbiological Evaluation of the Obstructive Biliary Disease

Patients admitted to hospital due to obstructive biliary disease secondary to benign and malign etiologies, undergoing ERCP, will be selected. Bile sample will be taken in ERCP procedure with sterile technique. Its macroscopic appearance will be assessed and biliary culture will be performed.

Study Overview

• Status: Recruiting
• Conditions: Biliary Disease
• Intervention / Treatment: Diagnostic test: ERCP biliary culture

Detailed Description

The sample of biliary aspirate will be assessed as follows.

1. Its macroscopic appearance will be analyzed: yellow, black, or purulent.
2. Biliary culture will be performed; if bacterial growth is observed, its identification will be carried out by means of MALDI-TOF MS mass spectrometry and antibiotic susceptibility tests will be carried out, using the automated VITEK system.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Marusia González Villarreal; Phone Number: 8112525250; Email: marusia1990@hotmail.com
• Study Contact Backup: Name: Joel Omar Jáquez Quintana; Phone Number: 8114183484; Email: jomjaqui@hotmail.com

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64620
      • Recruiting
      • Marusia González Villarreal
      • Contact: Marusia González Villarreal; Phone Number: 8112525250; Email: marusia1990@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Emergency Department with a diagnosis of obstructive biliary disease of any cause, according to clinical, laboratory, and imaging data, who have indicated an Endoscopic Retrograde Cholangiopancreatography as part of their management.

Description

Inclusion Criteria:

• Patients with diagnosis or suspicion of biliary obstruction of any cause
• Any gender
• Over 18 years of age

Exclusion Criteria:

• Patients referred and previously treated at another hospital/clinic
• Previous ERCP
• Pregnancy
• Patient refusal to enter the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with obstructive biliary disease; Patients admitted to hospital due to obstructive biliary disease secondary to benign and malign etiologies, undergoing ERCP, will be selected. Bile sample will be taken in ERCP procedure with sterile technique. Its macroscopic appearance will be assessed and biliary culture will be performed.

Diagnostic test: ERCP biliary culture; The sample of biliary aspirate will be assessed as follows.; Its macroscopic appearance will be analyzed: yellow, black, or purulent.; Biliary culture will be performed; if bacterial growth is observed, its identification will be carried out by means of MALDI-TOF MS mass spectrometry and antibiotic susceptibility tests will be carried out, using the automated VITEK system.; Other Names: MALDI-TOF MS mass spectrometry for bacteria identification; Antibiotic susceptibility for identified bacteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of bacterial isolation in the obstructive biliary disease measured by percentage calculation	Determine the prevalence by percentage measurement of bacterial isolation in bile fluid in the obstructive biliary disease in patients undergoing ERCP.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteria in the obstructed bile duct	Isolate and identify most common bacteria that colonize and infect the obstructed bile duct by means of biliary culture and MALDI-TOF MS mass spectrometry, respectively	1 year
Antibiotic susceptibility of isolated bacteria in bile fluid	Determine antibiotic susceptibility of the isolated bacteria in bile fluid of patients with obstructed bile duct by means of the automated VITEK system	1 year
Bacteria and etiology of obstructive biliary disease	Association between isolated bacteria and the etiology of obstructive biliary disease	1 year

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Investigators: Principal Investigator: Joel Omar Jáquez Quintana, Hospital Universitario Dr. Jose E. Gonzalez

Publications and helpful links

General Publications

• European Association for the Study of the Liver (EASL). Electronic address: easloffice@easloffice.eu. EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016 Jul;65(1):146-181. doi: 10.1016/j.jhep.2016.03.005. Epub 2016 Apr 13. No abstract available.
• Bornman PC, van Beljon JI, Krige JE. Management of cholangitis. J Hepatobiliary Pancreat Surg. 2003;10(6):406-14. doi: 10.1007/s00534-002-0710-1.
• Ehrenstein BP, Salamon L, Linde HJ, Messmann H, Scholmerich J, Gluck T. Clinical determinants for the recovery of fungal and mezlocillin-resistant pathogens from bile specimens. Clin Infect Dis. 2002 Apr 1;34(7):902-8. doi: 10.1086/339209. Epub 2002 Feb 26.
• Kwon JS, Han J, Kim TW, Oh JH, Kwon HH, Jung JT, Kwon JG, Kim EY, Kim HG. Changes in causative pathogens of acute cholangitis and their antimicrobial susceptibility over a period of 6 years. Korean J Gastroenterol. 2014 May;63(5):299-307. doi: 10.4166/kjg.2014.63.5.299.
• Gomi H, Solomkin JS, Schlossberg D, Okamoto K, Takada T, Strasberg SM, Ukai T, Endo I, Iwashita Y, Hibi T, Pitt HA, Matsunaga N, Takamori Y, Umezawa A, Asai K, Suzuki K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, de Santibanes E, Shikata S, Noguchi Y, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Mukai S, Higuchi R, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):3-16. doi: 10.1002/jhbp.518. Epub 2018 Jan 9.
• Gu XX, Zhang MP, Zhao YF, Huang GM. Clinical and microbiological characteristics of patients with biliary disease. World J Gastroenterol. 2020 Apr 14;26(14):1638-1646. doi: 10.3748/wjg.v26.i14.1638.
• ASGE Standards of Practice Committee, Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.
• 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.
• Negm AA, Schott A, Vonberg RP, Weismueller TJ, Schneider AS, Kubicka S, Strassburg CP, Manns MP, Suerbaum S, Wedemeyer J, Lankisch TO. Routine bile collection for microbiological analysis during cholangiography and its impact on the management of cholangitis. Gastrointest Endosc. 2010 Aug;72(2):284-91. doi: 10.1016/j.gie.2010.02.043. Epub 2010 Jun 11.
• Hillenkamp F, Karas M, Beavis RC, Chait BT. Matrix-assisted laser desorption/ionization mass spectrometry of biopolymers. Anal Chem. 1991 Dec 15;63(24):1193A-1203A. doi: 10.1021/ac00024a002. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: GA21-00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No data sharing plan

Drug and device information, study documents

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