Microbiology in Obstructive BIliary Disease

NCT05464693 | Unknown DMC

• 1 other identifier: GA21-00003
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bacteria in the obstructed bile duct

  1 year

• Antibiotic susceptibility of isolated bacteria in bile fluid

  1 year

• Bacteria and etiology of obstructive biliary disease

  1 year

Study Arms (1)

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

Interventions

ERCP biliary culture DIAGNOSTIC_TEST

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.

Also known as: MALDI-TOF MS mass spectrometry for bacteria identification, Antibiotic susceptibility for identified bacteria

Patients with obstructive biliary disease

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

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Marusia González Villarreal

Monterrey, Nuevo León, 64620, Mexico

RECRUITING

Related Publications (10)

• 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.

  PMID: 27085810 BACKGROUND

• 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.

  PMID: 14714159 BACKGROUND

• 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.

  PMID: 11880954 BACKGROUND

• 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.

  PMID: 24870302 BACKGROUND

• 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.

  PMID: 29090866 BACKGROUND

• 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.

  PMID: 32327912 BACKGROUND

• 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.

  PMID: 30979521 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

• 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.

  PMID: 20541201 BACKGROUND

• 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.

  PMID: 1789447 BACKGROUND

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Joel Omar Jáquez Quintana

  Hospital Universitario Dr. Jose E. Gonzalez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marusia González Villarreal

CONTACT

8112525250; marusia1990@hotmail.com

Joel Omar Jáquez Quintana

CONTACT

8114183484; jomjaqui@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 19, 2022
• Study Start: August 24, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)