Microbiology in Obstructive BIliary Disease

Biliary Disease Clinical Trial

Official title:

Clinical-Microbiological Evaluation of the Obstructive Biliary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464693
• Other study ID #: GA21-00003
• Status: Recruiting
• Start date: August 24, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: July 2022
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Marusia González Villarreal
• Phone: 8112525250
• Email: marusia1990[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Disease
• Gallbladder Diseases

Intervention

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.

Locations

Country	Name	City	State
Mexico	Marusia González Villarreal	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (10)

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. — View Citation

Bornman PC, van Beljon JI, Krige JE. Management of cholangitis. J Hepatobiliary Pancreat Surg. 2003;10(6):406-14. Review. — View Citation

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

Ehrenstein BP, Salamon L, Linde HJ, Messmann H, Schölmerich J, Glück 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. Epub 2002 Feb 26. — View Citation

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. — View Citation

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 Santibañes 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, Giménez 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Bacteria and etiology of obstructive biliary disease	Association between isolated bacteria and the etiology of obstructive biliary disease	1 year