Study Results
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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UNKNOWN
70 participants
OBSERVATIONAL
2021-08-24
2022-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
ERCP biliary culture
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.
Interventions
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ERCP biliary culture
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any gender
* Over 18 years of age
Exclusion Criteria
* Previous ERCP
* Pregnancy
* Patient refusal to enter the study
18 Years
ALL
No
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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Dr. med. Hector Eloy Tamez Perez
Clinical professor
Principal Investigators
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Joel Omar Jáquez Quintana
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Dr. Jose E. Gonzalez
Locations
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Marusia González Villarreal
Monterrey, Nuevo León, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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European Association for the Study of the Liver (EASL). Electronic address: [email protected]. 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.
Other Identifiers
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GA21-00003
Identifier Type: -
Identifier Source: org_study_id
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