Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-27 @ 3:11 AM
Study NCT ID:
NCT05464693
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiology in Obstructive BIliary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2022-06-15', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of bacterial isolation in the obstructive biliary disease measured by percentage calculation', 'timeFrame': '1 year', 'description': 'Determine the prevalence by percentage measurement of bacterial isolation in bile fluid in the obstructive biliary disease in patients undergoing ERCP.'}], 'secondaryOutcomes': [{'measure': 'Bacteria in the obstructed bile duct', 'timeFrame': '1 year', 'description': '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'}, {'measure': 'Antibiotic susceptibility of isolated bacteria in bile fluid', 'timeFrame': '1 year', 'description': 'Determine antibiotic susceptibility of the isolated bacteria in bile fluid of patients with obstructed bile duct by means of the automated VITEK system'}, {'measure': 'Bacteria and etiology of obstructive biliary disease', 'timeFrame': '1 year', 'description': 'Association between isolated bacteria and the etiology of obstructive biliary disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Disease']}, 'referencesModule': {'references': [{'pmid': '27085810', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '14714159', 'type': 'BACKGROUND', 'citation': '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': '11880954', 'type': 'BACKGROUND', 'citation': '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': '24870302', 'type': 'BACKGROUND', '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. doi: 10.4166/kjg.2014.63.5.299.'}, {'pmid': '29090866', 'type': 'BACKGROUND', '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 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': '32327912', 'type': 'BACKGROUND', '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.'}, {'pmid': '30979521', 'type': 'BACKGROUND', 'citation': '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': '30282078', 'type': 'BACKGROUND', '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.'}, {'pmid': '20541201', 'type': 'BACKGROUND', '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.'}, {'pmid': '1789447', 'type': 'BACKGROUND', '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. doi: 10.1021/ac00024a002. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The sample of biliary aspirate will be assessed as follows.\n\n1. Its macroscopic appearance will be analyzed: yellow, black, or purulent.\n2. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis or suspicion of biliary obstruction of any cause\n* Any gender\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Patients referred and previously treated at another hospital/clinic\n* Previous ERCP\n* Pregnancy\n* Patient refusal to enter the study'}, 'identificationModule': {'nctId': 'NCT05464693', 'briefTitle': 'Microbiology in Obstructive BIliary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'Clinical-Microbiological Evaluation of the Obstructive Biliary Disease', 'orgStudyIdInfo': {'id': 'GA21-00003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with obstructive biliary disease', 'description': '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.', 'interventionNames': ['Diagnostic Test: ERCP biliary culture']}], 'interventions': [{'name': 'ERCP biliary culture', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['MALDI-TOF MS mass spectrometry for bacteria identification', 'Antibiotic susceptibility for identified bacteria'], 'description': 'The sample of biliary aspirate will be assessed as follows.\n\n1. Its macroscopic appearance will be analyzed: yellow, black, or purulent.\n2. 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.', 'armGroupLabels': ['Patients with obstructive biliary disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64620', 'city': 'Monterrey', 'state': 'Nuevo León', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Marusia González Villarreal', 'role': 'CONTACT', 'email': 'marusia1990@hotmail.com', 'phone': '8112525250'}], 'facility': 'Marusia González Villarreal', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'centralContacts': [{'name': 'Marusia González Villarreal', 'role': 'CONTACT', 'email': 'marusia1990@hotmail.com', 'phone': '8112525250'}, {'name': 'Joel Omar Jáquez Quintana', 'role': 'CONTACT', 'email': 'jomjaqui@hotmail.com', 'phone': '8114183484'}], 'overallOfficials': [{'name': 'Joel Omar Jáquez Quintana', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data sharing plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Dr. med. Hector Eloy Tamez Perez', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}