Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-28 @ 8:56 AM
Study NCT ID:
NCT01109550
Status:
COMPLETED
Last Update Posted:
2022-11-28
First Post:
2010-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biliary Candidiasis - Optimization of Diagnostics and Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}], 'ancestors': [{'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'bile samples, buccal smears, stool samples, blood samples, transpapillary biopsies (bile duct)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2010-04-21', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of an invasive fungal infection of the biliary tract', 'timeFrame': '12 month', 'description': 'Diagnosis of an invasive fungal infection of the biliary tract'}], 'secondaryOutcomes': [{'measure': 'Evaluation of risk factors 2. Implementation of an algorithm in diagnostics and therapy', 'timeFrame': '12 month', 'description': 'Risk factors'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Secondary Cholangitis', 'Bile Duct Strictures of Unknown Origin']}, 'referencesModule': {'references': [{'pmid': '1928197', 'type': 'BACKGROUND', 'citation': 'Banerjee SN, Emori TG, Culver DH, Gaynes RP, Jarvis WR, Horan T, Edwards JR, Tolson J, Henderson T, Martone WJ. Secular trends in nosocomial primary bloodstream infections in the United States, 1980-1989. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):86S-89S. doi: 10.1016/0002-9343(91)90349-3.'}, {'pmid': '8445217', 'type': 'BACKGROUND', 'citation': 'Bouche H, Housset C, Dumont JL, Carnot F, Menu Y, Aveline B, Belghiti J, Boboc B, Erlinger S, Berthelot P, et al. AIDS-related cholangitis: diagnostic features and course in 15 patients. J Hepatol. 1993 Jan;17(1):34-9. doi: 10.1016/s0168-8278(05)80518-5.'}, {'pmid': '17029620', 'type': 'BACKGROUND', 'citation': 'Domagk D, Fegeler W, Conrad B, Menzel J, Domschke W, Kucharzik T. Biliary tract candidiasis: diagnostic and therapeutic approaches in a case series. Am J Gastroenterol. 2006 Nov;101(11):2530-6. doi: 10.1111/j.1572-0241.2006.00663.x. Epub 2006 Oct 4.'}, {'pmid': '15727737', 'type': 'BACKGROUND', 'citation': 'George J, Baillie J. Contemporary Management of Biliary Tract Infections. Curr Infect Dis Rep. 2005 Mar;7(2):108-114. doi: 10.1007/s11908-005-0069-y.'}, {'pmid': '11792979', 'type': 'BACKGROUND', 'citation': 'Singh N, Wagener MM, Marino IR, Gayowski T. Trends in invasive fungal infections in liver transplant recipients: correlation with evolution in transplantation practices. Transplantation. 2002 Jan 15;73(1):63-7. doi: 10.1097/00007890-200201150-00011.'}, {'pmid': '9830582', 'type': 'BACKGROUND', 'citation': 'Wig JD, Singh K, Chawla YK, Vaiphei K. Cholangitis due to candidiasis of the extra-hepatic biliary tract. HPB Surg. 1998;11(1):51-4. doi: 10.1155/1998/75730.'}, {'pmid': '11336173', 'type': 'BACKGROUND', 'citation': 'Domagk D, Bisping G, Poremba C, Fegeler W, Domschke W, Menzel J. Common bile duct obstruction due to candidiasis. Scand J Gastroenterol. 2001 Apr;36(4):444-6. doi: 10.1080/003655201300051397.'}, {'pmid': '19555935', 'type': 'BACKGROUND', 'citation': 'Lenz P, Conrad B, Kucharzik T, Hilker E, Fegeler W, Ullerich H, Heinecke A, Domschke W, Domagk D. Prevalence, associations, and trends of biliary-tract candidiasis: a prospective observational study. Gastrointest Endosc. 2009 Sep;70(3):480-7. doi: 10.1016/j.gie.2009.01.038. Epub 2009 Jun 24.'}, {'pmid': '12117887', 'type': 'BACKGROUND', 'citation': 'Domagk D, Poremba C, Dietl KH, Senninger N, Heinecke A, Domschke W, Menzel J. Endoscopic transpapillary biopsies and intraductal ultrasonography in the diagnostics of bile duct strictures: a prospective study. Gut. 2002 Aug;51(2):240-4. doi: 10.1136/gut.51.2.240.'}, {'pmid': '8213710', 'type': 'BACKGROUND', 'citation': 'Kubota Y, Takaoka M, Tani K, Ogura M, Kin H, Fujimura K, Mizuno T, Inoue K. Endoscopic transpapillary biopsy for diagnosis of patients with pancreaticobiliary ductal strictures. Am J Gastroenterol. 1993 Oct;88(10):1700-4.'}, {'pmid': '8633492', 'type': 'BACKGROUND', 'citation': 'Sugiyama M, Atomi Y, Wada N, Kuroda A, Muto T. Endoscopic transpapillary bile duct biopsy without sphincterotomy for diagnosing biliary strictures: a prospective comparative study with bile and brush cytology. Am J Gastroenterol. 1996 Mar;91(3):465-7.'}, {'pmid': '11839709', 'type': 'BACKGROUND', 'citation': 'Tamada K, Tomiyama T, Wada S, Ohashi A, Satoh Y, Ido K, Sugano K. Endoscopic transpapillary bile duct biopsy with the combination of intraductal ultrasonography in the diagnosis of biliary strictures. Gut. 2002 Mar;50(3):326-31. doi: 10.1136/gut.50.3.326.'}, {'pmid': '25232260', 'type': 'DERIVED', 'citation': 'Lenz P, Eckelskemper F, Erichsen T, Lankisch T, Dechene A, Lubritz G, Lenze F, Beyna T, Ullerich H, Schmedt A, Domagk D. Prospective observational multicenter study to define a diagnostic algorithm for biliary candidiasis. World J Gastroenterol. 2014 Sep 14;20(34):12260-8. doi: 10.3748/wjg.v20.i34.12260.'}]}, 'descriptionModule': {'briefSummary': 'Biliary obstruction and cholangitis are common problems in gastroenterology and need specific therapeutic interventions. Besides a variety of potential causes, infections of the biliary tract with Candida and other fungal species have increasingly been reported in the last few years. Especially interesting is the question, if patients with positive fungal cultures of bile samples should be treated or not and under which circumstances. The primary aim of the present study is to evaluate wether positive fungal cultures of bile samples indicate fungal infection of the biliary tract, rather colonization or simply contamination during endoscopic retrograde cholangiopancreatography (ERCP) procedure.', 'detailedDescription': 'Background:\n\nBiliary obstruction and cholangitis are common problems in gastroenterology and need specific therapeutic interventions. Besides a variety of potential causes, infections of the biliary tract with Candida and other fungal species have increasingly been reported in the last few years \\[1-6\\]. Fungal infections can even lead to common bile duct (CBD) obstruction, as previously reported \\[7\\]. Because of the difficulty of gaining bile samples, little is known about the microbial flora of the bile. In a first prospective, observational study, 123 consecutive patients undergoing ERCP for various indications were screened for fungal species \\[8\\]. According to this data Candida species may be very frequently be detected in the bile (54/123 patients, 44 % of the cases). As significant risk factors immunosuppression and long-term antibiotic therapy were identified. The main issue in this context is whether positive diagnostic findings represent fungal infection or fungal colonization. Especially interesting is the question, if patients with positive fungal cultures of bile samples should be treated or not and under which circumstances.\n\nStudy Aim:\n\nThe primary aim of the present study is to evaluate wether positive fungal cultures of bile samples indicate fungal infection of the biliary tract, rather colonization or simply contamination during ERCP procedure. In addition to mycological analysis of bile samples, tissue samples of the common bile duct are collected to confirm fungal invasion.\n\nStudy design:\n\nThe study is designed as a single-center, non-randomized, observational study. The conducting center is the University Hospital of Muenster, Department of Medicine B, Gastroenterology. The examinations are performed by two experienced gastroenterologists (D. D., H. U.).\n\nEndoscopic Retrograde Cholangiopancreatography (ERCP) procedure:\n\nERCP is performed using a conventional duodenoscope as described in the literature. To exclude contamination artefacts, smears of the endoscope working channel (elevator) will be taken before and after the examination. Furthermore buccal smears and stool samples will be taken to get an impression of the individual transient flora. Endoscopic transpapillary bile duct biopsy for diagnosing an invasive fungal infection will be performed. Transpapillary biopsies as confirmed by the present literature cause no increased risk for post-interventional bleeding and infection \\[9-12\\]. Additionally with routinely taken blood samples (hemoglobin and lipase), candida-antigen-serology and blood-cultures will be gained.\n\nEthics:\n\nThe study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki and was a priori approved by the local ethics committee of the University of Muenster.\n\nStatistical methods:\n\nThe data will be analyzed using standard statistical methods. As observational study, no power-analysis will reasonable - nevertheless data will be shown with confidence interval. All statistical analyses will be performed in cooperation with the Department of Medical Informatics and Biomathematics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to a hospital of maximum care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Secondary cholangitis\n* Bile duct strictures of unknown origin\n* Age ≥ 18 years\n* All individuals provide written informed consent before entering the trial\n\nExclusion Criteria:\n\n* Exclusion criteria and contraindications of the performed procedure\n* Ineffective aspiration of bile samples\n* Pregnant or breastfeeding patient\n* Age \\< 18 years\n* Missing informed consent\n* Missing cooperation (language barrier, amblyacousia, psychiatric disease)\n* Refusal of participation'}, 'identificationModule': {'nctId': 'NCT01109550', 'briefTitle': 'Biliary Candidiasis - Optimization of Diagnostics and Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Biliary Candidiasis - Evaluation of Risk Factors, Implementation of an Algorithm in Diagnostics and Therapy', 'orgStudyIdInfo': {'id': 'BILIARY-CANDIDIASIS_2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with biliary candidiasis', 'description': 'Patients with positive fungal cultures of bile samples.', 'interventionNames': ['Procedure: ERCP']}, {'label': 'without biliary candidiasis', 'description': 'Patients with negative fungal cultures of bile samples.', 'interventionNames': ['Procedure: ERCP']}], 'interventions': [{'name': 'ERCP', 'type': 'PROCEDURE', 'description': 'endoscopic retrograde cholangiopancreatography transpapillary biopsies', 'armGroupLabels': ['with biliary candidiasis', 'without biliary candidiasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Unitersity Hospital of Muenster, Department of Medicine B', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Philipp Lenz, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Muenster'}, {'name': 'Dirk Domagk, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}