Biliary Candidiasis - Optimization of Diagnostics and Therapy
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ClinicalTrials.gov Identifier: NCT01109550 |
Recruitment Status
: Unknown
Verified December 2012 by University Hospital Muenster.
Recruitment status was: Recruiting
First Posted
: April 23, 2010
Last Update Posted
: December 10, 2012
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Condition or disease | Intervention/treatment |
---|---|
Secondary Cholangitis Bile Duct Strictures of Unknown Origin | Procedure: ERCP |
Background:
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 [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.
Study Aim:
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 ERCP procedure. In addition to mycological analysis of bile samples, tissue samples of the common bile duct are collected to confirm fungal invasion.
Study design:
The 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.).
Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure:
ERCP 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.
Ethics:
The 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.
Statistical methods:
The 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.
Study Type : | Observational |
Estimated Enrollment : | 80 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Biliary Candidiasis - Evaluation of Risk Factors, Implementation of an Algorithm in Diagnostics and Therapy |
Study Start Date : | April 2011 |
Estimated Primary Completion Date : | October 2013 |
Estimated Study Completion Date : | November 2013 |

Group/Cohort | Intervention/treatment |
---|---|
with biliary candidiasis
Patients with positive fungal cultures of bile samples.
|
Procedure: ERCP
endoscopic retrograde cholangiopancreatography transpapillary biopsies
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without biliary candidiasis
Patients with negative fungal cultures of bile samples.
|
Procedure: ERCP
endoscopic retrograde cholangiopancreatography transpapillary biopsies
|
- Diagnosis of an invasive fungal infection of the biliary tract [ Time Frame: 12 month ]
- 1. Evaluation of risk factors 2. Implementation of an algorithm in diagnostics and therapy [ Time Frame: 12 month ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Secondary cholangitis
- Bile duct strictures of unknown origin
- Age ≥ 18 years
- All individuals provide written informed consent before entering the trial
Exclusion Criteria:
- Exclusion criteria and contraindications of the performed procedure
- Ineffective aspiration of bile samples
- Pregnant or breastfeeding patient
- Age < 18 years
- Missing informed consent
- Missing cooperation (language barrier, amblyacousia, psychiatric disease)
- Refusal of participation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109550
Contact: Philipp Lenz, M.D. | 00492518346188 | Lenz.Philipp@ukmuenster.de | |
Contact: Dirk Domagk, M.D. | 00492518347559 | domagkd@uni-muenster.de |
Germany | |
Unitersity Hospital of Muenster, Department of Medicine B | Recruiting |
Muenster, Germany, 48149 | |
Contact: Philipp Lenz, M.D. 004925183476188 Lenz.Philipp@ukmuenster.de | |
Contact: Dirk Domagk, M.D. 00492518347559 domagkd@uni-muenster.de | |
Principal Investigator: Philipp Lenz, M.D. | |
Principal Investigator: Dirk Domagk, M.D. | |
Sub-Investigator: Hauke Heinzow, M.D. |
Study Chair: | Philipp Lenz, M.D. | University Hospital of Muenster | |
Study Chair: | Dirk Domagk, M.D. | University Hospital of Muenster |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT01109550 History of Changes |
Other Study ID Numbers: |
BILIARY-CANDIDIASIS_2010 |
First Posted: | April 23, 2010 Key Record Dates |
Last Update Posted: | December 10, 2012 |
Last Verified: | December 2012 |
Additional relevant MeSH terms:
Candidiasis Cholangitis Mycoses |
Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |