Biliary Candidiasis - Optimization of Diagnostics and Therapy

This study is currently recruiting participants.
Verified December 2012 by University Hospital Muenster
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01109550
First received: April 21, 2010
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Secondary Cholangitis
Bile Duct Strictures of Unknown Origin
Procedure: ERCP

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biliary Candidiasis - Evaluation of Risk Factors, Implementation of an Algorithm in Diagnostics and Therapy

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Diagnosis of an invasive fungal infection of the biliary tract [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Evaluation of risk factors 2. Implementation of an algorithm in diagnostics and therapy [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

bile samples, buccal smears, stool samples, blood samples, transpapillary biopsies (bile duct)


Estimated Enrollment: 80
Study Start Date: April 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
with biliary candidiasis
Patients with positive fungal cultures of bile samples.
Procedure: ERCP
endoscopic retrograde cholangiopancreatography transpapillary biopsies
without biliary candidiasis
Patients with negative fungal cultures of bile samples.
Procedure: ERCP
endoscopic retrograde cholangiopancreatography transpapillary biopsies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to a hospital of maximum care.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109550

Contacts
Contact: Philipp Lenz, M.D. 00492518346188 Lenz.Philipp@ukmuenster.de
Contact: Dirk Domagk, M.D. 00492518347559 domagkd@uni-muenster.de

Locations
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.         
Sponsors and Collaborators
University Hospital Muenster
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Philipp Lenz, M.D. University Hospital of Muenster
Study Chair: Dirk Domagk, M.D. University Hospital of Muenster
  More Information

Publications:

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01109550     History of Changes
Other Study ID Numbers: BILIARY-CANDIDIASIS_2010
Study First Received: April 21, 2010
Last Updated: December 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Candidiasis
Cholangitis
Cholestasis
Constriction, Pathologic
Mycoses
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014